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CoGenesys, Inc. Initiates Phase 1-2 Clinical Trial Of Cardeva In Patients With Heart Failure


10/11/2006 10:33:18 AM

ROCKVILLE, Md., Oct. 11 /PRNewswire/ -- CoGenesys, Inc. announced today the first patient dosing in the Phase 1-2 clinical trial of Cardeva(TM), a long-acting form of B-type natriuretic peptide (BNP) that is being developed for the treatment of patients with heart failure (HF). Cardeva is the most advanced compound in CoGenesys' broad pipeline of improved, long-acting biopharmaceuticals being developed to address unmet medical needs across a 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.

Drs. Horng Chen and John Burnett from the Mayo Clinic who performed some of the preclinical studies stated, "Cardeva represents a major advance in our efforts to more chronically activate the natriuretic peptide system in cardiovascular disease through renal and cardiovascular actions. This may be more important than ever as we have come to realize that the heart may release abnormal molecular forms of BNP with reduced biological activity in human heart failure. Cardeva may help correct this deficiency."

Martha A. Reitman, M.D., CoGenesys' Senior Vice President, Medical Affairs, stated, "We are pleased to announce the initiation of subject dosing in the Cardeva clinical program. Cardeva offers the potential for low-dose, subcutaneous administration, which would allow for chronic outpatient treatment to improve quality of life and decrease the incidence of acute decompensation and hospitalization. The primary focus of the clinical trial will be to evaluate the safety and tolerability of Cardeva. Secondary endpoints include the pharmacokinetic profile and measures of biological activity."

The Phase 1-2 clinical trial of Cardeva is 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 or vehicle control.

About Heart Failure

In heart failure (HF), 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 HF) currently requires the use of multiple therapeutic agents for optimal patient management.

In HF, 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 rennin-angiotensin-aldosterone system. Natriuretic peptides have proven effective treatments for acute HF in the hospital setting, however, their unfavorable pharmacokinetics has proved a substantial obstacle to development for outpatient treatment of HF.

According to the American Heart Association, the prevalence of HF 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 HF deaths has increased despite advances in treatment, in part because of increasing numbers of patients with HF due to better treatment and resulting from improved patient survival following acute myocardial infarctions early in life. More than 10 million patients will likely suffer from HF by 2020, mainly as a result of aging in our society and advances in the treatment of other cardiovascular disorders.

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

About CoGenesys, Inc.

CoGenesys, Inc. was spun out of Human Genome Sciences, Inc. in June of 2006. 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 PhD-level scientists, and a dedicated 48,000 sq. ft. facility with cGMP manufacturing capacity sufficient for early-stage clinical testing.

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 pre-clinical 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. (HGSI) 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 developing a long-acting form of Granulocyte Colony Stimulating Factor (GCSF), to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs, and Albulin-G, a long-acting form of insulin.

For more information about CoGenesys visit http://www.cogenesys.com . Contact: Mark A. Rampy, Ph.D. Chief Business Officer (240) 821-9019 mark_rampy@cogenesys.com

CoGenesys, Inc.

CONTACT: Mark A. Rampy, Ph.D., Chief Business Officer of CoGenesys, Inc.,+1-240-821-9019, or mark_rampy@cogenesys.com


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