Gensia Inc.'s stock fell as much as 35 percent Friday, onlyto fight its way back by the time the market closed,reflecting, in part, an uncertainty that swept investors as thecompany announced that Phase III trials of its lead drug,Protara, were stopped.San Diego-based Gensia said an independent safety anddata monitoring panel conducting an interim analysis of thetrials recommended termination of the studies. The panelsaid safety was not a factor. But it released no otherinformation on its findings of how Protara performed inpreventing myocardial infarction in patients undergoingcoronary bypass surgery.Gensia's researchers and clinical investigators are blindedto the results, so the panel's action could mean the interimdata either showed Protara achieved a statisticallysignificant reduction in heart attacks or it did not.The open-ended patient enrollment studies are the thirdPhase III trials of Protara for myocardial infarction andother adverse cardiac events associated with heart surgery.Brandon Fradd, of Montgomery Securities in SanFrancisco, said "the panel has seen something important,"but Gensia won't know what it is until it can analyze thedata.Uncertainty about the interim analysis apparently wasn'tthe only variable involved in sending Gensia's stock down$3.50 a share Friday before it rallied. The stock regained $3and closed at $9.50, down 50 cents. More than 2.3 millionshares were traded.Some analysts blamed a misleading Dow Jones NewsService headline, released at about 2:50 p.m. EST, for thetemporary drop. The news service, after getting calls aboutthe headline, agreed it was less than accurate and tried tocorrect it. The misleading version read, "Gensia Says PanelAdvises It To End Study."Analysts observed that at a time when the biotechnologyindustry has experienced more failures than successes anews alert that an on-going clinical trial was ended tends tocarry a negative connotation.Carol Werther, an analyst with Cowen & Co. in Boston,said her first reaction was negative. But then she realizedthe company's announcement also could be positive."They either have a statistically significant result or it isn'tstatistically significant," she said. "Even though thevaluation on the company is low, it isn't worth buying ituntil we get the results [of the interim analysis]. But I alsowouldn't sell."In a prepared statement, Gensia's Chairman David Halesaid analysis of the data won't be complete for about 10weeks. He added that if the results are favorable, "we planto submit these data, which would provide further supportfor the efficacy of Protara, to regulatory authorities in thefourth quarter of 1994."Elizabeth Foster, Gensia's director of corporatecommunications, said the company will analyze data from2,500 patients included in the independent panel's interimreview and another 200 patients who were enrolled in thetrials while the panel conducted its analysis.Protara is administered to patients for seven hours prior tosurgery and through recovery and is designed to promotedelivery of oxygen to heart muscle tissue throughregulation of the release of adenosine, which dilates theblood vessels.Gensia filed a new drug application for Protara inDecember 1992, following two Phase III trials, whoseresults, released in September 1993, were mixed.In a U.S. study, Protara showed a statistically significantreduction in heart attacks. However, an international trialwas not as successful. The current Phase III trial is asupplementary study to try to confirm the results of theU.S. trial. n
-- Charles Craig
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