Safety concerns force Glaxo to suspend enrollment in SRT501 trial

GlaxoSmithKline opted to suspend enrollment in a study of SRT501--the jewel in the crown of Sirtris Pharmaceuticals when it was acquired two years ago for $720 million--after five of the 24 subjects in a safety study developed kidney damage.

SRT501 is a special formulation of resveratrol, an ingredient in grapes that has been linked to a wide array of health benefits. Researchers were evaluating the safety of the drug alone and in combination with Velcade when they spotted the cast nephropathy that has developed in several patients with multiple myeloma. According to a report in Bloomberg, that kind of kidney damage can develop in patients with multiple myeloma.

A spokesperson for Glaxo told Bloomberg that the study could resume at a later point and that several of the patients in the trial had opted to continue treatment. SRT501 has been the subject of intense interest and is being studied for a range of conditions that include Alzheimer's, obesity, diabetes and cancer. Three trials for Type 2 diabetes have been completed.

The trial was actually suspended on April 22, according to a listing at clinicaltrials.gov, which cited "unexpected safety reasons." Derek Lowe, a well known biotech blogger who writes In The Pipeline, first noted the suspension on Monday.

- here's the Reuters story
- here's the Bloomberg piece
- here's the item from Derek Lowe

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