Cardiac Cell Therapy Phase III Trial to Treat Refractory Angina
CryopraxisTM/CellPraxis® aims to start patient recruitment for its Phase III Refractory Angina Cell Therapy Brazilian arm clinical trial by the end of 2012 or early 2013. The phase IIA/B clinical trial study was completed in December 2011. These trials involved the use of a proprietary autologous stem cell formulation (MonocellTM) indicated for neoangiogeneses.
“Safety and efficacy of this product was evaluated in patients with refractory angina, a no option disease condition, characterized by severe chest pain for which there is no efficient treatment available,” says the President of both Companies, Eduardo Cruz.
ReACT®, MonocellTM's derived product, showed evidence of safety and efficacy in our initial clinical trials. All patients included in this trial were classified as Class IV Angina in CCSAC* (the most severe class of chest pain). In the first group of patients, whose data was published**, there was a progressive and sustained improvement in angina symptoms, with 87.5% of the patients completing the clinical trial with a CCSAC score of 0 or 1.
“Angina symptom relief began as early as 3 months post procedure with continuing improvement through the 18th month, suggesting that angiogenesis began early, and that it kept evolving 18 months after the procedure. Objective evaluation of stress myocardium perfusion (scintigraphic analysis), after 1 year of follow-up, gave indications of complete myocardial reperfusion in 75% of the patients,” says Dr. Nelson Hossne, Medical Director of CellPraxis®. Our conclusion was ReACT®'s specific cell formulation, MonoCell™, had a direct correlation to myocardial neoangiogeneses.
- *CCSAC - Canadian Cardiovascular Society Angina Classification
- **Cell Transplantation, Vol 18, 2009
Located at Bio-Rio Biotech Cluster (Rio de Janeiro, Brazil), CryopraxisTM is the pioneer and the largest bank of umbilical cord blood in Brazil and has been in operation since 2001, with approximately 25,000 customers. CellPraxis® is a bioengineering company that invests in research projects involving stem cell therapy. Some of these projects are conducted in partnership with institutions like the Federal University of Rio de Janeiro, Federal University of São Paulo, the University of South Florida and Saneron CCEL Therapeutics, Inc. (a USA based biotechnology company dedicated to stem cell research).
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
Germana Regazzi, +55 21 3035-6956