Theratechnologies’ Tesamorelin

[cvictorg]

Theratechnologies’ Tesamorelin HIV Drug On the Road to FDA Approval ? Tech Jackal

The FDA advisory panel has unanimously agreed that a drug designed to reduce belly fat in HIV patients is safe to distribute. The FDA will still have the final decision, but typically, they follow the panel’s recommendations. The decision is due by July 27th. The approval recommendation has been based on drug trials that produced favorable results.


NEJM -- Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV

Metabolic Effects of a Growth Hormone–Releasing Factor in Patients with HIV

Background Visceral adipose tissue accumulates during antiretroviral therapy in many patients who are infected with the human immunodeficiency virus (HIV); this process is associated with an increased cardiovascular risk. We assessed the use of a growth hormone–releasing factor analogue, tesamorelin, to decrease visceral adiposity.

Methods We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks. The primary end point was the percent change from baseline in visceral adipose tissue as shown on computed tomography. Secondary end points included triglyceride levels, the ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol, the level of insulin-like growth factor I (IGF-I), and self-assessed body image. Glycemic measures included glucose and insulin levels.

Results The measure of visceral adipose tissue decreased by 15.2% in the tesamorelin group and increased by 5.0% in the placebo group; the levels of triglycerides decreased by 50 mg per deciliter and increased by 9 mg per deciliter, respectively, and the ratio of total cholesterol to HDL cholesterol decreased by 0.31 and increased by 0.21, respectively (P<0.001 for all comparisons). Levels of total cholesterol and HDL cholesterol also improved significantly in the tesamorelin group. Levels of IGF-I increased by 81.0% in the tesamorelin group and decreased by 5.0% in the placebo group (P<0.001). Adverse events did not differ significantly between the two study groups, but more patients in the tesamorelin group withdrew from the study because of an adverse event. No significant differences were observed in glycemic measures.

Conclusions Daily tesamorelin for 26 weeks decreased visceral fat and improved lipid profiles, effects that might be useful in HIV-infected patients who have treatment-associated central fat accumulation. (ClinicalTrials.gov number, NCT00123253

 

[Michael Scally MD]

Re: Theratechnologies’ Tesamorelin HIV Drug On the Road to FDA Approval

FDA Panel Gives Thumbs Up for Egrifta (Lipodystrophy): https://thinksteroids.com/community/threads/134291612

 

[cvictorg]

Re: Theratechnologies’ Tesamorelin HIV Drug On the Road to FDA Approval

FDA Panel Gives Thumbs Up for Egrifta (Lipodystrophy): https://thinksteroids.com/community/threads/134291612

Interesting - I post a link to a study - you then post a link to the SAME study - why is that??

 

[Michael Scally MD]

Re: Theratechnologies’ Tesamorelin HIV Drug On the Road to FDA Approval

Interesting - I post a link to a study - you then post a link to the SAME study - why is that??

I try to provide the pdf for easy download and availability! Personally, I wish more posters would take the time to provide the download. The link in the post was to an earlier post on the same subject.

 

[Michael Scally MD]

Re: Theratechnologies’ Tesamorelin HIV Drug On the Road to FDA Approval

FDA NEWS RELEASE

For Immediate Release: Nov. 10, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Egrifta to treat Lipodystrophy in HIV patients
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm233516.htm

The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.

Egrifta, the first FDA-approved treatment for lipodystrophy, is a growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.

"The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”

Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied.

Egrifta was evaluated in two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat. Of these, 543 patients received Egrifta during a 26-week, placebo-controlled period. In both studies, patients treated with Egrifta experienced greater reductions in abdominal fat as measured by CT scan, compared with patients receiving another injectable solution (placebo). Some patients reported improvements in their self image.

The most commonly reported side effects in the studies included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.

Egrifta was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Mass.-based EMD Serono.

 

[Michael Scally MD]

THERATECHNOLOGIES ANNOUNCES NEW CLINICAL PROGRAM IN MUSCLE WASTING IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Theratechnologies announces new clinical program in muscle wasting in Chronic Obstructive Pulmonary Disease (COPD) - News - Theratechnologies, TSX TH, Tesamorelin, Lipohypertrophy, Lipodystrophy therapy

Montréal, Canada - February 22, 2011 - Theratechnologies (TSX: TH) today announced a new clinical program for muscle wasting in Chronic Obstructive Pulmonary Disease (COPD) using the Company's lead compound, tesamorelin, a human growth hormone releasing factor ("GRF") analogue.

Based on tesamorelin's anabolic properties, the Company has chosen to pursue the development of its lead compound in muscle wasting in patients with COPD as its second indication. COPD is characterized by progressive airflow obstruction due to chronic bronchitis or emphysema leading in certain cases to muscle wasting, a decrease of muscle mass and deterioration in functionality. Previously, Theratechnologies completed a Phase 2 trial in stable ambulatory COPD patients which demonstrated a statistically significant increase in lean body mass. The Company intends to commence a second Phase 2 clinical study in the second half of 2011 to test different dosages of tesamorelin with a new formulation.

Based on available market and industry data, the Company estimates that in 2009, the number of diagnosed COPD patients in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage II or III suffering from a muscle wasting condition, with a body mass index under 25, was approximately 3.1 million in the United States, France, Germany, Italy, United Kingdom, Spain and Japan.

"There are a large number of patients who suffer from muscle wasting in COPD and it is our hope that we can eventually improve the condition of those patients in need," stated Mr. John-Michel T. Huss, President and CEO of Theratechnologies. "Expanding into this new disease area will allow us to maximize the global commercial potential of tesamorelin," he commented. "This is further evidence regarding our ability to deliver on our promise, as a management team, and a demonstration of our commitment to grow our company as well as solidify the future of Theratechnologies," Mr. Huss concluded.

The Phase 2 clinical study will evaluate the use of tesamorelin in a randomized, placebo controlled study with approximately 200 COPD patients, in GOLD stage II and III, with muscle wasting. Patients will be randomized to receive either one of two different dosages of tesamorelin or placebo each day for six months. Theratechnologies intends to randomize its first patient in the second half of 2011. The primary endpoint will be an increase in lean body mass. Other efficacy endpoints will be measured, such as a six-minute walking distance test, exercise endurance time, and quality of life (daily activities). Safety assessments will include monitoring of adverse events and laboratory evaluations. If the Phase 2 study is successful, two Phase 3 studies (one pivotal and one confirmatory) are to be conducted in parallel. This clinical trial program is estimated to take approximately four years and will use a new and more concentrated formulation of tesamorelin. The new formulation will require a smaller volume of injection and is expected to be stable at room temperature.

"We have already led a successful clinical program based on the lipolytic properties of tesamorelin and are now expanding into muscle wasting in COPD based on the anabolic properties of tesamorelin," commented Dr. Christian Marsolais, Vice-President, Clinical Research and Medical Affairs. "We are hoping to demonstrate that the increase of muscle mass by tesamorelin will have a positive impact on the functionality of the COPD patients with muscle wasting," he concluded.