Glaxo Stops Study of Sirtris “Red Wine” Drug in Cancer Patients

5/5/10

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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  • David Randolph

    Sirtris really messed this one up. This type of kidney dissease is KNOW AS “myeloma kidney” for pete’s sake. It is commonly found in myeloma. And further, they are giving the equivalent of 25 grams of resveratrol per day per patient. This whole thing is misleading.

  • Dr Shirley Kotter

    It is important to note that this is not resveratrol that Sirtris was using in the trial. It is a different molecule which they created and which Glaxo stated is 1,000 times as powerful as natural resveratrol. Transmax, the form of resveratrol used in human and in-vitro trials, has been found to be entirely safe even at very high doses. The Sirtris drug is an example of what often happens when a pharma takes a safe natural compound and modifies it or creates an synthetic analog in order to be able to patent and monopolize its sale.

  • Lyle

    Dr. Kotter is incorrect. SRT501 is not synthetic but a forumalation of resveratrol that is estimated to be 5 times as potent as only resveratrol. The 1000 times more potent synthetic drugs are not in cancer trials yet.

    I don’t think we know if 5g of SRT501 is really equivalent to 25g of resveratrol since it depends how the body absorbs it.

  • http://www.naturesoptimumhealthsolutons.com Terry L. Massey

    The real question from my standpoint is what percentage of myeloma patients experience kidney failure on their own. I am not a doctor but have been told by doctors that it is between 30 to 50%. If that is in fact true and the percentage occurrence in these subjects is less than this, one could draw the conclusion that resveratrol was working. I agree with David above. I believe this one is all about using FUD to scare Joe Consumer away from a very beneficial nutrient until big pharma can make it into a drug that they can charge big $ for. It is true that this is a fragile nutrient though and must be extracted in a way that does not allow it to come in contact with oxygen. Many supplement companies do not have this ability and may still list it as an ingredient on their labels. Another problem in our industry.

  • http://naturesoptimumhealthsolutions.com Terry L. Massey

    My name is correctly linked to my website in this post. I apologize for the improper link above.

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