Phytopharm Alzheimer’s study clears safety review

The phase II proof of principle study is to evaluate Phytompharm’s PYM50028 (Cogane), an orally active, synthetic, neuroprotective and neuroregenerative product under development as a treatment for Alzheimer’s disease.

The study is being conducted in the UK under the terms of a clinical trial authorization (CTA), which has been granted by the Medicines and Healthcare products Regulatory Agency (MHRA).

The placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetic profile of PYM50028 after once daily oral administration for 12 weeks to patients with Alzheimer’s disease.

In accordance with the protocol, an interim review was conducted after the first 60 subjects completed the study. The objectives of this review were to evaluate the emergent safety profile of the study and to re-estimate the total number of subjects required to measure the efficacy of PYM50028 on cognitive performance.

The safety review was conducted by an independent consultant physician, who was provided with blinded data for each of the two treatment groups. He concluded that “the data obtained to date indicate that the study medication is not associated with any safety concerns.” Therefore, the study will continue with no changes to the safety monitoring.

A sample size re-assessment was also conducted by an independent statistician, who reported that the sample size for the study should be increased from 200 to 238 subjects. Phytopharm is seeking regulatory and ethics approval for this amendment.

“We are encouraged by the emerging safety profile of Cogane and look forward to completing the study by the end of the year,” said Dr Richard Dixey, chief executive of Phytopharm.

In May 2003, Phytopharm entered a licensing agreement with Yamanouchi Pharmaceutical Co for the development and commercialization of PYM50028 in Japan and other Asian territories.