NEW YORK, Dec. 16, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, today announced completion of enrollment in its PreSERVE AMI study. PreSERVE AMI is a randomized, double-blind placebo-controlled Phase 2 clinical trial testing NeoStem's lead product candidate, AMR-001, an autologous adult stem cell product for the treatment of patients with left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI). With infusion of the target population of 160 patients complete, NeoStem expects data readout in the third quarter of 2014.
Dr. Jonathan-Sackner Bernstein, Vice President of Clinical Development, said, "With completion of enrollment, we are now closer to demonstrating the impact of AMR-001 in patients with left ventricular dysfunction after suffering a STEMI. We thank our patients, study coordinators, and investigators for their time and dedication to the study."
"With the timely achievement of full enrollment in this clinical trial we look forward to our clinical team applying the same successful tactics to the launch and execution of a planned Phase 2 study evaluating regulatory T cells for the treatment of type 1 diabetes and a planned Phase 1b/2a study in refractory asthma patients, both expected to launch in 2014," stated Dr. Douglas Losordo, Chief Medical Officer of NeoStem."NeoStem's cumulative manufacturing and clinical development experience gained over the past 15 years in collecting, storing, manufacturing and delivering viable, approved and experimental cell therapies for thousands of patients through its subsidiary Progenitor Cell Therapy, including that acquired through the manufacturing of Provenge® for prostate cancer from Phase 1b through Phase 3b (FDA approved in 2010), collectively demonstrates the Company's ability to efficiently develop, manufacture and distribute multiple commercially viable applied cell therapies for ourselves and our clients," said Dr. Andrew Pecora, Director and Chief Visionary Officer of NeoStem.