Encouraging Phase III Results for ARCA Biopharma, Inc. (NASDAQ:ABIO) Print E-mail
By Michael Vlaicu   
Tuesday, 12 May 2009 07:18

Heart failure has always been one of the predominant fatal human conditions, today I focus on a company which has developed a treatment with encouraging results against this, often fatal, disease.

Key Facts: Heart failure becomes more common with increasing age. About 1 in 35 people aged 65-74 years have heart failure. This increases to about 1 in 15 of people aged 75-84 years, and to just over 1 in 7 people aged 85 years and above. It is uncommon in younger people.


It is difficult to give an outlook (prognosis) for an individual. In general, the more severe the heart failure, the worse the outlook. In many cases, the symptoms remain at a stable level for quite some time (months or years) before becomming worse. In some cases the severity and symptoms become gradually worse over time. Severe heart failure can lead to death.

In many cases, the symptoms of heart failure can be eased with treatment. Treatment not only eases symptoms but can improve prognosis and prolong life.

The broad world market for this drug is truly spectacular.

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About: ARCA biopharma, Inc. (NASDAQ:ABIO), formerly Nuvelo, Inc. is a biopharmaceutical company focused on developing genetically-targeted therapies for heart failure and other cardiovascular diseases. ARCA’s lead product candidate Gencaro (bucindolol hydrochloride), a beta-blocker and mild vasodilator is under review by the United States Food and

Drug Administration (FDA), for chronic heart failure (HF).

FDA News: Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09. ABIO also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ABIO has identified genetic traits which the Company believes will predict patient responses to the drug and

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hopes to launch both as a personalized medicine combination to optimize treatment outcomes.

Gencaro Positive Phase III Results: Arca biopharma reports overall survival benefit from heart failure trial. 92% of the projected primary endpoint events available. Arca biopharma has reported data from the pivotal Phase III Best trial of Gencaro in patients with advanced chronic heart failure. The trial results demonstrated that, in a demographically diverse group of primarily US patients with New York Heart Association class III and IV heart failure, Gencaro treatment resulted in a near significant overall survival benefit and
statistically significant benefits in slowing progression of heart failure.

All eight secondary endpoints of the trial were positive and statistically significant. As pre-specified with the FDA, the composite endpoint of heart failure progression was the most important secondary endpoint, with Gencaro shown to be superior to placebo for slowing progression of heart failure (HR 0.80, p=0.00003), and for the endpoint’s components of heart failure-related mortality (HR 0.85, p=0.042), heart failure-related hospital admission (HR 0.77, p=0.00002), and heart failure-related emergency room visits (HR 0.74, p=0.024).

 

This article was contributed to BioMedReports.com by Michael Vlaicu for publication.

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  Michael Vlaicu, Lead Investment Analyst at StocksHaven.com: A young yet experienced investments mogul, and accomplished day-trader since '01; Michael has amassed a fortune as a private self investor. Recently starting his own successful blog and turning it in to a self-proprietorship, StocksHaven Investments, a company offering advice to thousands of people worldwide and attracting contracts from various reputable sources. He has reached Expert Stock Analyst status from a variety of accredited publications.



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