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Biotech / Medical : Indications -- obesity/erectile dysfunction -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (347)	4/22/2014 3:40:39 PM
From: scaram(o)uche	Read Replies (3) \| Respond to of 435

>> Efficacy is not an issue. In phase III testing, toxicity will be a big one, imo. << In our dog studies we observed hypospermatogenesis, or low sperm counts, lowering of platelets, decreased white blood cell counts, gastrointestinal bleeding and seizures, all of which were reversible and occurred at doses and exposures above the human dose. The most sensitive changes were mild and reversible effects on spermatogenesis occurring at systemic drug exposures two-to-three fold above the human male exposure in the ZAF-201 trial. In our rat studies, we observed a sporadic, minimal and reversible reduction of sperm counts and cellular changes in the testes at exposure levels ten- to 15-fold above the male human exposure in the ZAF-201 trial. During these studies, the margins to the no adverse effect levels in females were 50- to 100-fold for rats and 40- to 60-fold for dogs. In addition, embryofetal studies have been conducted in rats that show a one- to two-fold exposure margins to female doses in the ZAF-201 trial. However, no safety margin in our rabbit studies were demonstrated due to minor and variant head and eye malformations. sec.gov