BOSTON--(BUSINESS WIRE)--Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative mitochondrial therapies for diseases with unmet medical needs, presented its lead clinical candidate, Bendavia™, during the 2011 American Heart Association’s (AHA) Cardiovascular Scientific Sessions. Bendavia is a novel compound that targets the mitochondrion to treat mitochondrial dysfunction including ischemia reperfusion and microvascular injuries. AHA is a U.S. non–profit organization that focuses on cardiac care worldwide with a goal of reducing morbidity and mortality caused by cardiovascular disease, the leading cause of death worldwide. The 2011 AHA Cardiovascular Scientific Sessions were held July 18th through 21st, in New Orleans, Louisiana, and centered on state–of–the art scientific advances for cardiovascular medicine and biology.
Dr. Peter Rabinovitch, University of Washington, first introduced Bendavia during the Longevity and Caloric Restriction Session demonstrating its potential as a therapy for cardiac hypertrophy and heart failure within several cardiovascular animal models. Later, Dr. Robert Kloner’s laboratory, led by Sharon Hale, Heart Institute of Good Samaritan Hospital, presented animal data on Bendavia for acute myocardial infarction (AMI) and its ability to preserve viable and compromised myocardium after ischemia reperfusion injury, while independently reducing the area of microvascular dysfunction associated with the often termed “no–reflow” phenomenon. The no–reflow phenomenon was originally described by Dr. Kloner more than three decades ago and more recently has been shown to be an independent determinant of mortality and morbidity for AMI patients.
The initial clinical program for Bendavia is the treatment of ischemia reperfusion and microvascular injuries, common complications of interventional procedures for AMI, coronary bypass surgery and renal transplantation. Standard animal models for such interventional procedures including those presented by Dr. Kloner’s laboratory demonstrate Bendavia’s beneficial biologic effects and confirm the significance of its novel mechanism of action, which preserves mitochondrial function under pathological conditions, for ischemia reperfusion and microvascular injuries.
Contrary to prior therapeutic strategies for ischemia reperfusion injury and AMI that focused on uni–targeted pathways, Bendavia and its mitochondria–directed actions address the more complicated, multifactorial nature of diseases. Specifically, Bendavia appears to maintain electron transport chain efficiencies under substantial oxidative stress, thereby preserving mitochondrial respiration and adenosine triphosphate levels and preventing mitochondrial swelling and depolarization. Bendavia also appears to be a strong neurologic and renal protectant in preclinical models, which holds promise as a treatment for stroke and renally impaired patients.
Stealth’s CEO, Travis Wilson, remarked, “Stealth is enthusiastic about the recognition of Bendavia as a novel candidate for such common cardiovascular diseases as AMI and heart failure. Based on the successful conclusion of our Phase I clinical trials and encouraging preclinical data for several chronic and acute conditions, we feel that Bendavia has the potential to be a significant advancement to the treatment of cardio–renal, neurologic and metabolic disorders including rare and orphan related diseases.”
Stealth is currently initiating a multinational Phase II clinical study with Bendavia focused on ischemia reperfusion injury for patients experiencing acute ST–segment elevation myocardial infarction (STEMI). Stealth’s Phase II clinical trial is termed EMBRACE–STEMI™ for the Evaluation of the Myocardial effects of Bendavia for reducing Reperfusion injury in patients with Acute Coronary Events.
More information regarding Stealth and its development programs for Bendavia is available at www.stealthpeptides.com.
About Acute Myocardial Infarction
Statistics from the AHA indicate that more than 600,000 people within the U.S. die from heart disease and AMI each year, an amount greater than the combined total of mortalities from every type of cancer. As background, ischemia is defined as the inadequate supply of oxygen and nutrients to maintain normal cellular aerobic metabolism. It arises primarily from a lack of blood flow to tissue and is seen in a variety of clinical conditions including stroke, AMI, acute and chronic kidney injury and organ transplantation. In tissues with high metabolic activity, such as the brain and heart, adenosine triphosphate stores are depleted within the first few minutes of ischemia. 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, which is a major determinant of mortality and morbidity for AMI patients. Paradoxically, the return of blood flow after ischemia can also result in additional cardiac damage and complications. This phenomenon known 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 and complications including heart failure. To date, effective therapies to reduce or prevent reperfusion injury have proven elusive. Through its mitochondria–directed actions, Bendavia appears to be a lead candidate for innovative pharmacologic approaches to reduce ischemia reperfusion and microvascular injuries in patients.
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 disorders. The intellectual property portfolio around these compounds is exceptionally robust with compositions, including Bendavia, protectable by patent until 2031.
More information regarding Stealth and its pipeline is available at www.stealthpeptides.com.