Sierra Natl BK Tehachapi Calif (MM) (NASDAQ:SIRT)
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Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical
company focused on discovering and developing small molecule drugs to
treat diseases of aging such as Type 2 Diabetes, announced today that
the Company’s first product to enter the
clinic, SRT501, was found to be safe and well-tolerated, and was found
to significantly lower glucose in an oral glucose tolerance test
conducted as part of a 28 day Phase 1b clinical study in patients with
Type 2 Diabetes. These data were presented at the 26th
Annual JPMorgan Healthcare Conference on Monday, January 7th
2008 at 1:30 pm PST in San Francisco.
This 28-day Phase 1b study was designed to assess the safety,
tolerability and pharmacokinetics of once-daily, orally administered
doses of either 2.5 g or 5 g of SRT501 in patients with Type 2 Diabetes
who were naïve to other diabetes drug
treatments. Both doses of SRT501 were found to be safe and
well-tolerated, and pharmacokinetics, a measure of drug levels in the
blood, were identical at days one and 28, suggesting no drug
accumulation. There were no serious adverse events and no dose-related
adverse events. Importantly, SRT501 showed a statistically significant
improvement in an oral glucose tolerance test on day 28 at two hours and
a trend towards lower fasting plasma glucose levels.
SRT501 is also being tested in patients with Type 2 Diabetes in a Phase
1b BID (twice daily administration) study and in a Phase 2a study in
combination with metformin, the current first-line therapy for Type 2
Diabetes. SIRT1 is the founding member of the human sirtuin family of
enzymes which control the aging process. Specifically, SRT501 acts by
increasing mitochondrial activity and therefore is targeted to address
metabolic diseases, such as Type 2 Diabetes.
"This is the first time that a small molecule targeting sirtuins, the
genes which control the aging process, has shown efficacy in a disease
of aging,” said Peter Elliott, Ph.D., Senior
Vice President of Development at Sirtris. “These
Phase 1b study results are an important step forward for Sirtris because
they represent significant progress in our clinical development of
sirtuin therapeutics. We are very pleased to see the safety profile
observed in preclinical studies translate into a well-tolerated drug
molecule in patients, and we are very encouraged by the glucose lowering
effects measured in the oral glucose test.”
Christoph Westphal, M.D., Ph.D., CEO and Vice Chair of Sirtris added,
"Effective treatment for Type 2 Diabetes, a disease of aging, is an
unmet medical need and sirtuin therapeutics may offer significant
potential. SRT501 may represent a promising treatment option for these
patients. We look forward to obtaining the results from our other Phase
1b clinical trial and the results from our Phase 2a clinical trial later
this year.”
About Sirtris Pharmaceuticals
Sirtris Pharmaceuticals is a biopharmaceutical company focused on
discovering and developing proprietary, orally available, small molecule
drugs with the potential to treat diseases associated with aging,
including metabolic diseases, such as Type 2 Diabetes. Our drug
candidates are designed to mimic certain beneficial health effects of
calorie restriction, without requiring a change in eating habits, by
activation of sirtuins, a recently discovered class of enzymes that
control the aging process. The company's headquarters are in Cambridge,
Massachusetts.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
statements include, but are not limited to, the potential therapeutic
effects of SIRT1 activators including SRT501 for diseases of aging, such
as Type 2 Diabetes, the progress and results of pre-clinical and
clinical studies of SIRT1 activators, the potential therapeutic effects
of SRT501 and other SIRT1 activators, and the potential of sirtuin
modulators and activators to receive regulatory approval. These
forward-looking statements about future expectations, plans and
prospects of Sirtris Pharmaceuticals involve significant risks,
uncertainties and assumptions, including risks related to the lack of
results that would provide a basis for predicting whether any of the
Company’s product candidates will be safe or
effective, or receive regulatory approval, the possibility that results
of pre-clinical studies are not necessarily predictive of clinical trial
results, the Company's potential inability to initiate and complete
pre-clinical studies and clinical trials for its product candidates, the
fact that none of the Company's product candidates has received
regulatory approvals, the potential inability of the Company to gain
market acceptance of the Company's product candidates, and those other
risks factors that can be found in the Company's filings with the
Securities and Exchange Commission. Actual results may differ materially
from those Sirtris Pharmaceuticals contemplated by these forward-looking
statements. Sirtris Pharmaceuticals does not undertake to update any of
these forward-looking statements to reflect a change in its views or
events or circumstances that occur after the date of this release.