Stealth Peptides Inc. Announces Clinical Phase I Results With Bendavia Demonstrating Safety And Tolerability With Highly Predictable Pharmacokinetics
BOSTON--(BUSINESS WIRE)--Sep 13, 2010 - Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative therapies, announced today the results of its first–in–humans Phase I clinical trial of Bendavia™, a new chemical entity that targets mitochondria to treat ischemia reperfusion injury. This double–blind, placebo–controlled, randomized study evaluated healthy male and female volunteers representing a broad range of adult ages. During the study, volunteers received one of five ascending doses of Bendavia or placebo administered as an intravenous infusion over a four hour period. An independent Safety Review Board closely reviewed all of the safety data from the clinical trial and preliminary results demonstrate that Bendavia appears to be safe and well–tolerated at the doses evaluated, with no serious adverse events reported. Pharmacokinetic analysis from the study also showed highly predictable dose–proportional exposure of Bendavia over a span of plasma levels that included doses exceeding the expected patient dose by several fold.
The initial clinical indication for Bendavia is the treatment of ischemia reperfusion injury, a common complication of interventional procedures for acute myocardial infarction (AMI). Standard animal models for AMI clearly demonstrate Bendavia's beneficial cardioprotective effects and confirm the significance of the compound's novel target, the mitochondrion, for ischemia reperfusion injury. Bendavia also appears to be a strong renal protectant, which may potentially curtail many of the renal complications seen in AMI patients.
Dr. Richard Straube, Stealth's CMO, commented, “We are very pleased with the Phase I data and tolerability of Bendavia across the doses examined. The achieved plasma levels are also predictable and consistent with those seen to be effective for significantly reducing infarct sizes in each of our AMI animal models.”
Stealth's CEO, Travis Wilson, further noted the importance of this successful Phase I trial, “Based on our clinical results and encouraging preclinical data for both AMI and other indications, we feel that Bendavia has the potential to be a paradigm shifting therapy for mitochondrial dysfunction, which is closely linked to many metabolic, ophthalmologic, neurologic and cardio–renal related diseases.”
Stealth is initiating a multinational Phase II trial with Bendavia focused on ischemia reperfusion injury in patients experiencing acute ST–segment elevation myocardial infarction (STEMI). The Phase II trial is termed EMBRACE–STEMI™ for the Evaluation of the Myocardial effects of Bendavia for reducing Reperfusion injury in patients with Acute Coronary Events. Stealth also looks forward to pursuing other opportunities and partnerships to develop Bendavia for indications beyond AMI, including those of significant unmet medical need that could dramatically benefit from a mitochondrial targeted therapy.
More information regarding Stealth and its development programs for Bendavia is available at www.stealthpeptides.com.
About Acute Myocardial Infarction
Statistics from the American Heart Association indicate that more than 600,000 people within the US die from heart disease and AMI each year, which is greater than the combined total from all cancers. Standard–of–care reperfusion therapies for AMI include primary percutaneous coronary intervention and thrombolysis. Prompt restoration of blood flow to the ischemic myocardium limits infarct size and the degree of infarcted myocardial tissue is a major determinant of mortality and morbidity with AMI. Paradoxically, the return of blood flow after ischemia can also result in additional cardiac damage and complications. This phenomenon, which is referred to as reperfusion injury, is associated with an array of myocardial, vascular and electrophysiological derangements that can increase infarct size and cause long–term clinical deterioration including heart failure. To date, effective therapies to reduce or prevent reperfusion injury have proven elusive. Bendavia™, through its mitochondrial directed actions, appears to be a lead candidate for innovative pharmacologic approaches to reduce ischemia reperfusion injury in patients. Across several standard AMI models, including large animal models, Bendavia has demonstrated the ability to consistently reduce infarct sizes by more than –35% when administered prior to the onset of reperfusion.
About Stealth Peptides
Stealth has a rich and promising pipeline of preclinical and clinical compounds from a unique class of short peptides (500–700 Daltons each) that target mitochondria. Published, peer–reviewed data for these compounds suggest significant in vitro and in vivo efficacy for metabolic, ophthalmologic, neurologic and cardio–renal related diseases. The intellectual property portfolio around these compounds is exceptionally robust with compositions, including Bendavia™, protectable by patent until at least 2026.
More information regarding Stealth and its pipeline is available at www.stealthpeptides.com.
Contact: Stealth Peptides Inc.
Travis Wilson, 617-244-2800
Posted: September 2010