Posted 22 August 2007 - 06:15 AM
Hiya,
I found the following yesterday on the SIRTRIS website:
BTW. Their stocks are doing good in the recent bearish market..hm,
MM
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Sirtris Pharmaceuticals Initiates Phase 2a Clinical Trial in Patients with Type 2 Diabetes
Combination of SIRT1 activator with metformin to be evaluated
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 21, 2007--Sirtris Pharmaceuticals (NASDAQ: SIRT), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat diseases of aging, announced today the initiation of a Phase 2a clinical trial in India to evaluate its SRT501 product candidate in patients with Type 2 Diabetes whose glucose levels are not adequately controlled by their metformin treatment, a current first-line therapy for such patients.
Patients on metformin alone that have an HbA1c level greater than 7.5 percent, which suggests that their glucose levels are not adequately controlled by current treatment, will be allowed to enter this randomized, double-blind, placebo-controlled Phase 2a trial. Such patients will continue on their current metformin therapy together with either SRT501 or placebo, which will be administered once daily for three months. The trial endpoints will focus on measurements of diabetic status including fed and fasting glucose, insulin, and HbA1c levels. The trial is expected to enroll 130 patients; 65 patients in each of the SRT501 and placebo cohorts. This trial will also further assess the safety and pharmacokinetics of SRT501 in the diabetic population. Results from this trial are expected at the end of 2008.
Peter Elliott, Ph.D., Senior Vice President of Development said, "Metformin is a first-line therapy for Type 2 Diabetes in the United States, and this trial will provide us with insights into the safety and activity of SRT501 as well as the potential for synergy of SIRT1 activators with metformin."
"We are pleased to continue to advance the clinical development of SRT501 to treat diseases of aging such as Type 2 Diabetes. We also have a pipeline of SIRT1 activators, which are chemically distinct from and one thousand times more potent than SRT501," said Christoph Westphal, M.D., Ph.D., Chief Executive Officer of Sirtris.
The Company also has two additional trials of SRT501 in progress in patients with Type 2 Diabetes. These trials are evaluating SRT501, administered at 2 different doses, for 28 days in patients naive to other diabetes drug treatment. SRT501 is also being evaluated in patients with MELAS Syndrome (Mitochondrial Encephalopathy Lactic Acidosis and Stroke-like episodes), a rare mitochondrial disorder. SRT501 represents the first clinical-stage drug candidate in a portfolio of proprietary compounds based on Sirtris' sirtuin drug discovery platform.
About SRT501
SRT501, Sirtris' proprietary version of resveratrol and initial clinical candidate, activates the sirtuin, SIRT1. SIRT1 is a member of the human sirtuin family of enzymes. Specifically, SRT501 acts by increasing mitochondrial activity in pre-clinical models of disease, and we believe it may be therapeutic for metabolic diseases like Type 2 Diabetes as well as mitochondrial disorders such as MELAS Syndrome. Novel chemical entities, SIRT1 activators which are structurally unrelated to and one thousand times more potent than SRT501, expand the pipeline of drug candidates for Sirtris.
Sirtuins are a recently-discovered family of enzymes that appear to regulate certain beneficial effects of calorie restriction. There are seven human sirtuins (SIRT1-7), each having a different sub-cellular localization. Sirtris believes that sirtuins are attractive drug targets since some have a specialized function in mitochondrial activity which may be therapeutically beneficial for metabolic and other diseases. By harnessing a natural process, Sirtris believes sirtuin therapeutics offer the potential for a novel class of drugs that can treat significant diseases of aging in a new way.