Glaxo's 'Red Wine' Drug Trial Halted Over Safety Concerns
By PETER LOFTUS
A clinical trial of an experimental GlaxoSmithKline PLC drug designed to harness the potential anti-aging effects of red wine has been halted for "unexpected safety events," according to an online database.
The mid-stage trial was testing the safety and tolerability of adding the experimental drug, SRT501, to the cancer drug Velcade in people with multiple myeloma in the U.K. and Denmark, according to a summary on clinicaltrials.gov, a service of the National Institutes of Health. Velcade is co-marketed by Takeda Pharmaceutical Co. and Johnson & Johnson.[I wonder why this particular combination of drugs was in clinicals. Comments?]
The study began in March 2009 and was intended to run through December 2010, according to clinicaltrials.gov. The estimated enrollment was 61 patients. The trial listing was updated April 22 to say it was suspended.
GlaxoSmithKline spokeswoman Sarah Alspach said Tuesday that a number of trial participants developed a complication generally associated with myeloma. New-patient enrollment has been put on hold while the company analyzes the data and determines its next steps. GlaxoSmithKline has notified trial investigators and regulators in the U.K. and Denmark about the trial suspension.
The blog In the Pipeline reported the trial's suspension Monday, citing the clinicaltrials.gov update.
SRT501 is a proprietary formulation of resveratrol, a substance found in red wine that is believed to have health effects.
GlaxoSmithKline obtained the compound with its $720 million purchase of Sirtris Pharmaceuticals in 2008. The drug also has been tested in other diseases, including diabetes.
Write to Peter Loftus at peter.loftus@dowjones.com
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