FRANKFURT, May 25, 2010 /PRNewswire/ -- t2cure GmbH, a biopharmaceutical company developing and marketing stem cell-based regenerative therapies, announced today that the quality of its lead product t2c001 has been certified by the European Medicines Agency (EMA).
t2c001 is the first product ever to obtain a certificate under the EMA regulations for Advanced Therapy Medicinal Products (ATMPs). It is a somatic cell therapy product derived from autologous bone marrow, that is currently developed for the treatment of cardiovascular diseases. ATMPs are advanced biotechnology products based on cell therapy, gene therapy, or tissue engineering.
"We are absolutely excited that our lead product has been confirmed to meet the rigorous quality requirements set by the EMA, the regulatory body that will decide on a future European market approval for our product", commented Dr Petra Rueck, CEO of t2cure. "Together with upcoming 5-year efficacy and safety data from our Phase II trial, the EMA Certification shows that we are on the right track to bring this groundbreaking therapy closer to the market, and to patients."
Rueck continued: "This achievement also proves that the regulations set out by the EMA for advanced therapy products and the expertise brought together by the EMA's Committee for Advanced Therapies effectively assist small and medium-sized companies in developing advanced therapy products. These products offer novel treatment opportunities for patients who suffer from diseases, including orphan diseases, for which there are limited or no treatment options."
ATMPs and European Regulation on ATMPs
Advanced therapy medicinal products (ATMPs) base
|SOURCE t2cure GmbH|
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