Gensia Inc. said Monday a final analysis of last year's failed PhaseIII trials of Protara, combined with data from four other clinicalstudies, has uncovered signs of life for the drug, which wasdeveloped for treatment of heart attacks during bypass surgery.
Last October, San Diego-based Gensia stopped work on Protarawhen preliminary data from the Phase III trials demonstrated nostatistical significance, compared with a placebo, in preventingmyocardial infarctions in patients undergoing heart bypass surgery.
However, Gensia said that by pooling results of five clinical trials -involving 4,000 patients - in a "meta-analysis" of Protara's performance yields data that shows Protaraachieved statistical significance when combining the drug'sperformance in preventing heart attacks, strokes or cardiac deaths inbypass patients.
As a result of the analysis, Gensia's spokeswoman, Martha Hough,said the company is in discussions with several large pharmaceuticalfirms to take over development of Protara and to assist Gensia inmoving forward with other compounds based on the same adenosineregulating agent technology.
Gensia will release complete details of the Phase III Protara studyMay 8 at annual meeting of the Society of CardiovascularAnesthesiologists in Philadelphia.
In a prepared statement, Gensia's Chairman and CEO David Halesaid, "We believe that, when taken as a complete package, theProtara clinical data indicated that the drug has therapeutic activity inthe setting of coronary artery bypass graft surgery."
Last October, after Gensia discontinued its development of Protara,the company's stock (NASDAQ:GNSA) tumbled 51 percent. Sincethen Gensia has laid off 44 employees and announced a restructuringof its programs.
Gensia closed Monday at $2.69, unchanged. _ Charles Craig
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