TPTX » Topics » Posiphen for Alzheimers Disease

This excerpt taken from the TPTX 10-K filed Mar 29, 2007.

Posiphen™ for Alzheimer’s Disease

Posiphen, the positive isomer of phenserine, has potential application as a disease modifying agent to slow or delay the progression of Alzheimer’s disease. Posiphen has been shown to lower beta-amyloid precursor protein and beta-amyloid levels in preclinical studies. Two Phase I clinical trials have been completed for Posiphen. The first Phase I single ascending dose clinical trial was completed in January 2006. The data from this double-blind, placebo controlled clinical trial in healthy men and women demonstrated that Posiphen appears to be well tolerated at single doses up to and including 80mg with no serious adverse events being reported.

In May 2006, we announced the completion of a multiple dose Phase I clinical trial with Posiphen in healthy volunteers. This multiple ascending-dose clinical trial examined the effects of 20, 40 and 60 mg doses of Posiphen given four times daily, for a period of 7, 7 and 10 days, respectively. Participants were enrolled in groups of 16, with 12 subjects receiving Posiphen and 4 subjects receiving placebo. The clinical adverse event data from this clinical trial appears to be generally consistent with the results of the earlier single ascending dose Phase I clinical trial that suggested that Posiphen was well tolerated with no serious adverse events reported. There are currently no plans to conduct additional clinical trials with Posiphen in patients with Alzheimer’s disease in 2007.

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