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Medical stock spotlight: ARCA Biopharma Inc.

Medical Stock Spotlight: ARCA Biopharma Inc. (Nasdaq) led advancing issues, more than tripling over the week to $8.22. The company was issued a U.S. patent on methods of treating heart failure patients with bucindolol hydrochloride "C" tradenamed Gencaro--based on genetic testing. On March 25, ARCA followed-up the patent issuance with submission of a revised clinical study protocol for review under the FDA's Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. If ARCA obtains sufficient funding and FDA approval of the SPA, ARCA expects it could begin the proposed clinical trial approximately one year after such funding and approval. The FDA has previously designated as a "fast track" development program the investigation of Gencaro for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population.

Elsewhere, World Heart Corp. (Nasdaq) more than doubled on the week to $2.87 after the company said its magnetically levitated heart pump was successfully implanted at the University of Utah hospital. The company said that the Salt Lake City, Utah hospital was the second implanting site nationwide in a study that was testing the heart pump in patients with severely damaged hearts who need the help of an artificial heart pump while waiting for a transplant. It was the fourth implant with the Levacor Ventricular Assist Device since the inception of the study, the company said in a statement. In August last year, World Heart received a conditional approval from the FDA to begin a clinical study of its Levacor device.

Gentium SpA (Nasdaq) surged 75 cents, or 35%, to $2.89 after the Italian company reported promising data from a study on its experimental drug to treat the blockage of small veins in the liver. The biopharmaceutical firm was testing the use of the drug, defibrotide, for preventing veno-occlusive disease (VOD) in pediatric patients who were at high risk. VOD is a potentially life-threatening condition that typically occurs as a complication of stem cell transplantation. The company said defibrotide showed a 40% reduction in the incidence of VOD within 30 days after stem-cell transplantation, the primary endpoint of the Phase II/III study. The drug was well tolerated in the study, it added.

And China Biologic Products Inc. (Nasdaq) leaped $2.34, or 26%, to $11.50. The company reported fourth-quarter earnings-per-share of $0.44, versus $0.15 reported for the same period a year ago. Revenue for the quarter was $37.6 million, compared to $13.76 million in the year-ago quarter. China Biologic is engaged in the research, development and manufacturing of plasma-based pharmaceutical products in China. Its Taibang unit operates from its manufacturing facility located in Taian City, Shandong Province. The company's principal products include its approved human albumin and immunoglobulin products.

But ChemGenex Pharmaceuticals Ltd. (Nasdaq) plunged $3.50, or 35%, to $6.50--the most in 16 years--after the FDA said it wants to see more clinical test data before reviewing the company's leukemia drug. Outside advisers to FDA voted 7-1 last week that the agency should require a uniform test to ensure the Australian drugmaker's Omapro is only used for patients with a genetic resistance to Novartis AG's Gleevec. While the FDA usually follows its advisory committees' recommendations, it isn't required to do so. ChemGenex has been working with the FDA on the diagnostic matter and will meet with the agency on April 9 to review its strategy for having Omapro approved.

And Oncothyreon Inc. (Nasdaq) skidded 75 cents, or 27%, to $3.42. The clinical-stage biotechnology company said its partner Merck Serono temporarily suspended all clinical trials of the drug candidate Stimuvax because of potential safety issues. Stimuvax is Oncothyreon's lead drug candidate and the company does not have a product on the market. Merck Serono is part of Germany-based Merck KGaA. The company said the suspension was the result of a "suspected unexpected serious adverse reaction" in a multiple myeloma patient. Specifically, the patient in a small exploratory study receiving an intensive regimen of the drug developed an inflammation of the brain.
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Title Annotation:TOP STORIES
Publication:MondayMorning
Geographic Code:1USA
Date:Mar 29, 2010
Words:704
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