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HaptoGuard Files Investigational New Drug Application for BXT-51072 to Treat Diabetic Patients at High Risk for Cardiovascular Complications

Posted on: Monday, 22 August 2005, 09:00 CDT

FORT LEE, N.J., Aug. 22 /PRNewswire/ -- HaptoGuard, Inc. announced today that it has filed an Investigational New Drug (IND) application with the Division of Cardio-Renal Drug Products of the U.S. Food and Drug Administration for BXT-51072, an oral, organoselenium compound that exhibits potent anti-inflammatory features, by mimicking glutathione peroxidase (GPx). Because Phase I safety studies were previously performed by Oxis International under an IND in the Division of Gastrointestinal and Coagulation Drug Products, this new IND contemplates the immediate performance of Phase II clinical trials for cardiovascular indications. As a mimic of GPx, BXT-51072 may protect against excessive oxidation of lipids and thereby limit inflammation. The Company believes that BXT-51072 may be useful in many or all patients with diabetes, whose cardiovascular disease may be caused in large part by high levels of circulating oxidized-lipids and associated inflammation.

"This IND for BXT-51072 represents a significant step forward in our determined effort to develop a novel and much needed therapy for the diabetic community," said Noah Berkowitz chairman and chief executive officer of HaptoGuard. "Our plan is to initiate our Phase II program shortly after our IND is approved."

HaptoGuard's development strategy for BXT-51072, a rapidly absorbed, oral drug, relies in part on identifying a high risk patient population for inclusion in its clinical trials. The Company anticipates using its proprietary, rapid, haptoglobin genotyping assay, which identifies a subset of diabetic patients (40%) who appear to have higher levels of oxidized lipids, more inflammation and more severe cardiovascular complications. Pre-clinical data suggests that BXT-51072 may be protective by retarding this inflammation. This pharmacogenomic strategy drives, what may be, a shorter, less expensive path to drug approval

About BXT-51072

BXT-51072 was previously studied by Oxis International in a Phase II clinical trial for patients with ulcerative colitis, where the drug was well tolerated and demonstrated some indications of efficacy. The potential use of this drug in cardiovascular indications has generated intense enthusiasm because glutathione peroxidase, the naturally occurring enzyme whose function is mimicked by the drug, has been convincingly associated, epidemiologically, with myocardial protection in human clinical trials and because use of the drug in an animal model of myocardial protection revealed convincing results. This oral drug metabolizes toxic, oxidized fats found in blood vessels and heart muscle of diabetic patients and may shut down the inflammatory machinery that induces a staggeringly high rate of heart failure and death in these patients following a heart attack.

About HaptoGuard, Inc.

HaptoGuard, Inc., a privately-held biopharmaceutical company headquartered in New Jersey, is developing anti-inflammatory drugs. Its lead program targets patients with diabetic cardiovascular disease. Diabetics have a profound increase in risk of death and heart failure following acute myocardial infarction. Current therapies fail to reduce that risk satisfactorily. BXT-51072 is being developed to target these high risk patients.

HaptoGuard, Inc.

CONTACT: Noah Berkowitz of HaptoGuard, Inc., +1-201-947-1270; CarneyDuntsch of Burns McClellan, Inc., +1-212-213-0006, for HaptoGuard, Inc.

Source: PRNewswire

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