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Biotech / Medical : PRCS
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To: Witold who started this subject12/3/2001 9:16:13 AM
From: sim1   of 78
 
PRAECIS PHARMACEUTICALS INCORPORATED Announces
Plans To Proceed With The Development of Plenaxis(TM) for the
Treatment of Prostate Cancer

Meeting with FDA Leads to Next Clinical Studies

WALTHAM, Mass., Dec. 3 /PRNewswire/ -- PRAECIS PHARMACEUTICALS INCORPORATED (Nasdaq: PRCS - news), today announced that it discussed with representatives from the United States Food and Drug Administration (FDA) its plans to advance the development of Plenaxis(TM) (abarelix for injectable suspension) for the treatment of hormonally responsive advanced prostate cancer.

The Company is pleased to announce that following this discussion, the FDA indicated that the Company could proceed with its clinical plans to study the effects of using currently available hormonal therapies in prostate cancer patients following treatment with Plenaxis. The FDA also indicated that the Company's plan to further evaluate the rare allergic reactions that occurred in its clinical trials was acceptable. The Company intends to initiate clinical studies during the first quarter of 2002 and, assuming positive results, expects to submit the data from these studies to the FDA by the end of 2002 in an effort to gain marketing approval for Plenaxis for the treatment of hormonally responsive advanced prostate cancer....
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