PreSERVE AMI Data Readout Expected in Third Quarter 2014
New York, Dec. 16, 2013 — 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.
“The completion of the enrollment of the PreSERVE AMI Phase 2 clinical trial in 60 medical centers across the United States to treat an acute heart attack (STEMI) with a patient’s own adult stem cells derived from their bone marrow further validates our ability to progress logistically complex applied cell therapies through the development pipeline in acutely ill patients and is an infrastructure we will continue to utilize for our internal development,” said Dr. Robin L. Smith, Chairman and CEO of NeoStem.
ST segment elevation myocardial infarction (STEMI) is the most dangerous type of myocardial infarction (or heart attack) and is determined by an electrocardiogram test. In the United States, there are more than 160,000 patients per year who suffer a STEMI, resulting from a sudden blockage of one of the arteries that supplies nutrient-rich blood to the heart muscle. STEMI patients are at a high risk of a progressive deterioration in heart muscle function that leads to arrhythmia, revascularization procedures, recurrent myocardial infarction, left ventricular dysfunction, congestive heart failure and premature death. Treatment of these patients post-heart attack represents a significant financial burden for many managed care programs. We expect this burden will increase as the “baby boomer” population ages and the annual number of STEMI likely increases. AMR-001, if approved, could provide a significant pharmacoeconomic benefit by preventing downstream cardiac adverse events.