Nile Therapeutics : Fast Track Designation for Cenderitide for Post-Acute Indication

March 31, 2011 -- Nile Therapeutics, Inc. (NASDAQ: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Nile's post-acute development program for cenderitide, which has the goal of reducing cardiovascular mortality and cardiovascular re-hospitalization in the post-acute period in patients with acute decompensated heart failure.

As previously announced, Nile plans to develop cenderitide as an outpatient therapy to be delivered to acutely decompensated heart failure (ADHF) patients continuously for up to 90 days after discharge from the hospital. This is a novel therapeutic indication that is being referred to as "post-acute."

"We are very pleased that the FDA has recognized cenderitide's potential to address an important unmet medical need for heart failure patients," said Joshua Kazam, Nile's Chief Executive Officer. "If our post-acute cenderitide program is successful, then we may be able to reduce the annual number of hospital visits for ADHF, potentially saving the health care system billions of dollars."... Nile Therapeutics' Press Release -

Stealth Peptides : Results from Healthy Volunteers Phase I Clinical Study with Bendavia™

April 4, 2011 – Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative therapies, announced the results of a healthy volunteers Phase I clinical study of Bendavia™, a novel compound that targets the mitochondrion to treat ischemia reperfusion injury. This study evaluated healthy male and female volunteers representing a broad range of adult ages. During the study, volunteers received a single dose of Bendavia administered as an intravenous infusion over an extended period. Safety data from the clinical trial and preliminary results demonstrate that Bendavia appears to be safe and well–tolerated at the dose evaluated, with no serious adverse events reported. Pharmacokinetic analysis from related clinical studies also showed highly predictable dose–proportional exposure of Bendavia among volunteers.

The initial clinical program for Bendavia is the treatment of ischemia reperfusion injury, a common complication of interventional procedures for acute myocardial infarction (AMI) and coronary bypass surgery. Standard animal models for AMI demonstrate Bendavia’s beneficial myocardial effects and confirm the significance of its novel mechanism of action, which preserves mitochondrial function under pathological conditions, for ischemia reperfusion injury.

Contrary to prior therapeutic strategies for ischemia reperfusion injury and AMI that focused on uni–targeted pathways, Bendavia and its mitochondrial directed actions address the more complicated, multifactorial nature of diseases. Specifically, Bendavia has been shown to improve electron transport efficiency, maintain mitochondrial respiration and adenosine triphosphate levels and prevent mitochondrial swelling and depolarization. Bendavia also appears to be a strong neurologic protectant, which holds promise as a treatment for cardiac arrest and stroke patients... Stealth Peptides' Press Release -

Critical Diagnostics : ST2 Predicts Outcomes and Cardiac Function After Chest Pain and Myocardial Infarction and in Advanced Heart Failure

April 1, 2011 - Three Clinical Studies at the American College of Cardiology Examine the Presage® ST2 Assay Across Clinical Presentations and Progression to Advanced Cardiovascular Disease - A novel cardiac biomarker, ST2, will be highlighted in three presentations at the American College of Cardiology (ACC) in New Orleans this week. These studies and others have demonstrated that a patient's ST2 level can help a physician better predict prognosis, change in cardiac status, and development of cardiovascular complications such as heart failure, at critical clinical decision points, including at initial presentation with chest pain, after recovery from myocardial infarction, and in the cardiac intensive care unit.

"We continue to find that ST2 is a valuable prognostic tool in assessing patients across various stages of cardiovascular disease," said Dr. James L. Januzzi, the Director of the Cardiac Intensive Care Unit at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School. "In our recent study in Advanced Stage Heart Failure Patients, we concluded that measurement of ST2 may help us determine appropriate courses of action in these late-stage patients."...

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..."We are pleased to see the research community continue to generate strong evidence that ST2 predicts outcomes for cardiovascular patients," said James Snider, President of Critical Diagnostics. "The studies presented here show that ST2 can be a valuable tool for clinicians across the spectrum of heart failure: from predicting onset to predicting outcomes in late-stage patients. These clinical data continue to build evidence that ST2 may help aid physicians in clinical decision-making."... Critical Diagnostics' Press Release -