There’s bad news this week about one of the much-hyped drug candidates based on the red wine chemical called resveratrol. Several news outlets are reporting that safety concerns have prompted GlaxoSmithKline to halt a mid-stage clinical trial of the drug, called SRT501, which the London-based drug giant gained in its $720 million buyout of Sirtris Pharmaceuticals in 2008.
Glaxo put a stop to a Phase II trial of the drug in patients with multiple myeloma, a cancer of the bone marrow and plasma, after some patients in the study developed a condition that can lead to kidney failure, according to the Wall Street Journal. Some of the patients in the trial were also taking bortezomib, an approved cancer drug marked as Velcade. The chemist Derek Lowe broke this news on his blog, “In the Pipeline,” on Monday based on an April 22 update on the trial posted on ClinicalTrials.gov, a U.S.-government-run registry of clinical trials.
Normally, the failure of a mid-stage trial at a big pharmaceutical company wouldn’t generate tons of press coverage, but this study is different—perhaps because we reporters have heaped so much coverage on Sirtris, resveratrol, and related “anti-aging” drugs in the first place. (Resveratrol and drugs candidates like SRT501 that are based on it are believed to activate anti-aging enzymes called sirtuins.)
Despite the concerns in Glaxo’s multiple myeloma trial, Sirtris’s formulation of resveratrol had previously been studied in patients with diabetes and other cancers without the same safety problems. Also, Sirtris, which now operates as a subsidiary of Glaxo, says that it has discovered new compounds that are vastly more potent than resveratrol and SRT501, and one such new compound has become the focus of its efforts to find new ways to treat diabetes. Still, the ill-fated study of SRT501 in multiple myeloma is one reason to remain skeptical of the health benefits of resveratrol until they can be proven in further human studies.
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