La gross Tuna, do you remember the following comment you made concerning Zonagen a couple days ago concerning testing of their Vasomax product?
<<The studies you quote I haven't read but I am fairly confident they are a fraud like Bre-X mines.>>
Thought you might like to see the following which just came off the wire within the past hour. Apparently the fraud continues, n'est pas? ;-)
Just your friendly lay person,
Anaxagoras
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THE WOODLANDS, Texas, May 27 /PRNewswire/ -- Zonagen, Inc. (Nasdaq: ZONA; Pacific Stock Exchange: ZNG) today announced positive results of a Phase III clinical trial for Vasomax, its oral on-demand therapeutic for the treatment of erectile dysfunction.
Conducted at 20 centers including 435 men across the United States, candidates were selected from a broad patient population (including diabetics and men currently receiving cardiovascular therapy) having a history of erectile dysfunction for at least six months. Men having a history of radical prostectomy or spinal cord injury were intentionally excluded from the trial. The average age of men in the study was 59 years.
The study was designed to test the safety of both a 40 mg dose and 80 mg dose and to test efficacy using the Erectile Function Domain from the International Index of Erectile Function Questionnaire as the primary endpoint. The double blind placebo controlled study yielded a statistically significant improvement over placebo (p<0.001) with 40% of the men responding to the 40 mg dose compared to 17% responding to placebo. As in previous studies, side effects at the target 40 mg dose were mild. Side effects increased at 80 mg but remained within expectations.
"This data, the first of two pivotal U.S. trials of Vasomax, reaffirms our beliefs regarding the prospects of Vasomax to provide a user friendly therapy for erectile dysfunction," said Joe Podolski, President and Chief Executive Officer of Zonagen, Inc. "Once the data from the second trial has been analyzed, we will promptly report its results. Following the conclusion of the analysis from the second trial, we at Zonagen, with the aid of our consultants, should have a solid understanding of the overall benefits that this therapy can provide."
Mr. Podolski continued, "The Company plans to submit an NDA to the FDA as soon as practical. Simultaneously, we will use this data in negotiations of a possible agreement for global marketing arrangements with several major pharmaceutical companies. These results are obviously not only a further step in the development of Vasomax, but also an important milestone in the corporate development of Zonagen."
Zonagen, Inc. specializes in products and services for the management of reproductive health. Their technologies focus on the three areas of urology, female health and contraception. Through its wholly owned subsidiary, Fertility Technologies, Inc. (FTI), Zonagen sells devices, instruments and supplies to the fertility specialist and the OB/GYN. In addition to Vasomax(TM), the Company is currently developing novel fertility diagnostics and therapeutics, contraceptives and new therapeutics for benign prostatic hyperplasia, sexually transmitted diseases and prostate cancer.
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 technology development, early stage of product development, governmental regulation, risks associated with collaborative arrangements and the ability to complete transactions, market acceptance, dependence on third parties for marketing, product demand, competition, substantial dependence on one product and other risks identified in the Company's Annual Report on Form 10-K for the year ended December 31, 1996, as filed with the Securities and Exchange Commission. |
