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Small study of “red wine” drug suspended
May 06, 10 Clinical UpdatesA clinical trial testing an experimental GlaxoSmithKline drug that mimics a health-boosting compound found in red wine has been suspended due to safety issues.
A company spokeswoman said on Tuesday that the trial of SRT501 in patients with multiple myeloma had been suspended after a number of them developed a complication generally associated with the disease, which is a type of blood cancer.
The mid-stage Phase II study, conducted in Britain and Denmark, was assessing the safety and tolerability of SRT501 with or without the established cancer drug Velcade from Takeda Pharmaceutical.
SRT501 is a proprietary formulation of resveratrol, a substance found in grapes and in red wine.
The clinical trial was started in March 2009 and was due to run until December 2010. It was suspended prematurely following “unexpected safety events,” according to an update to the clinicaltrials.gov database on April 22.
The suspension came after the enrollment of 24 patients out of a target of 61.
Resveratrol is believed to provide a number of health benefits, including preventing heart disease and potentially slowing the aging processes, making it an attractive target for drug developers.
Glaxo acquired SRT501 when it bought biotech company Sirtris Pharmaceuticals for $720 million in 2008.
Company spokeswoman Sarah Alspach said new patient enrollment into the study had been put on hold while experts analyzed data collected to date.
“Patients who were on the study were informed of the development and were asked to re-consent if they wished to continue on the trial. She said some patients had continued on the study.
The same drug has been tested in three other clinical trials for type 2 diabetes, all of which have been completed.
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