London-based GlaxoSmithKline has terminated a mid-stage clinical trial of SRT501 in patients with advanced multiple myeloma, the company said in a statement e-mailed to Xconomy today. The firm acquired the drug, a formulation of resveratrol, in its $720 million buyout of Cambridge, MA-based Sirtris Pharmaceuticals in 2008.
Sirtris has captured wide media attention because of the potential anti-aging benefits of the naturally occurring chemical resveratrol, which can be found in the skin of red grapes and in red wine.
Glaxo decided to end the trial after a review of data from the study found that the formulation of resveratrol “may only offer minimal efficacy while having a potential to indirectly” cause kidney complications that often occur in myeloma patients, according to the company’s statement. The Myeloma Beacon first reported the news about the recent decision to terminate the trial yesterday. Multiple myeloma is a type of cancer found in plasma cells.
The Phase IIa clinical trial tested the use of SRT501 with and without the approved cancer treatment bortezomib (Velcade), according to the government’s clinical trials website.
Glaxo had suspended enrollment of the study in April of this year after cases of acute kidney failure were found in five study patients, according to the company. In the company’s analysis of these cases, it “concluded that these renal failure cases were most likely due to the underlying disease, as kidney complications related to myeloma occur in up to 50 [percent] of cases. However, the formulation of SRT501 was not well tolerated, and side effects of nausea/vomiting/diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute renal failure,” the company said.
Glaxo, which continues to operate Sirtris as its subsidiary in Cambridge, said that it is now focusing on “selective SIRT1 activator compounds that have no chemical relationship to SRT501 and more favorable drug-like properties.” Those selective activators include compounds known as SRT2104 and SRT2379.
