NeoStem, an international biopharmaceutical company with a focus on cell-based therapeutic development, and Amorcyte, a development stage cell therapy company focusing on novel treatments for cardiovascular disease, announced the closing of their previously announced merger transaction following approval by the shareholders of both companies on 14 October 2011. NeoStem, intends to initiate, no later than the first quarter of 2012, a phase II clinical trial for Amorcyte’s lead product candidate, AMR-001, for the treatment of acute myocardial infarction.
According to NeoStem, of the approximately 800,000 Americans who suffer an acute myocardial infarction each year, approximately 20% of patients, remain at risk for progressive deterioration in heart muscle function and, as a consequence, increased risk for future major adverse cardiac events. AMR-001 targets treatment of this unmet medical need.
AMR-001 is an autologous, bone marrow-derived, pharmaceutical grade cell-based product that uses a cell population enriched for CD34+CXCR4+ cells. Studies have shown that these cells act as a natural repair mechanism, releasing from bone marrow and traveling to the damaged region of the heart following an acute myocardial infarction. Treatment with AMR-001 involves infusion of an active population of these cells directly into a patient’s heart via an intra-coronary catheter six to eleven days after an acute myocardial infarction (i.e., after the “hot” or inflammatory phase) and as such complements the body’s natural rescue mechanism for those cells that face hypoxic stress (i.e., oxygen deprivation) as a result of an increased workload.
“We are very much encouraged by the phase I trial results and look forward to moving AMR-001 forward toward commercialisation through NeoStem,” said Andrew L Pecora, chief medical officer of NeoStem and chief scientific officer of Amorcyte. “Through NeoStem’s preclinical VSEL (very small embryonic-like stem cell) platform, the phase 1-ready autoimmune disease product candidates of its Athelos subsidiary, and now through AMR-001, NeoStem seeks to fulfill the promise that an individual’s own cells hold the potential to both heal and transform the way medicine is delivered.”
Robin L Smith, chairman and CEO of NeoStem said, “The closing of our acquisition of Amorcyte represents a leap forward for NeoStem into clinical development and the furtherance of our mission to develop a product portfolio of cell therapy products that leverage the body’s natural abilities to heal and fight disease. We believe that AMR-001 bridges the gap between cell therapy’s roots in bone marrow transplantation and cell therapies of the future.”