NeoStem Closes Patient Enrollment In Phase 2 AMR-001 Trial - Quick Facts

(RTTNews) - NeoStem Inc. (NBS) announced that it completed 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 or STEMI.

With infusion of the target population of 160 patients complete, NeoStem expects data readout in the third quarter of 2014.

"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," said Douglas Losordo, Chief Medical Officer of NeoStem.

ST segment elevation myocardial infarction or 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.