Sirtris Pharmaceuticals, Inc. Announces Initiation of Phase 1b Clinical Trial of SRT501 in MELAS
09 August 2007 - 10:00PM
Business Wire
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, today announced
the initiation of a Phase 1b clinical trial of SRT501 in patients
in Europe with MELAS Syndrome (Mitochondrial Encephalopathy Lactic
Acidosis and Stroke-like episodes). MELAS is a progressive and
fatal disorder caused by a mutation in the DNA of the mitochondria
that mainly affects muscles and nerves leading to reduced exercise
capacity and eventually muscle failure. There are currently no
known treatments for patients with MELAS Syndrome. �We are pleased
to continue to advance the clinical development of SRT501 into this
area of significant unmet medical need. We believe MELAS represents
an orphan drug opportunity,� said Peter Elliott, Ph.D. Senior Vice
President of Development at Sirtris. This Phase 1b trial is
designed to test the primary endpoints of safety and
pharmacokinetics of SRT501 in patients with MELAS. SRT501 will be
administered to a group of 15 patients once daily for three months
and an additional group of 15 patients will receive placebo.
Secondary endpoints include exercise tolerance, and fasting blood
glucose and insulin levels. Sirtris expects data from this trial by
the end of 2008. �In addition to MELAS, SRT501 is also being
evaluated in two Phase 1b clinical trials in patients with Type 2
Diabetes with results expected in the first of these trials later
this year. SRT501 represents the first in a portfolio of sirtuin
activators, including novel chemical entities which are even more
potent than SRT501, intended to treat a range of diseases of
aging,� said Christoph Westphal, M.D., Ph.D., Chief Executive
Officer of Sirtris. 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 and may target metabolic diseases like Type 2 Diabetes as
well as mitochondrial disorders such as MELAS. 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
neurological 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.
About MELAS Syndrome Based on market research, Sirtris estimates
that there are between 5,000 � 10,000 patients with MELAS both in
the United States and Europe, although the true rate of incidence
is unknown. MELAS is a rare mitochondrial disorder caused by a
mutation in the genetic material of an intracellular structure that
releases energy (mitochondria). The most characteristic symptom of
MELAS is exercise intolerance and recurring, stroke-like episodes
in which sudden headaches are followed by vomiting and seizures.
Short stature, an accumulation of lactic acid in the blood (lactic
acidosis), and muscular weakness on one side of the body are often
also associated with MELAS. 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 for multiple neurodegenerative diseases and
other types of disorders, the progress and results of pre-clinical
studies of SIRT1 activators, 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.
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