Amorcyte, LLC, a NeoStem, Inc. company (AMEX: NBS) announced the enrollment of the first patient in the Amorcyte PreSERVE Phase 2 trial for acute myocardial infarction. The study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of infarct-related artery infusion of AMR-001, an autologous bone marrow derived cell therapy enriched for CD34+ cells.
AMR-001 is administered 5 to 11 days post-stent placement in patients diagnosed with an ST segment elevation myocardial infarction with ejection fraction less than or equal to 48%, as determined by cardiac magnetic resonance imaging measured after recovery from myocardial stunning.
Approximately 160 subjects, age 18 and older, will be randomized 1:1 between the treatment group and control group. Progenitor Cell Therapy, LLC, also a NeoStem company, will support the manufacturing, product supply, and logistics for the trial.
Dr. Arshed Quyyumi, Professor of Medicine at Emory University and the lead principal investigator in the study said, “We are thrilled to begin evaluating AMR-001, a CD34+ cell therapy, in these patients. We look forward to Phase 2 trial confirmation of the biologic activity of AMR-001 demonstrated in the Phase 1 trial and hope to provide patients with significant clinical benefit and an enriched quality of life.“
“The first patient enrollment signals a key advance in our efforts in the trial,” said Dr. Andrew L. Pecora, Chief Medical Officer of NeoStem. “We are on track to enroll the targeted 160 patients over the next year or so with first data follow-up six months after the last patient is enrolled.“
AMR-001 represents the first compound in this class of cell therapies to have a highly defined cell population and an identified biologically effective therapeutic dose, both of which tie back to the biological mechanism of action that the outcomes of the current study are intended to demonstrate. The Amorcyte therapy is being developed initially for the preservation of heart muscle function for approximately 160,000 American patients who sustain a heart muscle damaging STEMI annually.
Dr. Pecora further added, “Even with current best clinical practices, this group faces a significant chance of adverse outcomes, including premature death. Our goal is to create significant pharmacoeconomic value by reducing the associated costs of adverse outcomes often seen in these patients. We feel AMR-001 has the potential to address a substantial unmet medical need.“
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