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Sirtris press release
Started by
sUper GeNius
, Jul 17 2007 07:24 PM
7 replies to this topic
#2
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Posted 09 August 2007 - 03:09 PM
Here's the latest Sirtris Release:
Sirtris Pharmaceuticals, Inc. Announces Initiation of Phase 1b Clinical Trial of SRT501 in MELAS
Rare, Progressive Disorder Caused by Mutation in DNA of Mitochondria Has No Known Treatments
Last Update: 8:00 AM ET Aug 9, 2007
CAMBRIDGE, Mass., Aug 09, 2007 (BUSINESS WIRE) -- Sirtris Pharmaceuticals, Inc.
SIRT12.44, +0.32, +2.6% ) , 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.
Sirtris Pharmaceuticals, Inc. Announces Initiation of Phase 1b Clinical Trial of SRT501 in MELAS
Rare, Progressive Disorder Caused by Mutation in DNA of Mitochondria Has No Known Treatments
Last Update: 8:00 AM ET Aug 9, 2007
CAMBRIDGE, Mass., Aug 09, 2007 (BUSINESS WIRE) -- Sirtris Pharmaceuticals, Inc.
SIRT12.44, +0.32, +2.6% ) , 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.
#3
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Posted 09 August 2007 - 03:15 PM
I checked the little slide show screen shots here:
http://www.revgenetics.com/sirtris.htm
because I thought it was already in progress, but slide 21 shows it was not in progress at that time before the IPO.
So this news appears to be new.
A
http://www.revgenetics.com/sirtris.htm
because I thought it was already in progress, but slide 21 shows it was not in progress at that time before the IPO.
So this news appears to be new.
A
#8
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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
-----------------------------------
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.
I found the following yesterday on the SIRTRIS website:
BTW. Their stocks are doing good in the recent bearish market..hm,
MM
-----------------------------------
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.
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