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.