Senetek PLC - SNTKY Breaks out to new high Message Board

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Microcap & Penny Stocks : Senetek PLC - SNTKY Breaks out to new high

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To: J. Kittle who wrote ()	8/13/1999 6:44:00 PM
From: SemiBull	Read Replies (1) of 737

Senetek Reports on MCA and FDA Reaction to Preliminary Findings Of Phentolamine Mesylate Study Underway by Another Company Mutual Recognition Process to Register Invicorp(TM) in European Union Remains Ongoing and Has Not Been Impacted by Clinical Hold NAPA, Calif., Aug. 13 /PRNewswire/ -- Senetek PLC (Nasdaq: SNTKY - news) today announced that the United Kingdom's Medicines Control Agency (MCA) was notified by the United States' Food and Drug Administration (FDA) of safety concerns regarding a competitor's product undergoing testing in the U.S., and as a result, until the implications of the new findings have been evaluated, it is prudent to place a temporary hold on all clinical trials that may be implicated. For reasons of commercial confidentiality, the MCA is unable to provide details of the evidence which is currently being assessed and analyzed. Senetek has no clinical studies underway or planned at this time. In addition, the FDA's Division of Reproductive and Urologic Drug Products notified Senetek that preclinical findings of tumors have been reported from a competitor's carcinogenity studies concerning phentolamine mesylate, an ingredient found in low concentrations in Senetek's Invicorp(TM) product. Additional information and final conclusions are pending regarding these preclinical findings. Following receipt of the complete response to these issues, the FDA will notify Senetek of their decision regarding phentolamine mesylate within thirty days. The activities to support the Mutual Recognition Process to register Invicorp(TM) in the European Union are ongoing and have not been impacted by the clinical hold. Senetek PLC is a science-driven biotechnology company providing solutions to aging-related healthcare problems, in the form of biopharmaceuticals, drug delivery systems and skincare. The Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995. This press release contains forward-looking statements that involve risks and uncertainties including the risks detailed from time to time in the Company's Securities and Exchange Commission filings. SOURCE: Senetek PLC

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