Healthcare Industry News:  protein replacement therapy 

Biopharmaceuticals Cardiology FDA

 News Release - July 13, 2006

CoGenesys Receives FDA Clearance to Commence Clinical Trials of Cardeva in Patients with Chronic Heart Failure

ROCKVILLE, Md., July 13 (HSMN NewsFeed) -- CoGenesys, Inc. announced today that the U.S. Food and Drug Administration has completed its review of the Company's Investigational New Drug (IND) application for Cardeva(TM), a long- acting form of b-type natriuretic peptide (BNP), and that the Company intends to begin clinical testing in the United States shortly, pending institutional review board approval. Cardeva is the most advanced compound in CoGenesys' broad pipeline of improved, long-acting biopharmaceuticals being developed to address unmet medical needs across a broad spectrum of therapeutic areas.

Preclinical studies have demonstrated that Cardeva, a human serum albumin (HSA)-BNP fusion protein, retains the pharmacological profile of BNP peptide but has a greatly extended half-life and long duration of action. The Phase I/II clinical trial of Cardeva will be a randomized, multicenter, double- blind, vehicle-controlled, ascending repeat dose safety and tolerability trial in up to 80 stable subjects with class II or III heart failure. Subjects will receive one or two doses of Cardeva. Evaluations will include safety and tolerability, pharmacokinetic profiles, and signals for effect.

"BNP stimulates cyclic GMP, which is not only a vasodilator but an inhibitor of the progressive heart muscle structural remodeling that leads to progression of heart failure," according to Jay N. Cohn, M.D., Professor of Medicine at the University of Minnesota. "Chronic administration of a long- acting BNP could have remarkably favorable effects that must be documented in clinical trials," he said.

Martha A. Reitman, M.D., CoGenesys' Senior Vice President, Medical Affairs, stated, "We are pleased to announce the initiation of the clinical program for Cardeva, which we believe holds great promise in the treatment of CHF. Heart failure patients with significant decompensation are currently only able to receive a short-acting BNP intravenously, usually in a hospital setting, to improve their clinical status. With Cardeva, our goal is to provide a low-dose, subcutaneous administration allowing for chronic outpatient treatment that will improve quality of life and decrease the incidence of acute decompensation and hospitalization."

About Heart Failure

In heart failure, the heart is not able to adequately deliver oxygen-rich blood to the body, and patients often feel short of breath and have difficulty performing routine tasks. Quality of life is severely compromised, and annual mortality rates can average 20% or more in severe cases. The complex etiology and pathophysiology of CHF currently requires the use of multiple therapeutic agents for optimal patient management.

In CHF, BNP is naturally produced by the failing heart in an attempt to compensate for reduced cardiac output, leading to improved delivery of oxygen through mechanisms including increased coronary vasodilation and inhibition of the renin-angiotensin-aldosterone system. Natriuretic peptides have proven effective treatments for acute heart failure in the hospital setting, however, their unfavorable pharmacokinetics has proved a substantial obstacle to development for outpatient treatment of CHF.

According to the American Heart Association, the prevalence of CHF in the U.S. during 2003 was approximately 5,000,000 patients. These patients are at significant risk for hospitalization, translating into a potential cost of $29.6 billion for the healthcare system. In 2003, there were approximately 550,000 new cases reported, and almost 57,000 attributable deaths. The number of CHF deaths has increased steadily despite advances in treatment, in part because of increasing numbers of patients with CHF due to better treatment and as a result of improved patient survival following acute myocardial infarctions early in life. More than 10 million patients will likely suffer from CHF by 2020, mainly as a result of aging in our society and advances in the treatment of other cardiovascular disorders.

Prognosis for CHF patients is poor with 12% mortality within three months of diagnosis and 33% by one year. Approximately 60% of patients with CHF die within five years of initial diagnosis, a mortality rate comparable to the worst forms of cancer.

About CoGenesys' Therapeutic Pipeline and Technology

Development programs at CoGenesys are capitalizing on the depth of its pipeline and the breadth of its technology to develop lead drug candidates addressing a broad spectrum of diseases and applications, including cardiovascular disease, diabetes/metabolism, enzyme and protein replacement therapy and others. CoGenesys' state-of-the-art research and manufacturing facility is fully equipped, supporting both preclinical development and cGMP manufacture of biologics.

The clinically validated albumin-fusion technology offers a number of advantages, including the ability to improve the bioavailability of existing biologicals, such as interferon alpha (being developed by Human Genome Sciences, Inc. (HGS) and Novartis), and increased feasibility of developing pharmaceutically relevant peptides, such as GLP-1 (being developed by GlaxoSmithKline under license from HGS). In addition to Cardeva, CoGenesys is readying for clinical development a second product, a long-acting form of Granulocyte Colony Stimulating Factor (GCSF), to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs.

About CoGenesys, Inc.

CoGenesys is advancing a pipeline of improved, long-acting biopharmaceuticals developed to address unmet medical needs across a broad spectrum of therapeutic areas. The Company's strategy is to demonstrate safety and proof of concept in clinical trials followed by licensing or partnering of compounds to fund further development. CoGenesys has approximately 70 employees, including 20 Ph.D.-level scientists, and a dedicated 48,000 sq. ft. facility with specialized laboratories and cGMP manufacturing capacity sufficient for early-stage clinical testing. For more information about CoGenesys visit us at our website

Source: CoGenesys

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