Gensia Inc.'s stock continued fluctuating based on speculation aboutthe conclusion of Phase III trials for its lead product, Protara, but unlikeFriday, the price Monday at the close of trading was higher by 29percent.Analysts with Hambrecht & Quist Inc., of New York, were amongthose generating investor support for Gensia (NASDAQ:GNSA),despite uncertainty about an independent safety and data monitoringpanel's recommendation Friday that Gensia stop its clinical trials ofProtara for myocardial infarction during heart surgery.In raising its rating from hold to buy Monday, D. Larry Smith,Hambrecht's managing director of research, said his company isspeculating the open-ended enrollment trials were stopped at 2,700patients because the results are positive.However, Matthew Geller, of Oppenheimer & Co., of New York, isn'tas optimistic. He said he believes the panel's interim analysis revealednegative results.Those betting on the success of the trials led Monday's rally as Gensiaclosed at $12.25 per share, up $2.75, or 29 percent.When Gensia announced Friday it was stopping the Phase III trials, thestock dropped as much as $3.50 a share, or 35 percent, but regained $3to close at $9.50, down 50 cents, or 5 percent.In recommending an end to the Phase III trials, the panel said safetywas not a factor, but it released no other information. That means thepanel has concluded the drug either succeeded or failed to showstatistical significance in preventing heart attacks in patientsundergoing coronary bypass surgery.Gensia said its researchers, who are blinded to the interim results,won't know the outcome until they analyze the data from those 2,500patients plus another 200 enrolled during the panel's review. Theanalysis is expected within the next 10 weeks.The study was the third Phase III trial and patient enrollment wasprojected as high as 4,500. It was conducted to confirm the company'sfirst Phase III trial, a U.S. study, which showed statistical significancein preventing heart attacks. A second, international study was not assuccessful.Smith said Hambrecht & Quist based their rating upgrade on the factthe drug has shown biological activity in past trials, that safety was notinvolved in concluding the study and that Gensia was prepared toenroll 4,500 patients.But Geller said concluding the trial early suggests the drug failed. Thepercentage of heart surgery patients suffering myocardial infarction isso small, he observed, that enrolling more patients, as Gensia hadplanned, would strengthen chances of showing efficacy.In addition, Geller said, preventing heart attacks during bypass surgery"doesn't have any clinical significance" as an endpoint. Myocardialinfarctions aren't necessarily fatal. If the drug showed effectiveness inpreventing death, he said, it would have a better chance of commercialsuccess."The drug is unlikely to get approved by the FDA and if it does getapproved it's unlikely to be used by doctors," Geller said.n
-- Charles Craig
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