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| |  Vasomax Phase III Clinical Trials Commences THE WOODLANDS, Texas—Nov. 6, 1996 -- Zonagen Inc. (NASDAQ: ZONA; Pacific: ZNG) today announced it has commenced the first of two U.S. Phase III clinical trials for Vasomax, the company's "on-demand" oral therapeutic for male impotency. The announcement was made by Joseph Podolski, president and chief executive officer of Zonagen. Podolski noted that this trial is the first of two pivotal U.S. trials. The second Phase III clinical trial is expected to begin later this month. In the trial just started, 360 patients have been enrolled at 14 sites. The second trial is expected to enroll some 540 patients at 20 sites. The trials are being conducted by Zonagen in connection with Affiliated Research Centers, and PPD-Pharmaco is monitoring the study. The company hopes to submit the results of these clinical trials to the FDA in June of 1997 as part of an NDA application. Podolski added that the Mexican Phase III trial of 165 patients has been completed and that all case report files are in. Once the data have been analyzed, the company expects to report the results of this trial. "To date, our continued clinical success of Vasomax supports our belief that it may provide a cost-effective, user-friendly therapy for approximately 40 to 50 percent of all impotent men. Particular attention has been placed on both side effect profiles as well as overall sexual experience. Our interim analysis of the Mexican data demonstrated that the drug appeared to be well tolerated, with no incidence of hypotension or fainting," said Podolski. Vasomax is formulated in a proprietary, fast-dissolving oral tablet yielding a plasma concentration of phentolamine, its active ingredient. Zonagen has received a domestic patent and has filed international patent applications on the Vasomax formulation. In addition to the company's continuing clinical trials with respect to Vasomax, Podolski added that Zonagen is in discussions with a number of pharmaceutical companies who have expressed interest in future marketing rights to Vasomax. Individuals who wish to participate in any of the Zonagen clinical trials may contact Julie Ross, at Affiliated Research Centers, 847/855-9595. Zonagen's strategy is to provide a complete line of products and services for the management of reproductive health. Any statements which are not historical facts contained in this release are forward looking statements that involve risks and uncertainties, including but not limited to those relating to the uncertainty of necessary financing, risks in product and technolgy development, government regulation, the ability to complete transaction, market acceptance and product demand, competition and other risks, identifed in the company's Securities and Exchange Commission filings.
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