Press Release - September 10, 2013
Sernova And Medicyte To Collaborate On Cell-Based Therapy To Treat Haemophilia
* Novel Approach to Address Unmet Need for an
Effective Therapy *
LONDON, ONTARIO and HEIDELBERG, GERMANY-- (Marketwire -- September 10, 2013) - Sernova Corp. (TSX- V: SVA) and Medicyte GmbH, today announced that the companies have entered into a Material Transfer Agreement (MTA) to jointly evaluate the use of Medicyte's upcyte® cells in Sernova's Cell Pouch(TM) for the treatment of patients with haemophilia A.
The two companies have also entered into a nonbinding term sheet outlining the general terms of a collaboration for the pre-clinical and clinical development of the novel Cell Pouch(TM)/upcyte® combination product for the treatment of haemophilia A. The parties intend to complete negotiations of a definitive agreement while initial research is being carried out under the terms of the MTA.
"The joint development program with Medicyte is further indication that our Cell Pouch(TM) technology is versatile and has high potential to be employed for the treatment of a range of chronic diseases," said Dr. Philip Toleikis, President and CEO Sernova Corp. "We are in line with our strategy to expand the testing of the Cell Pouch(TM) in various indications by collaborating with leading cell-based therapy companies, such as Medicyte."
Dr. Joris Braspenning, CEO of Medicyte, added, "There is a great unmet medical need for the treatment of severe haemophilia A. We believe that Medicyte's upcyte® cells being sheltered in Sernova's Cell Pouch(TM) represent a promising combination of technologies to produce effective levels of Factor VIII, and to prevent excessive bleeding episodes of patients suffering haemophilia A. Together with Sernova, we are looking forward to evaluating the potential of a combined product."
Haemophilia A is the most common form of haemophilia and results from a deficiency of clotting Factor VIII to a level of less than 1% of the normal blood concentration. Haemophiliacs have prolonged bleeding which in areas such as the brain can be fatal or inside joints can be permanently debilitating. Approximately 20,000 people in the United States have the moderate or severe form of haemophilia A, as well as approximately 2,500 in Canada and 10,000 in Europe. Though there is no cure for haemophilia A, it is currently controlled with regular injections of recombinant clotting Factor VIII. Annual costs for the treatment of the disease may range from $60,000 to $260,000 per patient for a total cost of between $2-4B per year in North America and Europe.
Development of a product capable of producing an effective level of Factor VIII within the Cell Pouch(TM) environment has the potential to provide haemophilia A patients with better protection against dangerous episodes of excessive bleeding and greatly reduce annual therapy costs.
Continuation of the parties' joint studies beyond the MTA is subject to negotiation and execution of a definitive collaboration agreement.
Medicyte is specialised in the controlled generation and standardisation of human primary cell products in virtually unlimited quantities and of highest quality for cell therapy and cell-based R&D. Medicyte's proprietary technologies upcyte® and vericyte® enable researchers to expand human cells from different donors and from multiple tissues in a standardized procedure, thereby making these cells for the first time commercially available in high numbers and consistent quality. Beside their therapeutic applications, pharmaceutical companies are using upcyte® and vericyte® products for in vitro assays and ADMET testing.
For further information contact: Joris Braspenning, Ph.D., CEO Tel: +49 (6221) 72925-30 email@example.com www.medicyte.com
About Sernova Sernova Corp. is a clinical stage health-sciences company focused on commercializing medical technologies. Sernova is developing a platform technology based on the Cell Pouch(TM), Sertolin(TM) and therapeutic cells, for a number of chronic diseases, including insulin-dependent diabetes as a first indication and other cell therapies for diseases such as parathyroid disease, haemophilia, and Parkinson's disease. Sernova's goals for the Cell Pouch(TM) for diabetes include increasing the number of patients currently treated with intraportal delivery of donor islets and to provide a safe environment for sources of unlimited insulin-secreting cells such as insulin-producing stem cells and xenogeneic cells. This vision combined with local anti-rejection protection of the cells could enable millions of patients with insulin-dependent diabetes to be treated without limitation to availability of cells.
For further information contact: Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939 firstname.lastname@example.org www.sernova.com
Tony Russo, Ph.D. Russo Partners, LLC Tel: (212) 845-4251 email@example.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors - including availability of funds, the results of financing efforts, the results of research and product development activities -- that could cause actual results to differ materially from Sernova's expectations are disclosed in Sernova's documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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