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, announced
that the United States Food and Drug Administration has granted the
company orphan-drug designation for resveratrol in the treatment of
MELAS syndrome (Mitochondrial myopathy, encephalopathy, lactic acidosis,
and stroke-like episodes). Orphan-drug designation for resveratrol in
MELAS syndrome provides Sirtris with seven years of marketing
exclusivity upon receipt of FDA approval.
“MELAS can have a devastating effect on the
quality of life of patients and their families,”
says Professor Patrick Chinnery of Newcastle University, who is leading
a MELAS Phase 1b clinical trial in the United Kingdom with SRT501,
Sirtris’ proprietary formulation of
resveratrol. “Finding treatments for MELAS and
the many other mitochondrial-related illnesses is essential,”
says Chinnery, whose focus is the treatment and research of
mitochondrial disorders.
“Many diseases of aging, such as Type 2
Diabetes, exhibit impaired mitochondrial function,”
says Peter Elliott, PhD, Sirtris Senior Vice President of Development. “As
we target SIRT1, a gene tied to the aging process and improved
mitochondrial function, we hope to develop new therapies for diseases
like MELAS and Type 2 Diabetes.”
"We are extremely pleased to have received orphan-drug designation in
MELAS," says Christoph Westphal, MD, PhD, CEO and Vice Chair, Sirtris
Pharmaceuticals, Inc. “Clinical testing with
SRT501 in this mitochondrial disorder offers the potential to provide an
exciting, novel treatment option for the future.”
MELAS is a progressive and fatal disorder with no known treatments. The
earliest symptoms include muscle weakness, fatigue, recurrent headaches
and seizures. The reported age of onset varies between 3 and 40 years,
with most patients presenting between the ages of 5 to 15 years. The
syndrome can manifest as stroke-like episodes in patients under 20 years
of age. Seizures, dementia, impaired muscular function and
neurodegeneration can be observed as the disease progresses. MELAS
patients also have high glucose levels and approximately 30 percent have
Type 2 Diabetes.
MELAS is caused by a point mutation in mitochondrial DNA, leading to the
development of poorly functioning mitochondria, which supply cellular
energy. The diagnosis can be confirmed through genetic testing.
In preclinical testing, activation of the SIRT1 enzyme with SRT501 has
been shown to increase the number and function of mitochondria. SRT501
has also been shown to be safe and well-tolerated in two earlier human
Phase 1a clinical trials. In a Phase 1b clinical trial with Type 2
Diabetes patients naïve to treatment, SRT501
was shown to be safe and to significantly lower glucose at the two-hour
time point in an oral glucose tolerance test conducted as part of the 28
day trial.
The Phase 1b trial for MELAS conducted at Newcastle University is
designed to test the primary endpoints of safety and pharmacokinetics of
SRT501 in patients with MELAS. SRT501 is being administered to a group
of 15 patients once daily for three months and an additional group of
five patients will receive a placebo. Secondary endpoints include
exercise tolerance, and fasting blood glucose and insulin levels.
Sirtris expects data from this trial in the first half of 2009.
The United States Orphan Drug Act of 1983 was created to provide
incentives for companies to develop and market treatments for diseases
affecting fewer than 200,000 people in the United States. Under the
Orphan Drug Act, more than 300 new drugs have been developed and
approved.
Sirtris plans to seek orphan drug status for SRT501 in Europe.
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 the
Company believes control the aging process. Sirtris Pharmaceuticals is
engaged in human clinical trials for Type 2 Diabetes, and is planning
similar trials in cancer, another age-related disease. Sirtris is also
engaged in a human clinical trial for MELAS, a mitochondrial disorder.
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 expression and activation for diseases of aging, such
as Type 2 Diabetes and MELAS; the progress, timing and results of
preclinical and clinical studies of SIRT1 activators; the success of new
therapies for Type 2 Diabetes and MELAS; and the potential of sirtuin
modulators 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.