While scores of studies over the last decade have suggested the benefits of the compound Resvatrol, a recent clinical trial of a proprietary form of resveratrol has been suspended due to safety concerns.  The resveratrol-based drug, SRT501, was being studied in a Phase 2 trial with multiple myeloma patients.  Phase 2 trials usually are the first clinical trials that look in detail at a drug’s potential effectiveness.

SRT501, which is not yet approved by the Food & Drug Administration, is being developed by Sirtris Pharmaceuticals, a Cambridge, Massachusetts, biotech company.  Sirtris was founded in 2004 and acquired in 2008 by the British pharmaceutical company GlaxoSmithKline.
Sirtris describes SRT501 as a “proprietary formulation of resveratrol” with an improved ability to deliver the drug where it is needed in a patient’s body.  In the halted clinical trial, SRT501 was to be administered orally once daily.  Some of the multiple myeloma patients in the trial were to take SRT501 while also receiving treatment with Velcade (bortezomib).  Others were to take only SRT501.

The information about the trial is viewable at the ClinicalTrials.Gov website, which is maintained by the United States National Institutes of Health. The suspended trial appears to be the first SRT501 trial carried out with multiple myeloma patients.  Earlier trials, which were completed without any reports of safety issues, involved either healthy participants, patients suffering from diabetes, or patients with colorectal cancer.

Reports indicate that the SRT501 trial was halted after 24 patients had enrolled in the trial. Of the 24 patients, five developed a kidney condition called cast nephropathy. Cast nephropathy is so commonly associated with multiple myeloma that it is often called “myeloma kidney.” It also is one of the main contributors to kidney failure in myeloma patients.

Tags: Resveratrol