Cambridge, UK, January 22, 2013 / B3C newswire / -Domainex Ltd, specialists in drug discovery solutions and translational research support, has today announced that it is launching its Discovery STAR Award to support academic groups at the early stages of drug discovery.

Domainex’s STAR Award scheme will provide successful applicants with virtual hit screening using Domainex’s LeadBuilder platform and/or drug discovery consultancy services. The aim will be to bridge a current ‘funding gap’ for these activities, thereby allowing projects to progress to an inflection point that is suitable for larger external grant-funding schemes such as the TSB/MRC Biomedical Catalyst Fund, The Wellcome Trust’s SDDI scheme, European Union FP7, and MRC DPFS.  

Translational research is the conversion of early-stage discoveries into new health products. Domainex is a leader in the support of academic translational research and has secured funding with numerous groups at the forefront of drug target research. Once funding is in place, and in full collaboration with the academic partner, Domainex has then deployed its own capabilities in medicinal and computational chemistry, biochemistry and DMPK testing to progress hit compounds through to the identification of clinical candidate drugs.

Eddy Littler, Chief Executive Officer of Domainex, said: “Domainex has successfully supported numerous academic groups across Europe and UK to apply for drug discovery funding from a range of sources – these include The Institute of Cancer Research; St. George’s, University of London; and the University of Manchester. However, small-molecule hits are typically required before funding can be secured, and the application process can be challenging for those without a commercial background. Domainex’s Discovery STAR Award will enable this gap to be filled for the selected recipients.”

 
About Domainex
Domainex is a drug discovery company that provides services, including computational and medicinal chemistry, gene cloning and expression, to pharmaceutical and biotechnology companies and to academic research groups. It also offers a unique proprietary technology known as Combinatorial Domain Hunting which is a patented method for expressing difficult protein targets. LeadBuilder is the proprietary lead generation platform that has been developed by Domainex to provide unusually rapid and cost-effective access to high-quality hits. As such, it is particularly well-suited to the needs of groups engaged in translational research, and emerging biotechnology and pharmaceutical companies. Domainex is also developing its own pipeline of pre-clinical drug candidates.

Domainex is based on the Cambridge Science Park, England and has offices in the London Bioscience Innovation Centre.

About Domainex’s Discovery STAR award
Domainex has launched its Discovery STAR award to support the early stages of drug discovery for a chosen number of applicants to the scheme. At Domainex’s discretion, selected applicants will then be provided with drug discovery advice and selected services free of charge in order to prepare applicants for funding applications to schemes such as the Wellcome Trust SDDI, Technology Strategy Board, Biocatalyst Fund or MRC DPFS.

Domainex plans to operate this scheme every 6 months. The deadline for this round is 15^th March 2013.

Contact
Joanne McCudden
Head of Business Development
Joanne.mccudden@domainex.co.uk
Tel +44 (0)7775 437107

• Financing round closed with volume of about 4 Mio. EUR
• VRD GmbH and WIC GmbH become new investors
• Prof. Dr. Ralf Wagner appointed as Managing Director
• Expansion of product portfolio in the field of T-cell based diagnostics

Regensburg, Germany, January 22, 2013 / B3C newswire / - Lophius Biosciences, a leading developer of novel, innovative T-cell-based diagnostic test systems, announced today the closing of a further financing round. With VRD GmbH and WIC GmbH two new investors will financially support the company alongside existing investors such as S-Refit, HighTech Gründerfonds (HTGF), Bayern Kapital and two Business Angels. With a commitment of about 4 Mio. EUR, Lophius Biosciences intends to fully introduce its technologies and products in the field of T-cell based diagnostics. Prof. Dr. Ralf Wagner, former CEO of GeneArt AG, has been appointed as Managing Director in order to drive the further development of the company together with the current Managing Director Dr. Michael Lutz.

Prof. Wagner was founder, CEO and CSO of Regensburg-based company GeneArt AG which specialized in the field of synthetic biology. Following the acquisition by Life Technologies in 2010 he was responsible as Site leader and Vice President Synthetic Biology for the successful integration of GeneArt AG into Life Technologies. As professor for molecular microbiology and gene therapy, Dr Wagner is also member of the Medical faculty at the University of Regensburg.

„We are very pleased that the positive development of Lophius Biosciences could be continued and even accelerated with these new funds. With their commitment, the new and existing investors have strongly validated the (recent) successful product developments for the CE-marked T-Track© CMV and EBV-Tests and T-Track© TB (Tuberculosis) based on our two patented technology platforms” said Dr. Michael Lutz, Managing Director of Lophius Biosciences.

Prof. Wagner’s strong focus will be on the successful rounding off and launch of the product portfolio together with Dr. Lutz and the whole Lophius Biosciences team. “Lophius Biosciences is a young but very innovative biotech company with the potential to become a fully integrated player in the new field of T-cell based diagnostics. Based on its proprietary know-how the company has many unique selling points for its products to provide significant diagnostic and clinical value to patients and physicians in a number of medical indications. I am happy to become part of this very interesting opportunity”, added Prof. Wagner.

„Together with the expanded management the existing investors highly welcome both VRD GmbH and WIC GmbH as new investors who strongly support the current company and investor strategy. With the addition of Prof. Wagner to the management board, the company has clearly accomplished another key milestone. Prof. Wagner and the existing Managing Director Dr. Lutz will form a strong team with outstanding expertise for developing small and medium-sized companies“, added Mr. Bertram Gilka-Bötzow, Head of Lophius Biosciences´ Advisory Board and Investment Director of S-Refit, the current Lead Investor of Lophius Biosciences.

About Lophius Biosciences
Lophius Biosciences GmbH develops and markets innovative T-cell based testing systems for diagnostics and possible therapy control in the fields of transplantation, infection and autoimmune diseases.

About VRD GmbH
VRD GmbH belongs to a family office of a renowned family of entrepreneurs. VRD primarily invests in companies with a strong business model coupled with a high potential and an ambitious management. Sustainability for past, current and future generations is considered a key element in a fair partnership.

About WIC GmbH
WIC GmbH is a young investment and consulting firm with a focus on identifying biotech companies with innovative technologies and on supporting these companies during the early development stages. The aim of WIC is to jointly develop technologies and products with existing management up to market launch. Doing this in an open partnership will deliver sustainable company success and will allow WIC to participate at the long-term value creation.

Contact:

Lophius Biosciences GmbH
Josef-Engert-Str. 13
93053 Regensburg, Germany
Phone: +49 941 6309 1972
info@lophius.de
www.lophius.de

Montreal, Canada, January 22, 2013 / B3C newswire / - TVM Life Science Ventures VII today announced an investment into Kaneq Bioscience Ltd. based in Montreal, Quebec. This company is a spin out of Kaneq Pharma Inc., a biotechnology company developing early stage compounds for metabolic diseases and cancer. Kaneq Bioscience Ltd. was specifically created to develop a protein tyrosine phosphatase1B (“PTP-1B”) inhibitor for treating type 2 diabetes mellitus. “Other approaches targeting PTP-1B have shown efficacy in the clinic but oral small molecules have remained elusive. Our compound has promise as an orally active insulin sensitizer that can be paired with existing therapies.” stated Dr. Daniel Bouthillier, CEO of Kaneq Pharma Inc., who has joined Kaneq Bioscience Ltd. as Executive Chairman. Dr. Cynthia Lavoie, General Partner of TVM Capital Life Science and Board Member of Kaneq Bioscience Ltd. adds: “We are pleased to collaborate with Kaneq Pharma to create a company in Montreal which addresses a huge market need for diabetes patients”.

This is the first investment for TVM Life Science Ventures VII, a life sciences venture fund domiciled in Montreal QC, which follows a new investment approach to developing pharmaceutical assets to a human proof-of-concept in single asset companies. This approach has proven to be highly capital efficient through a high degree of outsourcing while creating an opportunity for faster exits through a trade sale to a pharmaceutical player looking to build its pipeline without having to take on legacy companies around the products that appeal to them.

Kaneq Bioscience Ltd. will tap into the rich ecosystem of service providers in the area to bring its asset to human proof-of-concept, including expertise provided by Montreal-based Chorus Canada, an offshoot of global-early-phase drug development network Chorus, an autonomous unit of Eli Lilly and Company. The company is also benefitting from the involvement of Kaneq Pharma management, a highly experienced team with complementary skills in pharmaceutical development.

About TVM Capital Life Science
TVM Capital Life Science is providing venture capital to the international pharmaceutical, biopharmaceutical and medical technology industries with more than 25-years of transatlantic investment track record and in excess of US$1.1bn under management. The Life Science Investment Group’s mission is to invest in the development of exciting early stage drug candidates and companies in the medical field that are or aspire to be innovative leaders in their market segment. Since 1984, TVM Capital Life Science made 116 investments in life science companies in Europe and the United States and exited from 85 companies, including 41 initial public offerings on the NASDAQ, and the London, Frankfurt, Zurich and Vienna Stock Exchanges and 25 trade sales and mergers. The Life Science team combines long-standing international investment and company building experience with their track record of dedicated board work, extensive global networks in the world of life science research and product development and a direct knowledge of the local markets. TVM Capital Life Science currently invests from its 7th fund generation, TVM Life Science Ventures VII, with an integrated team of investment professionals based in in Montreal and Munich. More information: www.tvm-lifescience.ca; www.tvm-lifescience.com or twitter: tvmcapital

General Partner
TVM Life Science Ventures VII (GP) Ltd.
11-15 Seaton Place,
St Helier, Jersey
JE4 0QH, Channel Islands

Investment Advisor
TVM Life Science Management Inc.
2 Place Alexis Nihon, Suite 902
3500 Blvd De Maisonneuve West, Westmount,
Montréal, QC H3Z 1X5 Canada

About Kaneq Bioscience
Kaneq Bioscience Ltd, Montreal, is a spinout of Kaneq Pharma, a discovery and early development stage pharmaceutical company formed by former employees of the Merck Frosst Center for Therapeutic Research. This group has extensive drug discovery experience and has been intimately involved in the discovery of several marketed drugs plus novel therapies for hypertension and diabetes currently in clinical development. The focus of Kaneq Pharma is the delivery of high value molecules for validated targets in the areas of metabolic disease and cancer.

Contacts:

TVM Capital Life Science:
Dr. Cynthia Lavoie
General Partner
lavoie@tvm-capital.com
Phone: 514-931-4111

Dr. Hubert Birner
Managing Partner
TVM Capital Life Science
birner@tvm-capital.com
Phone: 514-931-4111

Kaneq Bioscience Ltd.

Dr. Daniel Bouthillier
Executive Chairman
daniel.bouthillier@kaneqbioscience.ca
Phone: 514-402-1764

• Anti-midkine antibodies reduced mortality rate and preserved kidney function in a mouse model of diabetic nephropathy
• Kidney damage markedly reduced in treated animals
• Additional data bolsters preclinical antibody data package
• Large unmet medical need for patients with kidney disease

Sydney, Australia, January 24, 2013 / B3C newswire / - Cellmid Limited (ASX: CDY) has completed its first in-life diabetic nephropathy study with the Company’s anti-midkine antibodies (MK-Ab) in a mouse model of the disease. Two of Cellmid’s proprietary MK-Ab’s were tested. Both antibodies reduced kidney damage significantly, as assessed by functional and histological analysis, with kidney structure largely preserved in the treated animals.

This study provides important new information, as it is the first time the Company has used its own MK-Ab’s in a therapeutic setting in a kidney disease model.

Renal histological assessment showed that glomerular sclerosis was reduced from 48% in untreated animals to below 20% in both MK-Ab treated groups (p<0.01). Interstitial volume was also significantly reduced, from 35% in untreated animals to 12% in both antibody groups (p<0.01). MK-Ab treatment also maintained tubular cell height; untreated animals had mean cell heights below 2μm, compared to 4μm for treated animals (p<0.05).

Kidney function was also preserved, with MK-Ab treated animals showing reduced protein leakage into the urine compared to untreated controls. Protein casts in the kidney, indicating damage, were also significantly reduced in antibody treated animals (Figure 1). Importantly, the MK-Ab treated animals showed healthy weight gain and reduced mortality compared to untreated controls; only 6.3% of treated animals died before the end of the study, compared to 25% of the untreated animals.

Figure1. Anti-MK antibodies reduce protein cast deposits in the kidneys of mice with AN-induced nephropathy.
Photographs show representative histological sections from treated and untreated mice. Protein casts are bright pink; yellow arrows indicate large protein cast deposits.

Midkine’s role in kidney disease has been extensively studied in the past and is the subject of a dozen peer-reviewed publications. These studies show that MK is a key driver of inflammation and damage in a variety of kidney disease and injury settings.

The current study using Cellmid’s MK-Ab’s was conducted by scientists at the Centre for Transplantation and Renal Research (CTRR), based at the Westmead Millennium Institute and University of Sydney, Westmead Hospital, using an Adriamycin (AN)-induced mouse model of nephropathy. In this model, a single AN injection leads to kidney damage reminiscent of that seen in human diabetic nephropathy.

Diabetic nephropathy is the leading cause of chronic kidney disease globally. It is also one of the most significant long-term complications in terms of morbidity and mortality for patients with diabetes. In the USA alone, diabetes affects 26 million people, and the US Centre for Disease Control (CDC) estimates that as many as one in three adults could have diabetes by 2050 if current trends continue.

Currently, diabetic nephropathy is managed by keeping glucose levels under control, however many of the patients develop end stage renal disease (ESRD). It is estimated that 30-40% of all ESRD is caused by diabetic nephropathy.

ESRD requires the traumatic and costly interventions of kidney dialysis or transplant. A treatment that slowed or halted the progression of diabetic nephropathy into full-blown ESRD would have enormous benefits for the quality of life of diabetes sufferers in addition to reducing the massive costs associated with the treatment of ESRD.

A 2010 report by Kidney Health Australia estimated that dialysis costs between A$53,000 and A$79,000 per patient per year. The same report costed kidney transplants at A$81,000, with nearly A$12,000 per patient per year in ongoing costs (in 2008-9 dollars; http://www.kidney.org.au/LinkClick.aspx?fileticket=i759hVXpJI0%3D&tabid=635&mid=1837 ).

The results of this diabetic nephropathy study present a promising start to the Company’s review of the therapeutic potential of its anti-MK antibody portfolio. It will contribute to the decision to select a lead disease indication Cellmid can then take into the clinic.

About Cellmid Limited (ASX: CDY)
Cellmid is an Australian biotechnology company developing innovative novel therapies and diagnostic tests for inflammatory diseases, heart attack and cancer. Cellmid holds the largest and most comprehensive portfolio of intellectual property related to midkine and midkine antagonists globally. The Company’s most advanced development programs involve using its anti-midkine antibodies for the treatment of cancer as well as inflammatory and autoimmune disorders. In addition, Cellmid is commercialising midkine as a biomarker for cancer diagnosis. Elevated midkine concentration in the blood and other body fluids is strongly indicative of cancer. Cellmid’s first product, the MK-ELISA, is a blood test that sensitively and accurately measures serum midkine levels.

About Midkine (MK)
Midkine is a multifunctional growth factor that is highly expressed during embryonic development. Midkine modulates many important biological interactions such as cell growth, cell migration and cellular adherence. These functions are relevant to cancer, inflammation, autoimmunity, ischemia, nerve growth/repair and wound healing. Midkine is barely detectable in healthy adults and only occurs as a consequence of the pathogenesis of a number of different disorders. Midkine expression is often evident very early in disease onset, even before any apparent physical symptoms. Accordingly, midkine is an important early marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only present in a disease context, targeting midkine does not harm normal healthy tissues.

Contact:
Maria Halasz, CEO
T +612 9299 0311

• The highest possible rating for ecological and sustainable building design; the world’s first Platinum-certified manufacturing facility to supply the biopharmaceutical industry

Goettingen, Germany | Yauco, Puerto Rico, January 25, 2013 / B3C newswire / – Sartorius Stedim Biotech, a leading international equipment provider for the pharmaceutical industry, has now been awarded the highest certification for ecological and sustainable building by the U.S. Green Building Council (USGBC) for its new facility in Yauco, Puerto Rico. According to the LEED certification system, an internationally recognized green building program, the new building was certified as “LEED Platinum.” As a result, Sartorius is the only company worldwide to have a LEED Platinum-certified manufacturing facility for the biopharmaceutical industry. LEED provides building owners and operators with a framework for identifying and implementing practical and measurable green building design, construction, operations and maintenance solutions.

Sartorius invested 20 million U.S. dollars in the new production building, which was officially opened in the summer of 2012, after approximately one year of construction. Covering an area of 5,000 square meters, or some 55,000 square feet, the new eco-friendly building complex provides space for two new cleanrooms for filter and bag manufacture, labs and offices. From the beginning, ecological aspects played a role in the project; special attention was given to conserving water and energy resources. The new building complex in Yauco has been designed to save approximately 85% of water consumed in comparison with conventional facilities. It uses harvested rainwater and air-handling unit condensate for cooling cleanrooms and supplying gray water to facilities, as well as for irrigation purposes. The building’s climate control technology, special building materials, and perforated metal fins and diaphanous screen walls that reduce sunlight contribute to energy savings. In addition, Sartorius Stedim Biotech covers approximately 10% of its energy needs for the new building with a photovoltaic system, which is installed on the factory roof.

“We are very proud to have received this prestigious rating for our new facility in Yauco from the USGBC organization. It acknowledges the green building measures that Sartorius has taken to ensure protection of the environment. Our innovative building sets new standards and proves that careful planning enables ecological and economical concerns to be reconciled,“ stated Volker Niebel, member of the Executive Committee of Sartorius Stedim Biotech.

Sartorius has been represented since 1982 in Puerto Rico by its wholly owned production facility in Yauco, where it employs some 240 people. The new facility in Yauco is one of the three major building projects undertaken over the past year to expand manufacturing infrastructure and to support the further growth of the Sartorius Group.

Current Image Files:

Sartorius Stedim Biotech’s new manufacturing facility in Yauco, Puerto Rico:
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Volker Niebel, member of the Executive Committee of Sartorius Stedim Biotech:
http://www.sartorius.de/fileadmin/media/global/company/Sartorius_Niebel_RGB.jpg

Single-use filters and bags are utilized in the manufacture of biopharmaceutical medications:
http://www.sartorius.com/fileadmin/media/global/company/sartorius_filter_bag.jpg

Certification mark “LEED Platinum”:
http://www.sartorius.com/fileadmin/media/global/company/certificate_leed_platinum.jpg

A Profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions.” Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 2,850 people, and in 2011 earned sales revenue of 477.3 million euros.

About USGBC and LEED
The U.S. Green Building Council (USGBC) and its community are changing the way buildings and communities are designed, built and operated. Its members believe in better buildings; places that complement the environment and enhance communities. Places that give people better, brighter, healthier spaces to live, work and play. Green building is win-win, offering both environmental and economic opportunity. Greater building efficiency can meet 85 percent of future demand for energy in the United States and a commitment to green building has the potential to generate 2.5 million jobs.

USGBC is made up of tens of thousands of member organizations, chapters and student and community volunteers that are moving the building industry forward in a way that has never been seen before. The council is a diverse group of builders and environmentalists, corporations and nonprofits, teachers and students, lawmakers and citizens. Today the Council consists of 77 chapters, 13,000 member organizations and 181,000 LEED professionals that share the same vision of a sustainably built environment for all within the next generation.

LEED (Leadership in Energy and Environmental Design) is a voluntary, consensus-based, market-driven program that provides third-party verification of green buildings. From individual buildings and homes, to entire neighborhoods and communities, LEED is transforming the way built environments are designed, constructed, and operated. Comprehensive and flexible, LEED addresses the entire lifecycle of a building.

Participation in the voluntary LEED process demonstrates leadership, innovation, environmental stewardship and social responsibility. LEED provides building owners and operators the tools they need to immediately impact their building’s performance and bottom line, while providing healthy indoor spaces for a building’s occupants.

LEED projects have been successfully established in 135 countries. International projects, i.e., those outside the United States, make up more than 50% of the total LEED registered square footage. LEED unites us in a single global community and provides regional solutions, while recognizing local realities.

Contact:

Sartorius Stedim Biotech
Dominic Grone
Group Corporate Communications
+49 (0)551.308.3324
dominic.grone@sartorius.com

Oxford, UK and Regensburg, Germany, January 29, 2013 / B3C newswire / - Oxford Immunotec, a medical diagnostic company developing tests in the fields of infectious and immunological disease and Lophius Biosciences, a leader in the field of novel T-cell based diagnostic test systems, announced today that the companies have signed agreements under which both companies will have access to certain intellectual property from the other party. Oxford Immunotec will be able to develop and commercialize novel T-cell based assays using Lophius´ proprietary UREA technology in certain territories. Lophius Biosciences will be able to develop and commercialize novel T-cell based assays under a license to Oxford Immunotec's proprietary T-SPOT® technology. Financial terms were not disclosed.

Dr. Peter Wrighton-Smith, Chief Executive Officer, Oxford Immunotec commented: “We believe that Lophius’s UREA technology has distinct advantages over conventional methods of designing and producing antigens for T-cell based diagnostic test systems. We are looking forward to combining Lophius’s technology with our own, to develop and launch innovative new assays for infectious and immunological disease”.

“We are very pleased with this partnership with Oxford Immunotec, a leading company in the development of T-cell based assays, which provides us access to the T-SPOT® technology. This cooperation also confirms the commercial potential of our proprietary UREA technology platform which led to recent successful development of two CE-marked tests, namely T-Track® CMV and T-Track® EBV.” said Dr. Michael Lutz, Managing Director of Lophius Biosciences.

About Lophius Biosciences
Lophius Biosciences GmbH develops and markets innovative T-cell based testing systems for diagnostics and possible therapy control in the fields of transplantation, infection and autoimmune diseases.

About Oxford Immunotec
Oxford Immunotec Ltd., a global immunology-focused diagnostic company, is headquartered near Oxford, UK; with US operations in Marlborough, MA and Memphis, TN and Japanese operations in Tokyo. The company is developing novel tests in the fields of infectious and immunological disease based primarily on its patented T-SPOT® technology, the first FDA-approved method for directly quantifying antigen-specific T cells.

T-SPOT technology is a simple and extremely accurate method of studying a person’s cellular immune response and, as such, provides a unique methodology to diagnose and monitor diseases driven by a T cell response.

Contacts

Lophius Biosciences GmbH
Josef-Engert-Str. 13
93053 Regensburg, Germany
Phone: +49 941 6309 1972
Email: info@lophius.de
www.lophius.de

Oxford Immunotec, Ltd
94C Milton Park
Abingdon
Oxfordshire OX14 4RY, UK
Phone: +44 1235 442780
Email: info@oxfordimmunotec.com
www.oxfordimmunotec.com

Vienna, Austria, January 29, 2013 / B3C newswire / – Zytoprotec, a company developing novel peritoneal dialysis solutions and other treatments based on active cytoprotection, today announced that is has raised EUR 2 million in financing from new investor Baxter Ventures towards a EUR 4 million Series A financing. Baxter Ventures is an investment initiative established by Baxter International in 2011 to invest up to USD 200 million in promising companies. As a result of the financing Norbert Riedel, Ph.D., Baxter’s Chief Science and Innovation Officer will join Zytoprotec’s Supervisory Board.

Zytoprotec’s most advanced product, PD-protec™, is a next-generation solution for peritoneal dialysis (PD) designed to actively protect abdominal cells. The peptide used as the cytoprotective component of PD-protec™ is patent-protected by Zytoprotec. The product has completed a Phase I/II trial in 2012 and a Phase II trial is planned to commence in early 2013.

“We are very pleased to add Baxter to our investor base, given the company’s longstanding expertise and leadership in PD therapy”, Peter C. Weilguni, Chief Executive Officer of Zytoprotec, commented. “We welcome Dr. Riedel to the Board of our Company as we are preparing PD-protec™ for a Phase II clinical trial.”

“Zytoprotec offers an exciting technology opportunity to protect the peritoneal membrane”, commented Norbert Riedel, Ph.D, Baxter’s Chief Science and Innovation Officer. “A peritoneal dialysis solution that holds the potential to prolong treatment time on PD would bring significant benefits to patients with kidney disease.”

About PD-protec™ and Peritoneal Dialysis
PD-protec™ is being developed as a next-generation solution for peritoneal dialysis (PD), an established treatment for patients suffering from renal failure. PD-protec™ is designed to actively protect abdominal cells, thus potentially improving treatment outcomes for patients on PD.

Out of 2.5 million patients depending on dialysis worldwide, approximately 250,000 are treated with PD. Due to the ageing of the population and growing incidence of diabetes and high blood pressure, the number of dialysis patients (including PD) is growing and there is greater opportunity and need for advanced and differentiated solutions to meet patient needs.

About Zytoprotec
Zytoprotec is a clinical stage biotechnology company developing drugs exploiting active cytoprotection as a novel therapeutic approach. Research by Zytoprotec has shown that in major diseases the capability of cells to protect against stress factors such as metabolic products is inhibited, but can be restored by intervention with cytoprotective pharmaceuticals. The Company has established a research platform for the identification of cytoprotective compounds.

Since its inception in 2007, and prior to this new investment, the Company has raised EUR 6.7 million from its founders, from corporate, private and institutional investors, as well as from Austrian public agencies.

Company contact Zytoprotec:
Peter C. Weilguni, CEO
Zytoprotec GmbH
Stadiongasse 2 / 13
1010 Vienna
AUSTRIA
+ 43 – 1 - 406 2002
office@zytoprotec.com

Media contact Zytoprotec:
Frank Butschbacher
Butschbacher Investor Relations & Communications
+43-650-7844940
office@butschbacher.net

Amsterdam, the Netherlands, February 4, 2013 / B3C newswire / - Specialized Medical Services-oncology BV (SMS-oncology), a Contract Research Organization (CRO) fully dedicated to conducting clinical cancer studies, today announced its Management Team has been changed and expanded to five executive members: Edwin Klumper (Chief Executive Officer, CEO), Philine van den Tol (Chief Operating Officer, COO), Eric van der Putten (Chief Business Development Officer, CBDO), Wouter Wijker (Managing Director Biometrics Unit), and Raymond Hoffmans (Director Consultancy).

The new CEO Edwin Klumper will succeed Eric van der Putten who will take on the position of CBDO. In his new role Eric will be responsible for driving new business opportunities and growing our client base. Edwin Klumper stated: "All credits go to Eric van der Putten who has been the driving force into building a fully GCP compliant CRO from scratch within five years that has resulted into ISO 9001:2008 certification in 2012. Our clients will benefit discussing their new cancer studies with Eric who brings to the table 30+ years of experience in running phase I and II cancer trials in close collaboration with the top tier of oncologists. His experience and operational insights will be of great value to our clients in achieving their objectives.”

Philine van den Tol has been promoted to the position of COO. With her no-nonsense and can-do attitude Philine motivates and leads by example the operational staff of SMS-oncology. She knows what it takes to run multiple multicenter cancer studies from her past experience as project manager for the Dutch Breast Cancer Trialists’ Group. The Management Team is completed by Raymond Hoffmans (Director Consultancy) and Wouter Wijker (Managing Director Biometrics Unit).

We thank Erik Leferink who has been leading in the foundation of SMS-oncology. Erik will hand over his business development responsibilities to Eric van der Putten. As a serial entrepreneur Erik will reallocate his time to grow new ventures that he has recently established. Erik will remain active as a shareholder of SMS-oncology.

“These changes reflect our steady growth and mark our next step”, said Edwin Klumper. “After 5 years of serving over 50 clients, building a highly motivated and oncology experienced staff, expanding our trial base across Europe, collaborating with top oncology centers, we are ready for our next step and ambition to become a European premier oncology CRO. It is a privilege to lead such a good team and serve our clients to jointly improve cancer treatment by developing new drugs that are desperately needed by so many patients".

About SMS-oncology
SMS-oncologyis a Contract Research Organization (CRO) that contributes to the overall success of oncology product development by assisting pharma & biotech companies and Investigators with the design and full execution of clinical development and research programs. SMS-oncology is committed to sharing its oncology expertise with Sponsors and Investigators in the interest of fully uncovering the potential of new oncology products for daily practice.

For further information please contact:

Mahjouba Rkhaoui (M.Rkhaoui@SMS-oncology.com)
Eric van der Putten (E.vanderPutten@SMS-oncology.com)

• Development of apceth’s first innovative “Advanced Therapy Medicinal Product” based on modified adult stem cells for cancer therapy
• apceth as participant in the “m4 Personalized Medicine and Targeted Therapies” initiative of the Munich Biotech Cluster
• A total of 4.7 million € of approved budget in two funding phases

Munich, Germany, February 4, 2013 / B3C newswire / – As of January 2013 apceth has entered the second round of funding for the development of its first cancer therapeutic based on patient’s own modified adult mesenchymal stem cells (MSC) running under the portfolio name Agenmestencel-T.

In December 2012 apceth has successfully concluded the first 2.5-year round of funding through the Federal Ministry of Education and Research (BMBF) for the development of Agenmestencel-T as part of the Munich Biotech Cluster initiative “m⁴ Personalized Medicine and Targeted Therapies” (Cluster project PM5, FKZ: 16EX1021K).

The Munich Biotech Cluster comprises a rich network of biotech and pharma companies, research institutions and clinical centers in order to promote and expedite the creation of the future orientated personalized and targeted therapy strategies. As the winner of the second round of the “Leading-Edge Cluster Competition” in 2010 the Munich Biotech Cluster has at its disposal a considerable funds granted by BMBF and the Bavarian Government within its “m⁴ Personalized Medicine and Targeted Therapies” initiative for this ambitious aim.

The second round of funding through BMBF apceth was granted at the end of 2012 as part of the m⁴ Cluster initiative. With this apceth’s total approved budget for the development of Agenmestencel-T amounted to 4.7 million € within a period of less than five years between July 2010 and March 2015.

Agenmestencel-T is a highly innovative stem cell-based medicinal product for personalized therapy of advanced and/or metastatic cancers. With Agenmestencel-T apceth is committed to provide a novel cell-based cancer drug which will be custom-made for every single patient. Combining the stringent principles of pharmaceutical development with targeted biomarker-based strategies for patient stratification, apceth aims to create the cancer drugs of uppermost quality and safety, while identifying those cancer patients that can mostly benefit from this novel cell therapy.

About apceth
apceth is one of the leading European pioneers in the development, GMP manufacturing and clinical implementation of innovative stem cell-based therapies for the treatment of malignant and non-malignant diseases. apceth combines the principles of stem cell biology with groundbreaking technologies, applying the highest standards for GMP manufacturing, safety regulations and quality control according to the European Regulation for “Advanced Therapy Medicinal Products” (ATMPs). apceth provides novel cell therapy solutions for the treatment of clinical conditions for which no satisfactory treatment options are available to date. The proven know-how in all aspect of ATMP pharmaceutical development and GMP production (GMP manufacturing license, §13 and §20b AMG) enable apceth also to offer the contract manufacturing services for diverse ATMPs.

apceth was founded in 2007 as a start-up company and is privately owned by its founders and private investors.

Contact:
Dr. Christine Günther, CEO
Prof. Dr. Ralf Huss, CSO

apceth GmbH & Co. KG
Max-Lebsche-Platz 30
D-81377 Munich
Germany

Phone: +49 (0)89-7009 608-0
Email: contact@apceth.com
www.apceth.com

Uppsala, Sweden, February 6, 2013 / B3C newswire / –Biotage® (STO: BIOT), a leading global supplier of solutions and technology for analytical and medicinal chemistry, introduced their new 2013 catalog of analytical sample preparation products for chemistry professionals.

The significantly streamlined and user friendly 2013 edition includes a comprehensive range of products for bioanalysis, forensic, clinical, environmental, agrochemical and food applications. The catalog is available by contacting a Biotage representative or by visiting www.biotage.com.

Included in the 2013 catalog is the EVOLUTE® EXPRESS range of polymeric SPE plates, offering a simplified and robust Load-Wash-Elute methodology that significantly reduces sample preparation time and solvent use whilst maintaining high, reliable analyte recoveries.

The new 2013 catalog is supplemented with a new and improved EVOLUTE User Guide, also available now. Biotage will also release during 2013 a new ISOLUTE SLE+ User Guide as well as industry specific guides to assist with method development, troubleshooting and application support across the full range of Biotage analytical chemistry products.

“Biotage sample preparation products are offered at the highest quality with a dedicated support network established to assist our customers in method development and problem solving” says Gavin Jones, Global Product Manager. “At Biotage we develop innovative scientific solutions and supply in-depth technical support that simplifies method development which in turn provides reliable and reproducible results. The specific expertise in sample preparation we can offer aids customers in choosing the right product and most efficient method that best suits their analytical needs.”

The 2013 catalog is a perfect complement to the detailed and specific information available in Biotage’s searchable Application Database found at www.biotage.com/applications.

For further information visit www.biotage.com or call: in Europe +46 18 56 57 10, in North America toll free 1 800 446 4752, in Japan +81 422 28 1233, other areas please call +46 18 56 57 10.

About Biotage
Biotage offers solutions, knowledge and experience in the areas of analytical and medicinal chemistry. Customers include the world’s top pharmaceutical and biotechnology companies, as well as leading academic institutes. The company is headquartered in Uppsala, Sweden, with offices in China, Japan, the United Kingdom, the United States and a worldwide network of distributors. Biotage has 272 employees with sales of 428.4 MSEK in 2011. Biotage is listed on the NASDAQ OMX Nordic Stock Exchange.

 
Contact:

James Churchill
Marketing Communications
Biotage GB Ltd
Distribution Way
Dyffryn Business Park
Ystrad Mynach
Hengoed, Wales CF82 7TS
United Kingdom
Tel: +44 (0)1443 811 849
Mobile: +44(0)7875484778
Email: james.churchill@biotage.com

Uppsala, Sweden, February 6, 2013 / B3C newswire / – Biotage (STO: BIOT), a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, has announced the launch of an updated version of its Isolera™ Spektra software with improvements to the time and solvent saving step gradient optimization feature. The updated software uses TLC data from 2 to 10 different TLC runs to estimate where the individual sample components will elute, the percentage of strong solvent required and which cartridge is best capable of purifying the amount of sample to be purified.

This patent-pending technology helps chemists to tailor the purification to separate and purify between one and six compounds in the sample or even target one specific compound of interest, which can reduce purification costs 60% or more over conventional, non-compound specific linear gradients. Furthermore, the simplicity of the software makes it easy for even the most inexperienced users to take advantage of sophisticated purification strategies.

“The launch of the Biotage® Isolera™ Spektra in 2012 was a revolution in flash purification, moving 1-dimensional flash into 2D and 3D with a purification system capable of targeting specific compounds in complex mixtures, and even detecting the presence of normally invisible impurities beneath peaks of interest. It has and will continue to positively change the way we think about flash purification” says Dr. Sunil Rana, Product Manager, Biotage®. “This latest update extends the step-gradient application range to include the new high capacity Biotage® SNAP Ultra and Biotage ZIP® Sphere cartridges.”

For further information visit www.biotage.com or call: in Europe +46 18 56 57 10, in North America toll free 1 800 446 4752, in Japan +81 422 28 1233, other areas please call +46 18 56 57 10.

About Biotage
Biotage offers solutions, knowledge and experience in the areas of analytical and medicinal chemistry. Customers include the world’s top pharmaceutical and biotechnology companies, as well as leading academic institutes. The company is headquartered in Uppsala, Sweden, with offices in China, Japan, the United Kingdom, the United States and a worldwide network of distributors. Biotage has 272 employees with sales of 428.4 MSEK in 2011. Biotage is listed on the NASDAQ OMX Nordic Stock Exchange. 

Contact:

James Churchill
Marketing Communications
Biotage GB Ltd
Distribution Way
Dyffryn Business Park
Ystrad Mynach
Hengoed, Wales CF82 7TS
United Kingdom
Tel: +44 (0)1443 811 849
Mobile: +44(0)7875484778
Email: james.churchill@biotage.com

• Option to License agreement signed for the Company’s diagnostic technology
• Cellmid to receive an upfront option fee and supply its diagnostic antibodies
• Multiple cancer diagnostic products are expected to be developed
• Agreement further validates Cellmid’s midkine diagnostic technology

Sydney, Australia, February 11, 2013 / B3C newswire / - Cellmid Limited (ASX: CDY) has signed an important option agreement with listed Japanese company Fujikura Kasei Co Ltd (Fujikura), a major supplier of latex particles used in medical diagnostics.

Under the terms of the Option to License agreement Cellmid will supply its proprietary anti-midkine diagnostic antibodies for validation on Fujikura’s latex platform. Cellmid will receive an initial fee and a further payment should Fujikura elect to exercise its license option. Cellmid will also receive royalties on any future midkine diagnostic products sold by Fujikura.

The license agreement will proceed on condition that Fujikura is able to reach a limit of detection (LOD) of 500 picogram/mL midkine in serum on its proprietary latex diagnostic platform. Cellmid’s highly sensitive MK-ELISA detects midkine to a limit of 8 picogram/mL, and Fujikura is planning to achieve a LOD close to that level on its latex platform using the same antibody pair.

Healthy individuals usually have serum midkine levels below 500 picogram/mL. A latex based test with a 500 picogram/mL LOD means that the test will be able to identify individuals with elevated midkine levels, which may lead to the development of a number of cancer diagnostic products. Fujikura has regulatory and product development programmes in place to accelerate this path to market.

A latex based assay will be highly beneficial for the commercial launch of any midkine diagnostic product, as it is widely used and accepted in pathology laboratories. It is also preferred as it can easily be automated, reducing processing costs.

“We are very excited about this opportunity as the midkine diagnostic platform lends itself to multiple, high value product development opportunities,” said Fujikura’s Head of Medical Project Division, Dr Hideyuki Kuroda.

Cellmid CEO Maria Halasz said she was confident the partner company’s expertise in latex based diagnostics would ensure success in achieving the required LOD for a midkine test.

“Fujikura is the ideal partner for us as they have a strong focus on building their medical diagnostic business and consider midkine an important part of this commercial expansion,” she said.

Midkine has been extensively validated as an early marker for a range of cancers and has also been shown to be useful in prognosis and disease management.

Cellmid has already licensed its patents for the early diagnosis, prognosis and disease monitoring of lung cancer (Celera-Quest) and bladder cancer (Pacific Edge Biotechnology). This latest agreement further validates the Company’s midkine diagnostic technology.

About Cellmid Limited (ASX: CDY)
Cellmid is an Australian biotechnology company developing innovative novel therapies and diagnostic tests for inflammatory diseases, heart attack and cancer. Cellmid holds the largest and most comprehensive portfolio of intellectual property related to midkine and midkine antagonists globally. The Company’s most advanced development programs involve using its anti-midkine antibodies for the treatment of cancer as well as inflammatory and autoimmune disorders. In addition, Cellmid is commercialising midkine as a biomarker for cancer diagnosis. Elevated midkine concentration in the blood and other body fluids is strongly indicative of cancer. Cellmid’s first product, the MK-ELISA, is a blood test that sensitively and accurately measures serum midkine levels.

About Fujikura Kasei Co Ltd
Fujikura Kasei is a Japanese company listed on the Tokyo Stock Exchange with headquarters in Tokyo. Established in 1938, Fujikura Kasei Co Ltd is a fine chemical company traditionally with core strengths in coating materials, electro-conductive materials, polymers and resins, serving electronics, automobiles, buildings industries. With its platform technologies in particle size and shape control, hybridization, functionality and processing, Fujikura Kasei is one of the largest suppliers of latex particles used in medical diagnostic based on latex coagulation technology.

About Midkine (MK)
Midkine is a multifunctional growth factor that is highly expressed during embryonic development. Midkine modulates many important biological interactions such as cell growth, cell migration and cellular adherence. These functions are relevant to cancer, inflammation, autoimmunity, ischemia, nerve growth/repair and wound healing. Midkine is barely detectable in healthy adults and only occurs as a consequence of the pathogenesis of a number of different disorders. Midkine expression is often evident very early in disease onset, even before any apparent physical symptoms. Accordingly, midkine is an important early marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only present in a disease context, targeting midkine does not harm normal healthy tissues.

Contact:
Maria Halasz, CEO
T +612 9299 0311

Nottingham, UK, February 12, 2013 / B3C newswire / - Critical Pharmaceuticals today announces that it has successfully completed a second clinical study on its CP024 growth hormone nasal spray. The results of this trial in healthy subjects showed that CP024 is safe and well tolerated with pharmacokinetics that are highly reproducible ensuring accuracy and ease of dose titration. Uniquely for a nasal formulation, CP024 strongly induces the production of insulin-like growth factor (IGF-1), which is the principal mediator of growth hormone activity.  

Dr Gareth King, CEO Critical Pharmaceuticals commented “We are very excited about the latest clinical results with CP024 which provide clear proof of concept for this product, and which will support our search for a suitable development and commercialization partner to progress the product into phase 2/3 clinical studies. As well as providing an attractive alternative to injection, we believe CP024 may have clinical benefits by reducing circulating growth hormone levels which reduce insulin sensitivity seen with current treatments of growth hormone while maintaining therapeutic IGF-1 levels.”

In the clinical trial, six dose levels of CP024 (between 2-6 mg growth hormone) were administered to healthy subjects along with an infusion of octreotide to suppress the production of endogenous growth hormone. The objectives of the study were to measure the pharmacokinetics, pharmacodynamics and dose response relationship of CP024 compared to a subcutaneous dose of 0.75 mg Omnitrope®.

Results confirmed:

• CP024 was well tolerated and the few adverse events observed were mild and transient and similar to those observed with over the counter marketed nasal products (e.g. Beconase®).
• CP024 pharmacokinetics were highly reproducible and importantly showed a linear dose response indicating that it would be possible to accurately set and titrate dose in children and adults.
• Insulin-like growth factor 1 (IGF-1) was strongly induced after dosing with CP024 and is the only reported product to induce therapeutic levels of this important biomarker after intranasal administration. IGF-1 is produced in the liver in response to systemic growth hormone and is the principal mediator of its growth promoting effects.

The need for new products to treat growth hormone deficiency

Human growth hormone (hGH) is a leading biological drug for the treatment of growth disorders in adults and children with global sales in excess of $3bn in 2011. All marketed growth hormone products require subcutaneous injection and CP024 nasal growth hormone offers an attractive non-invasive route for delivery. Non-adherence to hGH therapy is estimated to be as high as 66% with 70% of patients unhappy with daily injection and 30% considering stopping treatment. As well as reduced efficacy, non-adherence also leads to increased healthcare costs. Nasal delivery provides an attractive alternative; studies show that for vaccine delivery, where there is a choice, children prefer nasal administration over injections.

CP024 is a dry powder formulation of hGH containing CriticalSorb™ absorption promoter, a best in class nasal absorption promoter, and delivered using an easy to use nasal spray device. CriticalSorb™ is a marketed pharmaceutical excipient with an extensive toxicology package demonstrating its safety profile. Critical Pharmaceuticals has pending patents in major territories for CriticalSorb™ and its CP024 nasal growth hormone product.

CP024 has been developed with funding support from the Wellcome Trust.

About Critical Pharmaceuticals
Critical Pharmaceuticals is a Nottingham UK-based biotechnology company developing a pipeline of unique biological drug products utilizing its proprietary drug delivery technologies. These technologies enable the development of sustained release injectable depot and nasal delivery of proteins and peptides and small molecular weight drugs. As well as developing its own pipeline, Critical Pharmaceuticals works in partnership with other pharmaceutical and biotechnology companies to enhance the delivery of their novel drug products.

About the Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust’s breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests.

For more information, please contact

Dr Gareth King, CEO, Critical Pharmaceuticals
Tel: +44 (0) 115 882 0100
gareth.king@criticalpharmaceuticals.com

Quantitative biomarker analysis advanced by alliance between Advanced Cell Diagnostics and Definiens, providers of breakthrough platform for in situ RNA biomarker detection and leading image analysis technology for digital pathology

Munich, Germany/Hayward, California, USA, February 12, 2013 / B3C newswire / – Definiens and Advanced Cell Diagnostics (ACD) today unveiled the details of the RNAscope SpotStudio image analysis software to attendees at the Molecular Medicine Tri-Conference meeting in San Francisco, USA. The software has already been sold to a top pharmaceutical company and a leading academic medical center under an early access program. This advanced image analysis solution brings objective and accurate quantification to RNA in situ hybridization and enables a new generation of diagnostic applications based on single cell analysis. For the first time, gene expression can be measured quantitatively at single-cell resolution and interpreted by pathologists within histopathological context.

Empowering Pathologists with an Easy-to-Use Tool for Quantitative Biomarker Analysis

Quantitative RNA in situ hybridization analysis has recently been made possible by the single molecule sensitivity and digital nature of RNAscope® assay technology. However, manual scoring is time consuming and prone to subjectivity and poor reproducibility. RNAscope SpotStudio software is designed for pathologists with no prior training in image analysis. It is an intuitive automated solution that generates standardized and objective results in minutes. Testing has shown that results obtained with RNAscope SpotStudio are comparable to careful manual annotations by pathologists. The software is compatible with image data from whole slide scanners and microscopes.

“In situ biomarker analysis tools such as immunohistochemistry (IHC) have been limited to subjective semi-quantitative scoring. RNAscope and the SpotStudio image analysis software take in situ biomarker analysis to a whole new level, where quantitative data at the single cell level can be obtained and interpreted within the histopathological context of the clinical specimen”, said Yuling Luo, Founder, President and CEO of ACD. “RNAscope combines the advantages of IHC and PCR, making it a superior tool for tissue-based diagnostics and companion diagnostics”, Dr. Luo added. “Definiens’ invaluable expertise with tissue image analysis made it an ideal partner for the joint development of RNAscope SpotStudio.”

“Coming from a leading position in providing image analysis solutions to the life sciences market, Definiens is rapidly expanding its footprint in tissue diagnostics. We are very excited about this partnership with ACD representing a great example of advanced diagnostic solutions based on Definiens image and data analysis capabilities that will drive next generation diagnostics to truly enable personalized medicine”, said Thomas Heydler, CEO of Definiens.

Definiens and ACD will showcase RNAscope SpotStudio at the Molecular-Med Tri-Con in San Francisco (booth 210). The solution will be marketed and distributed by ACD and is currently being distributed to selected customers in an early access program. General availability is planned for the second quarter of 2013.

While RNAscope Spot Studio supports the analysis of brightfield images, RNA FISH assays can be quantified with Definiens Tissue Studio®. With over 450 deployed licenses, Definiens Tissue Studio is the leading image analysis solution for digital pathology. Beyond the detection of spot-like stains, Definiens Tissue Studio provides morphological and molecular expression profiles from any solid tissue (IHC and IF) on a cell-by-cell basis.


About Definiens
Definiens is the leading provider of image analysis and data mining solutions for life sciences, tissue diagnostics and clinical digital pathology. Definiens software provides detailed cell-by-cell readouts from target structures on whole tissue slides, and allows the correlation of this information with data derived from other sources. By automating analysis workflows, Definiens helps pharmaceutical and biotechnology companies, research institutions, clinical service organizations and pathologists to generate new knowledge and support better decisions in research, diagnostics and therapy. Definiens’ vision is to open new fields of research, to contribute to development of personalized medicine and to significantly improve the quality of patients’ lives.

Definiens is headquartered in Munich, Germany and has offices throughout the United States. Further information is available at www.definiens.com.

About Advanced Cell Diagnostics
Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell- and tissue-based research tools for all areas of biomedical research, and diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the most sensitive method available for RNA ISH, and the first quantitative and fully automated platform enabling multiplex fluorescent and chromogenic RNA biomarker analysis. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.

Media Contacts
Definiens AG
Dr Florian Leiss
Manager Marketing Communications
+49 (89) 2311-8024
fleiss@definiens.com

Advanced Cell Diagnostics
Steve Chen, PhD
Chief Operating Officer
+1 (510) 259-9802
schen@acdbio.com

Cambridge, UK, February 14, 2013 / B3C newswire / - Domainex Ltd., a UK-based drug discovery company, has announced an investment round to raise £1.5m of capital. This round had a successful first close in December 2012, with investments made by Longbow Capital, Bury Fitzwilliam-Lay and Partners and University College London Business (UCLB), who together represent the interests of more than half of Domainex’s current shareholders.

Longbow Capital is leading the round and will now seek to raise the remaining investment before a second close at end of April. Edward Beckett, Managing Partner at Longbow, commented “We are very pleased with the progress Domainex has made on its drug development pipeline and on its service business. The further investment will help to develop a range of drug compounds that can address some of the most acute diseases. This has already generated interest from many leading pharmaceutical companies and is expected to drive growth in Domainex’s value for its shareholders”.

The investment will be used to advance Domainex’s kinase based drug development programmes against TBK1/IKKe and epigenetics targets. Edward Littler CEO of Domainex said ‘Over the last year Domainex’s programmes targeting TBK1/IKKe have made great strides, showing utility in cancer, and also potential in many inflammatory diseases. We are now approaching the selection of a clinical candidate and some of the investment will be used to ensure we move this programme forward to an out-licensing deal with a pharma partner.’ He added: “The majority of the investment will be used to progress our epigenetics portfolio targeting lysine methyltransferases. With the increased strength of the service business and the additional investment, Domainex’s resources should be sufficient to deliver a number of exciting clinical drug candidates that larger pharmaceutical companies are interested in.

Keith Powell Chairman of Domainex said “It is exciting to see Domainex moving the internal drug development programmes forward to create value while at the same time building and strengthening its effective and impressive drug discovery technology partnering business. Recently Domainex has obtained new contracts to support UK universities in translational research and has a number of future opportunities to expand its capabilities further during 2013 ”

 
About Domainex

• Domainex uses unique and proprietary technologies to resolve common bottlenecks facing the pharmaceutical and biotechnology industries in the post-genomic era. Major discovery 'gaps' exist between the vast amount of genomic information that is now available, the accessibility of the corresponding proteins for use in target validation and drug discovery, and the identification of robust hits in a cost effective manner. Founded in 2002, Domainex is a privately owned company based in Cambridge, UK.
• Domainex has developed a discovery platform, which enables rapid progression of drug discovery projects from novel target through to Candidate Drug by means of its Combinatorial Domain Hunting technology, LeadBuilder virtual hit screening software, and its integrated approach to medicinal and computational chemistry.
• Domainex’s patented CDH technology enables the cloning and expression of soluble drug target protein domains in E. coli, followed by the identification of those constructs that are able to bind a ligand. This enables binding assays to be developed, facilitating hit identification studies. In only 3-4 months, all expressible ligand binding domains of a target protein are identified (from libraries of 20,000-100,000 constructs), enabling key rate limiting steps in early drug discovery to be easily overcome and resulting in large time savings over standard approaches.
• Domainex has also developed LeadBuilder - a virtual screening approach for targets which is specifically aimed at quickly identifying hit molecules that are ideally suited for further development.
• The experienced medicinal chemistry team has a proven track record in supporting biotech or university groups by providing expertise to take hit compounds through lead optimization and on to candidate selection. Three compounds to date arising from these collaborations are currently in clinical evaluation, with two additional drugs in preclinical studies.

Contact:

Joanne McCudden
Head of Business Development
Joanne.mccudden@domainex.co.uk
Tel +44 (0)7775 437107

Experts from the CDMO to discuss the challenges and solutions facing the industry

Ravensburg, Germany, February 19, 2013 ­/ B3C newswire / – Changing markets and potential solutions will be the highlight at the 15th Pharma Congress Production & Technology in Duesseldorf, Germany, March 19 - 20. Vetter, one of the worlds’ leading Contract and Development Manufacturing Organization, will present on a variety of informative core developments critical to the international pharmaceutical and biotech industries. Udo J. Vetter, chairman of the Vetter advisory board, will present the keynote address at the Congress focusing his comments on the future demands and challenges in pharmaceutical manufacturing. Vetter experts will address various topics including the needs for filling monoclonal antibodies, advantages and solutions of restricted access barrier systems (RABS) and the implementation of isolators for sterility tests as well as Vetter’s own supplier management system and the company’s new Center for Visual Inspection and Logistics.

Major changes taking place among the world’s leading pharmaceutical and biotech companies demand creative solutions to complex challenges by the manufacturing industry. The 15th Pharma Congress Production & Technology held in mid-March, will bring together representatives from the private and public sectors to discuss the current market trends. Vetter, an international specialist in aseptic filling, will present on best practices in sterile manufacturing and packaging.

Presenter and topics include Udo J. Vetter, who will be focusing on aseptic manufacturing at the Congress's keynote. The chairman of the Vetter advisory board will be speaking about the current market trends and their long-term effects on sterile production. He will also discuss changing technological and regulatory requirements and how innovative and flexible production plants can provide answers.

Joerg Zimmermann, Director Process Development and Implementation will present two case studies including Vetter’s experiences with fill-and-finish considerations for monoclonal antibodies and how certain challenges are already being met in the early phases. His second case study will cover the function and advantages of the restricted access barrier systems (RABS) in aseptic manufacturing and how to operate a RABS-based line successfully based on real life experience. Mr. Zimmermann will also moderate the ECA Barrier Systems Conference, one of the key sessions of the Congress.

Dr. Andreas Reicke, Team Coordinator at Vetter’s microbiology division will review a case study on the implementation of sterility test isolators. He will talk about regulatory demands and considerations in regards to design, location and utilities as well as project planning from beginning through to implementation.

Uli Kuchenbrod, Director Incoming Goods at Vetter, will give his insights into Vetter‘s supplier management system and incoming inspections as part of quality control. He will also address the operative challenges as well as the strategic considerations between a CDMO and its suppliers.

Thomas Ruebekeil, Director Investment Projects will introduce the new Vetter Ravensburg site. He will present the project plan and best practice as well as provide an update on the Center for Visual Inspection and Logistics including characteristics of the building itself and the use of regenerative energy and how it can be safely and efficiently used in the pharmaceutical sector.

All of the presentations are consistent with the goal of the international event which is to present lectures as technical applications "from users for users", primarily concentrating on their practical benefits.

About Vetter
Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Its clientele includes the world’s top 10 pharma/biotech firms and emerging companies alike. A full-service provider, Vetter supports products throughout their lifecycles, from preclinical development through global market supply. Through its U.S. and European facilities, Vetter Development Service provides state-of-the-art support for early-stage products, with seamless transfer at Phase III to Vetter Commercial Manufacturing for large-scale production. The company is the originator of dual-chamber technology, which enables easier, safer lyophilized-drug administration; and is a leader in the use of RABS technology in cleanrooms, which mitigates risk of product contamination during the manufacturing process. Vetter has won numerous awards for innovation and quality, including top prize at the 2012 European Outsourcing Awards for its new high-speed filling line. Headquartered in Ravensburg, Germany, the company employs approximately 3,000 staff across Europe and the United States.

Contact
Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg
Phone: +49 (0)751-3700-3023
Fax: +49 (0)751-3700-7707
E-mail: PRnews@vetter-pharma.com
www.vetter-pharma.com

Berlin, Germany, February 20, 2013 / B3C newswire / – Another global pharma company has licensed ProBioGen’s GlymaxX® ADCC-enhancement technology. The license covers the modification of the pharma’s antibody production platform for the generation of antibodies with enhanced potency. The continued licensing success demonstrates the industry’s endorsement of GlymaxX®. The GlymaxX® technology is highly versatile since it can be applied to any starter or production cell line. It allows both, the robust permanent modification of established antibody expression platforms, as well as the rapid conversion of existing antibody producer clones to produce ADCC-enhanced molecules.

The GlymaxX® technology is based on the stable expression of a heterologous enzyme in the antibody producing cells. GlymaxX® prevents antibody fucosylation almost completely, but moreover allows the exact adjustment of any desired fucosylation level through the controlled addition of fucose into the culture medium.

The license with an option for a commercial license covers the modification of the company’s antibody production platform and the generation of multiple antibodies with enhanced ADCC potency. Financial details are not disclosed.

The technology can be licensed royalty-free, based on milestone-dependent license fees only.

About ProBioGen
ProBioGen is an internationally operating technology provider and Contract Development and Manufacturing Organization (CDMO) with almost 20 years of experience in cell culture, process development, and GMP-manufacturing. ProBioGen is a competent and reliable CDMO partner, offering customized solutions for even the most challenging development and manufacturing requirements. This is backed by the company’s established, fee-for-service-based CHO cell and media platform, and its innovative platform technologies, as well as the comprehensive portfolio of cell-based activity assays. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).

ProBioGen was founded 1994 and is located in Berlin, Germany.

About GlymaxX®
The GlymaxX® technology, developed by ProBioGen, prevents the addition of the sugar “fucose” to the N-linked antibody carbohydrate part by antibody producing cells. The absence of fucose is known to greatly enhance ADCC. The GlymaxX® technology is based on the introduction of a gene for an enzyme which deflects the producer cells’ pathway of fucose biosynthesis. GlymaxX® is universally applicable to different CHO hosts and other eukaryotic cell species, and it is simple and potent. GlymaxX® can be rapidly applied in a few weeks to any existing antibody producer cell line, or can be introduced into entire animal cell expression platforms by modifying host cell lines.

ProBioGen offers this technology royalty-free as service or as license to third parties.

Contact ProBioGen

Dr. Gabriele Schneider
Vice President Business Development
ProBioGen AG
Goethestrasse 54
13086 Berlin
Germany
Phone: +49 (0)30 924 006-0
Email: cmo@probiogen.de

More information:
www.probiogen.de
www.glymaxx.de

High quality long-read sequencing technology is providing new insights into previously unsequenced regions of the Human Reference Genome

Penzberg, Germany and Marco Island Florida, USA, February 22, 2013 / B3C newswire / - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a consortium consisting of researchers from Penn State University, the National Center for Biotechnology Information, Children’s Hospital Oakland Research Institute and Roche 454 Life Sciences is working on a new comprehensive de novo assembly of a human genome to augment and supplement the current human reference genome sequence. The team has presented the latest results today at the Advances in Genome Biology and Technology (AGBT) congress in Marco Island, Florida.

Under the leadership of Stephan Schuster, Ph.D., Professor at Penn State University, the consortium is analyzing and assembling the RP11 human reference genome as part of new efforts to close gaps in the human reference assembly using Roche’s 454 GS FLX+ Sequencer. To date, the draft assembly covers a significant number of the remaining human reference sequence gaps and has revealed 36 million bases of novel sequence, including novel genes with potential biological relevance.

“We are very proud to have been able to contribute to a project of such importance and potential impact on future genomic research with our unique long-read sequencing technology,” said Dan Zabrowski, Head of Roche Applied Science. “This project also shows the power of combining different innovative sequencing analysis and assembly technologies.”    

This new de novo assembly is quickly becoming the most complete available of the Human Reference Genome using next-generation sequencing technology. The size and contiguity of the new assembly matches that of previous Sanger-based assemblies, including the J. Craig Venter genome (HuRef) published in 2007. In total, the latest draft assembly fully spans 76 remaining gaps and extends into 13 additional repeat regions, as well as revealing a total of 36 million bases of novel genomic sequences.

“I am pleased with the overall progress of the project and the high quality of the assembly even at this early stage,” said Stephan Schuster. “The 454 Sequencing technology has proven to sequence entire human genomes with even coverage and the long reads enable Sanger-like sequencing of reference genomes.”

The current draft assembly was generated using a hybrid of 18X 454 GS FLX+ long read sequence data and 7.5X short read sequence data from the Illumina MiSeq and HiSeq platforms. De novo genome assembly was performed using the Roche 454 GS De Novo Assembler software (Newbler). Significant ongoing efforts to add additional sequence data and apply different bioinformatics strategies are expected to further improve the contiguity of the assembly and quality of results, which will be made publically available to the research community.

On the RP11 genome and the Human Genome Reference Sequence
For the Human Genome Project (HGP) published in 2001, researchers collected DNA samples from a large number of male and female donors. Only a few of the many collected samples were processed as DNA resources and donor identities were protected so neither donors nor scientists could know whose DNA was sequenced. Due to quality considerations, most of the sequence (~70%) of the Human Genome Reference Sequence (currently GRCh37) initially produced by the HGP and now managed by the Genome Reference Consortium came from a single anonymous male donor from Buffalo, New York by shotgun sequencing clones from the “RP11” BAC library. Samples from this original DNA were used in this latest assembly project and were provided in collaboration with Pieter de Jong, Ph.D., Children’s Hospital Oakland Research Institute.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

For further information please contact:

Roche Diagnostics
Dr. Claudia Schmitt
Phone: +49 8856 60 10210
Email : claudia.schmitt.cs2@roche.com

• Trabedersen clinical development program update
• Advances in ‘Next Generation’ TGF-β oligonucleotide program and expansion of scientific advisory board
• Organization streamlined and senior management strengthened
• Strong, continued support from investors

Regensburg, Germany, February 26, 2013 / B3C newswire / - The biopharmaceutical company Antisense Pharma GmbH, today announced its revised corporate and development strategy, receiving full support from its main investors.

The updated corporate strategy focuses on streamlining the organization to meet its current business objectives and strengthen key senior management positions in light of the new direction for trabedersen’s clinical development program and the advancement of Antisense Pharma’s ‘Next Generation’ TGF-β inhibitor oligonucleotide program.

Revised development path for Trabedersen
The data analysis of “SAPPHIRE” (G005), trabedersen’s early terminated phase III study in glioma, is in progress. Due to a need for additional outcome data collection, final results are now expected within the third quarter of 2013.

However, preliminary safety data analyses revealed that the benefit/risk ratio might not be in favor of the trabedersen treatment arm due to serious adverse events (SAE) associated with the local mode of administration of the drug in this trial. The convention-enhanced delivery (CED) of trabedersen via intra-cranial infusion with surgical catheter placement seemed to result in a distinct, clinically relevant imbalance of SAEs observed. In light of this finding, the company decided that the risk to the patient outweighs the potential clinical benefits for this type of administration of the drug. As a consequence, the company will no longer pursue further development of the local administration of trabedersen in glioma.

Future clinical development of TGF-β targeted drugs in glioma is still considered for the ‘Next Generation’ TGF-β oligonucleotide development program based on the encouraging survival data for anaplastic astrocytoma from an earlier glioma trial with trabedersen (G004).¹

From now onwards, trabedersen’s development path will only focus on the systemic intravenous (IV) mode of administration.

This decision is further supported by the findings from the Phase I/II clinical study (P001) presented at ASCO in June 2012.² The data demonstrated that the systemic IV administration of trabedersen treatment is safe and well tolerated by patients. First clinical signs of efficacy were observed in this study with encouraging survival outcomes for patients suffering from pancreatic cancer or malignant melanoma when compared to historical controls.

With this intent, Antisense Pharma is currently under way to launch a clinical Phase II study to evaluate systemic, intravenous trabedersen treatment in patients suffering from malignant melanoma, pancreatic cancer and other tumors by the second half of 2013. This clinical trial will be conducted in two stages. The first stage has a dose-confirmatory component and will further define the pharmacodynamic (PD) activity of trabedersen in terms of TGF-β2 target down-regulation as a primary PD parameter and immunomodulation in the selected patient populations. Upon successful completion of the first stage, the second stage of the study is set to demonstrate a survival benefit over standard chemotherapy for one or two key tumor indications in a larger patient population.

Dr. Philippe Calais, Chief Executive Officer of Antisense Pharma commented: “Our revised trabedersen clinical program takes into consideration all learnings from the G005 and P001 studies. We move forward with the systemic intravenous administration of trabedersen in a well-tailored, two stage clinical development program aiming at further optimizing our chances of success in the regulatory path leading to approval and market. This creative development approach minimizes the risk and costs usually associated with larger, less tailored programs. Indeed trabedersen holds a strong value for the company, as it is supported by orphan drug designation for several indications in the US and Europe as well as a fully validated manufacturing process. In parallel, we are also exploring partnership opportunities to further accelerate trabedersen’s development path.”

Progress of ‘Next Generation’ TGF-β oligonucleotide program and expansion of the scientific advisory board (SAB)
Since its foundation in 1998 Antisense Pharma has accumulated a vast amount of expertise and intellectual property by focusing its research and development efforts on the TGF-β pathway and on oligonucleotides in high-medical-need diseases in oncology. This expertise is unique in the world.

The company recently merged its indication-focused advisory boards into a single corporate SAB comprised of 11 established academics, researchers and clinicians who are worldwide leaders in fields of TFG-β, oncology, and oligonucleotides.

Upon strategic considerations from the company’s senior management team supported by recommendations from the SAB, Antisense Pharma started a ‘Next Generation’ TGF-β inhibitor oligonucleotide program that provides the company with a portfolio of additional assets, comprised of compounds specifically designed to down regulate the TGF-β pathway by targeting different TGF-β isoforms or combinations thereof, for the treatment of high unmet medical need cancer indications. These potent compounds have meanwhile shown highly impressive anti-TGF-β activity in initial preclinical evaluations.

Antisense Pharma is committed to aggressively move forward a number of potential lead candidates for further development and to explore development collaborations at an early stage to further accelerate those highly promising assets.

Dr. Michael Weller, Professor of Neurology and Chairman of the Department of Neurology at Zurich University Hospital, and member of the Antisense Pharma SAB, as well as having a strategic research collaboration with Antisense Pharma, commented: “The cytokine TGF-ß has a critical role in several tumors. As a soluble factor it travels through the body and hits immune cells which then are shut off and don’t recognize the tumor anymore. This is one of several ways how TGF-ß promotes tumor growth and invasion. Antisense Pharma pursues an important therapeutic approach to treat cancer by inhibiting TGF-ß. I am excited to test their next generation antisense TGF-ß inhibitors in our animal models and support their further clinical development.“

Organization streamlined and senior management strengthened
The revised corporate strategy necessitated an organizational streamlining to better suit the current business objectives.

Refocusing Antisense Pharma’s R&D efforts into lean and focused preclinical and clinical development programs did impact the organization. Accordingly, Antisense Pharma decided to outsource non-critical expertise and adjusted its headcount, reducing its workforce by half on February 1st, 2013. The company furthermore announced the addition of new talents in several key senior management positions. Added to the team are Eugen Leo, M.D. Ph.D. M.B.A., a board certified hematologist and medical oncologist and Professor of Medicine with a long-standing international targeted therapy clinical development experience in both academia and industry, and Michel Janicot, Ph.D., a biochemist, scientist and drug-developer with extensive global industry expertise in preclinical development of targeted therapies for oncology.

Dr. Philippe Calais, CEO of Antisense Pharma commented further: “I am convinced that the adaption of our development strategy and our refined corporate strategy is the right way to secure a sustainable portfolio of clinical assets for Antisense Pharma and at the same time reduces the risk for our investors. I am committed to build on our great expertise in the area of TGF-ß and oligonucleotide research. The strength of our refocused trabedersen development, our well defined pipeline, as well as our renewed efforts to shape the organization in a way to fit our new strategy will undoubtedly bring significant opportunities for a bright future for Antisense Pharma.“

The company’s long term main investors are fully supportive of the new corporate strategy of Antisense Pharma.

Dr. Matthias Kromayer of MIG commented: “We are fully supportive of the updated strategy presented by Dr. Calais and his newly appointed team of development experts. Considering the challenging environment, the entire Antisense Pharma team is doing a great job in streamlining the organization and focusing activities around Antisense Pharma’s core capabilities – the vast experience and skills in the area of TGF-ß, oncology, and oligonucleotide research. We are especially encouraged by the recent US FDA approval of the first systemic antisense drug,³ which further validates the scientific rationale of this drug technology platform. We are convinced that Antisense Pharma will be able to make a significant contribution to the development of innovative oligonucleotide therapies in oncology and expect management to deliver the promised development and corporate milestones.”

 
About Antisense Technology
Antisense compounds are biological molecules which consist of fragments of 2 to 20 ribonucleic acid (RNA) or deoxyribonucleic acid (DNA) nucleotides (oligonucleotides). They are designed to bind in a sequence-specific manner to a matching messenger ribonucleic acid (mRNA) known to code for a defined protein. The binding of an oligonucleotide to its matching mRNA sequence results in the degradation of the mRNA through enzyme-mediated pathways or disruption of mRNA function through binding alone. As a consequence the synthesis of a specific protein, which affects the onset and progression of a certain disease, is inhibited without altering the genome of the patient. Using antisense molecules to inhibit the synthesis of pathogenic proteins is an innovative therapeutic approach. It enables to treat the root of the disease and not merely its symptoms.

About the target protein TGF-beta
The cytokine human transforming growth factor beta (TGF-β) plays a key role in the progression of various aggressive tumors.^4-6 Its overexpression induces a profound state of cellular immunodeficiency and mediates the tumor´s escape from immunosurveillance. In addition, TGF-β plays a significant role in invasive tumor growth and the infiltration into non-affected tissue, in the promotion of tumor angiogenesis, as well as tumor cell migration and metastasis.

About Trabedersen
The antisense molecule trabedersen consists of 18 DNA oligonucleotides and is complementary to the human mRNA encoding for TGF-β2. Trabedersen, specifically designed to target the TGF-β2 mRNA, is believed to reverse its immunosuppressive effects, rendering the tumor visible to the patient’s immune system and resulting in priming and specific activation of the patient’s anti-tumor immune response. Trabedersen has been granted orphan designation for three tumor indications: high grade glioma (US, EU), pancreatic cancer (US, EU) and malignant melanoma (US). Trabedersen has been evaluated extensively in several preclinical and clinical studies across selected oncological indications. The compound has shown encouraging early signs of therapeutic activity in cancer patients.

About Antisense Pharma
Antisense Pharma GmbH is a biopharmaceutical company based in Regensburg and Munich, Germany, developing innovative therapies targeting the TGF-β pathway to treat tumor diseases with high unmet medical need. These therapies are highly specific and antisense technology based as they aim at enabling the body’s own immune system to respond against tumor diseases with a potentially long-lasting effect.
In addition, the company is expanding its pipeline through the development of a “Next Generation” TGF-β inhibitor oligonucleotide program identifying novel proprietary compounds to target cancer.
The private company was founded in 1998 and funded mainly by renowned private equity lead investor MIG and others such as S-Refit and Bayern Kapital.

References

1. Bogdahn U. et al. (2011): Targeted Therapy for High-Grade Glioma with the TGF-beta2 Inhibitor Trabedersen: Results of a Randomized and Controlled Phase IIb Study; Neuro-Oncology 13, doi: 10.1093/neuonc/noq142
2. Oettle H. et al. (2012): Final results of a Phase I/II study in patients with advanced pancreatic carcinoma, malignant melanoma, or colorectal carcinoma with trabedersen; ASCO American Society of Clinical Oncology #4034, abstract and poster presentation
3. Press Release (Jan-29-2013): Genzyme and Isis Announce FDA Approval of KYNAMRO™ (mipomersen sodium) Injection for the Treatment of Homozygous Familial Hypercholesterolemia
4. Akhurst R. J. & Hata A. (2012): Targeting the TGFβ signalling pathway in disease; Nature Reviews Drug Discovery 11: 790 - 811
5. Massagué J. (2012): TGFβ signalling in context; Nature Reviews Molecular Cell Biology 13: 616 - 630
6. Massagué J. (2008): TGFβ in Cancer; Cell. 25; 134(2):215-30. doi: 10.1016/j.cell.2008.07.001

Contact

Antisense Pharma GmbH
Dr. Andrea Kottke
Head of Medical Affairs & Communication
a.kottke@antisense-pharma.com
T. +49-941-92013-106

MC Services
Raimund Gabriel
raimund.gabriel@mc-services.eu
T. +49-89-210228-30

Mareike Mohr
mareike.mohr@mc-services.eu
T. +49-89-210228-40

Amsterdam, The Netherlands, February 26, 2013 / B3C newswire / – Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, announced today it has received the No Objection Letter from Health Canada for its new clinical study with ATIR™. This study will be a Phase II international multi-center study with clinical sites in Canada and Belgium. Up to 23 patients will be treated in this study to corroborate and extend the safety and efficacy results from Kiadis Pharma‘s previous Phase I/II clinical study with ATIR™. The coordinating investigator for the study will be Denis-Claude Roy, MD, professor of medicine at the University of Montreal. ATIR™ is a cell-based product designed to enable stem cell transplantations from mismatched (haploidentical) family donors.

“We are very happy that after having received approval from the Research Ethics Board of the Maisonneuve-Rosemont Hospital, we have now also gained approval from Health Canada and can commence with our new clinical study in Canada”, commented Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma. “This study will be an important step forward in developing ATIR™ as an innovative therapeutic option for severely diseased blood cancer patients. Today, many of these patients die because a matched stem cell donor cannot be found.”

Dr. Denis-Claude Roy added: “We are excited that we can start this Phase II clinical study with ATIR™ in which we will treat blood cancer patients for whom a matched donor is not available for a standard transplantation procedure. This study provides these patients with the opportunity to receive a stem cell transplantation from a family member with ATIR™ added as an adjunctive treatment to provide rapid and potent immune protection and minimize post-transplant risks.”

About ATIR™
ATIR™ is a cell based medicinal product candidate enabling stem cell transplantations from mismatched (haploidentical) family donors to patients suffering from blood cancer. Stem cell transplantation is the only potentially curative option for many patients but a matched donor is available for only half of the patients in need. ATIR™ thus has the potential to address this unmet need and to make stem cell transplantations available for patients worldwide.

Those T-cells in a haploidentical graft which would cause Graft-versus-Host-Disease (GvHD) are selectively eliminated using proprietary technology to produce ATIR™. ATIR™ is administered as an adjunctive treatment on top of a haploidentical stem cell transplantation enhancing early immune reconstitution without causing GvHD.

In a Phase I/II study with ATIR™, safety and proof of concept were provided in terms of absence of grade III/IV GvHD, reduced rates of infection, reduced Transplant Related Mortality and high Overall Survival.

ATIR™ has been granted Orphan Drug Designation both in the EU and the USA. Together, both regions represent a combined primary market potential of more than EUR 1 billion per year.

About Kiadis Pharma
Kiadis Pharma B.V. is a clinical stage biopharmaceutical company developing innovative and potentially life-saving therapies for patients with late stage blood cancers and related disorders, an area of significant unmet medical need.

The Company is collaborating with renowned centers in Europe, Canada and the United States to further develop ATIR™. Kiadis Pharma is based in Amsterdam, The Netherlands.

Contact

Manfred Ruediger, CEO

Kiadis Pharma

Entrada 231-234

1096 EG AMSTERDAM

The Netherlands

Tel. +31 20 314 02 50

communication@kiadis.com