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Biotech / Medical : Procept (PRCT): 50% rise on high volume. Why? -- Ignore unavailable to you. Want to Upgrade?

To: Douglas who wrote (293)	11/14/1997 10:59:00 AM
From: Douglas	Respond to of 455

From the Autumn 1997 issue of MRC News "Chemical Condoms for Women" as written by Jonathan Weber and Valerie Kitchen (this is not the complete article, only some quotes). "With project grant support from the MRC, we set about identifying novel agents and designing phase I clinical trials which would allow us to determine rapidly the safety and acceptability of these new agents. First, we conducted a detailed study of N9 vaginal gel in 20 volunteers to determine its impact on the healthy vagina at a dose recommended for spermicidal use, 100 milligrams. We investigated the agent's effect on the epithelial cells lining the vagina, and on the normal microbial population of the vagina. We found that even a short course of N9 leads to inflammation in the vaginal epithelium in more than a third of the women, and to a temporary reduction in the beneficial lactobacilli bacteria. Next we looked at polymers, including dextrin sulphate (D2S), a sulphated sugar, and PRO2000, a sulphonic acid polymer. These compounds are made up of highly-charged molecules that inhibit the binding of HIV to the cell surface and so prevent infection. Both work well with little evidence of toxicity against normal cells in the test tube. A study of 36 women volunteers using D2S intravaginal gel has shown that this agent does not cause any inflammation and preserves normal vaginal bacteria. A similar study of PRO2000 is currently ongoing. We are now preparing a phase II comparative study to determine which agent or agents to take to phase III trials in the developing world. We expect to finish these phase II studies next year, with the aim of moving the most promising agent to phase III at the end of 1999. If all goes smoothly with the clinical trials, we could have a proven vaginal microbicide within five years."