Gensia Inc. said Wednesday that FDA has requested the resultsof the company's ongoing study of Protara (formerly Arasine)before considering the drug for approval.
The company submitted a new drug application (NDA) forProtara in December 1992 for the prevention of myocardialinfarction and other adverse cardiovascular outcomes inpatients undergoing coronary artery bypass graft surgery.
David Hale, Gensia's chairman, president and chief executiveofficer, told BioWorld that FDA's request for the additional trialdata was expected. The trial was initiated in February 1993 toprovide additional efficacy data in patients undergoingcoronary artery bypass surgery. It is expected to be completedin the first half of 1994.
Arasine is administered to patients during a seven-hour periodthat starts just prior to surgery and continues through therecovery period. The synthetically manufactured drug isbelieved to promote delivery of oxygen to heart muscle tissuethrough its regulation of the release of adenosine.
Hale said Gensia changed the name of the drug to Protara inNovember to avoid confusion with Merck's drug Aramine.
Gensia (NASDAQ:GNSA) of San Diego also announced that it hasbegun a Phase III study of Protara for an additional indicationto treat patients undergoing major non-cardiac surgery whoare at high risk of developing adverse cardiovascularcomplications. The study is expected to include 3,000 to 4,000patients at 75 centers in the U.S., Canada and Western Europe.Gensia said the trial will analyze the effects of Protara onreducing myocardial infarction, stroke and cardiac death.
Separately, Gensia announced that it is beginning a Phase I trialof GP-1-668, a second-generation adenosine regulating agent(ARA) for potential use in unstable angina, acute myocardialinfarction and/or prevention of adverse cardiovascularoutcomes associated with major non-cardiac surgery. The trialis being conducted in the United Kingdom.
This is the first ARA compound to be developed under Gensia's1991 research agreement with Aramed Inc. Under theagreement, Gensia is conducting research and development ofARAs in three treatment areas: acute cardiovascular, strokeand epilepsy. Hale said Gensia expects to have additional ARAsin clinical trials during 1994.
-- Brenda Sandburg News Editor
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