Gensia Pharmaceuticals Inc. soared $12.50 on Thursday onpublication of results from Phase II testing of Arasine,indicating that the cardiovascular drug significantly decreasedsigns of heart muscle injury during bypass surgery.
The stock (NASDAQ:GNSA) closed at $62 on trading of 17.9million shares.
The data, to be presented at the April meeting of the AmericanCollege of Cardiology, showed that bypass patients using thedrug had a statistically significant 38 percent reduction inlevels of the injury marker called CPK-MB, compared with aplacebo group.
The company termed "clinically important," but not statisticallysignificant, the 64 percent reduction of heart attacks in theArasine patients because only 116 patients were tested in thestudy.
Heart attacks severe enough to reach through the heart wallwill show up on an electrocardiogram, but more subtle damageis revealed by CPK-MB. Gensia spokeswoman Martha Houghsaid that bypass surgeons are beginning to use the CPK-MBmarker, and realize that the more subtle type of heart attack ismore common during bypass than previously thought. ECG-readable heart attacks occur in 5 percent to 20 percent ofbypass patients, she said.
The results were published in an abstract appearing in theJournal of the American College of Cardiology. The companyplans to present at the April meeting in Dallas additional dataon Arasine's effects in limiting perioperative myocardialischemia in bypass patients.
One thousand patients have already been enrolled in Phase IIItesting, with completion expected by April. The San Diegocompany expects to file for marketing approval in September.European filings are expected in the fourth quarter.
Hough said the company also plans Phase III testing of thedrug in heart patients undergoing other high-risk vascularsurgeries.
-- Roberta Friedman, Ph.D. Special to BioWorld
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