Theratechnologies, a Canada-based developer of therapeutic peptide products, has started screening of patients in a Phase 2 trial to assess tesamorelin as a treatment for muscle wasting in patients with chronic obstructive pulmonary disease (COPD).
Tesamorelin is a growth hormone-releasing factor (GRF) analogue that induces growth hormone production and its anabolic properties have led Theratechnologies to pursue its development in muscle wasting in patients with COPD as a second indication for the compound.
A previously concluded phase 2 trial in stable ambulatory COPD patients has demonstrated a statistically significant increase in lean body mass (LBM).
The study will evaluate the efficacy and safety of a daily administration of either a 2mg or 3mg dose of a new formulation of tesamorelin for a period of 26 weeks.
The double-blind, multi-center, placebo-controlled, randomized trial is expected to be conducted in 25 centers across US and Canada.
The company expects to enroll about 200 patients and the trial results are expected before the end of 2012.
Showing posts with label Tesamorelin. Show all posts
Showing posts with label Tesamorelin. Show all posts
New study on Egrifta ( tesamorelin ) compared to Serostim (HGH) in HIV + men.
Appleby discussed the differences between EGRIFTA and Serostim, a synthetic version of Human Growth Hormone that is FDA approved for the treatment of HIV-related wasting and weight loss. In its trials, Serostim also reversed the effects of lipodystrophy, but the FDA was not convinced that the risks associated with Serastim outweighed its benefits with lipodystrophy, and did not approve it for that purpose.
The differences between Serostim and EGRIFTA are significant. Serostim (generic name: somatropin) is a daily injection of a synthetic hormone that often comes with severe side effects including joint and muscle pain, swelling, and an increase in glucose levels in the bloodstream that can increase the risk of diabetes. The desired effects of Serostim begin to be visible after a few weeks on the drug, and the monthly cost is a staggering $10,000. EGRIFTA (generic name: tesamorelin) is a daily injection of a drug that causes the body to produce its own growth hormone. The possible side effects, including fluid retention, pain, rash and glucose intolerance, are mild in comparison to Serostim. The good results begin to be visible in three months, and the monthly cost of treatment is a less staggering $2,900.
EGRIFTA will not reverse facial wasting and will not increase arm or leg width. It does not address the kind of fat that is acquired through overeating and not exercising. It specifically targets fat surrounding the internal organs in the abdomen.
Appleby described the trials that led to the FDA approval of EGRIFTA. No one with an active malignancy was allowed to participate, and all participants had to be off Serostim for at least 6 months. Those in the study were also asked to follow a healthy diet and exercise routine. The critical results were calculated not in weight but in fat distribution measurements. Steve was one of the participants in those trials who experienced a satisfying reduction of his lipohypertrophy, and then its unfortunate return after the treatments ended.
Despite the fact that the FDA has approved EGRIFTA as a treatment for a syndrome that can be damaging to the cardio-vascular system, the biggest marketing hurdle is the refusal of many insurance companies to consider it anything more than a cosmetic treatment. Those insurers are also shortsighted in their refusal to see that erasing the scarlet letter of HIV infection will have a restorative impact on the daily lives of HIV-positive men, with an overall betterment of their health and a consequential lowering of other costly HIV-related treatments and medications covered by most health insurance providers. During the question and answer portion of the EGRIFTA seminar, some spoke about the unclear possibility of a patient assistance program and about current monthly co-pays that vary drastically from a few dollars to a reported high of $600. In the USA, EGRIFTA is distributed by Serono Laboratories and is not currently available at some of the national drug store chains. Many HIV doctors are still unfamiliar with EGRIFTA, and their patients are driving their continued education with requests for the treatment.
After the seminar, Steve reported that the attendees were satisfied that EGRIFTA’s benefits are clear, as was the fact that there is little that can be done but wait for the drug’s developer and marketer to battle successfully with health insurance companies that consider it an unnecessary cosmetic intervention, similar to liposuction.
At the POZitive Attitudes meeting, Appleby was preaching to the choir when he concluded his seminar by saying “The bottom line is that EGRIFTA is a good drug with few side effects.”
The differences between Serostim and EGRIFTA are significant. Serostim (generic name: somatropin) is a daily injection of a synthetic hormone that often comes with severe side effects including joint and muscle pain, swelling, and an increase in glucose levels in the bloodstream that can increase the risk of diabetes. The desired effects of Serostim begin to be visible after a few weeks on the drug, and the monthly cost is a staggering $10,000. EGRIFTA (generic name: tesamorelin) is a daily injection of a drug that causes the body to produce its own growth hormone. The possible side effects, including fluid retention, pain, rash and glucose intolerance, are mild in comparison to Serostim. The good results begin to be visible in three months, and the monthly cost of treatment is a less staggering $2,900.
EGRIFTA will not reverse facial wasting and will not increase arm or leg width. It does not address the kind of fat that is acquired through overeating and not exercising. It specifically targets fat surrounding the internal organs in the abdomen.
Appleby described the trials that led to the FDA approval of EGRIFTA. No one with an active malignancy was allowed to participate, and all participants had to be off Serostim for at least 6 months. Those in the study were also asked to follow a healthy diet and exercise routine. The critical results were calculated not in weight but in fat distribution measurements. Steve was one of the participants in those trials who experienced a satisfying reduction of his lipohypertrophy, and then its unfortunate return after the treatments ended.
Despite the fact that the FDA has approved EGRIFTA as a treatment for a syndrome that can be damaging to the cardio-vascular system, the biggest marketing hurdle is the refusal of many insurance companies to consider it anything more than a cosmetic treatment. Those insurers are also shortsighted in their refusal to see that erasing the scarlet letter of HIV infection will have a restorative impact on the daily lives of HIV-positive men, with an overall betterment of their health and a consequential lowering of other costly HIV-related treatments and medications covered by most health insurance providers. During the question and answer portion of the EGRIFTA seminar, some spoke about the unclear possibility of a patient assistance program and about current monthly co-pays that vary drastically from a few dollars to a reported high of $600. In the USA, EGRIFTA is distributed by Serono Laboratories and is not currently available at some of the national drug store chains. Many HIV doctors are still unfamiliar with EGRIFTA, and their patients are driving their continued education with requests for the treatment.
After the seminar, Steve reported that the attendees were satisfied that EGRIFTA’s benefits are clear, as was the fact that there is little that can be done but wait for the drug’s developer and marketer to battle successfully with health insurance companies that consider it an unnecessary cosmetic intervention, similar to liposuction.
At the POZitive Attitudes meeting, Appleby was preaching to the choir when he concluded his seminar by saying “The bottom line is that EGRIFTA is a good drug with few side effects.”
Tesamorelin / Egrifta shows promise as an anabolic.
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.
Tesamorelin - the next trendy bodybuilding cutting drug ?
Tesamorelin is an effective medication for reducing treatment-related visceral adipose fat (VAT) in patients with HIV, a common problem with antiretroviral therapy. Substudies of 2 positive phase 3 trials of this drug were presented here at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
Both studies showed that tesamorelin was effective in reducing VAT across different subgroups of HIV-infected patients, and that reductions could be easily measured using waist circumference. Moreover, patients treated with this drug reported improvement in body image, researchers announced.
"A pooled analysis of 2 phase 3 clinical trials showed the efficacy of tesamorelin in reducing VAT, regardless of age, gender, race, hepatitis status, or antiretroviral regimen. Also, waist circumference measurements correlated with reductions in VAT seen on computed tomography [CT] scans," said Sophie Elise Michaud, PhD, an employee of Theratechnologies Inc. in Montreal, Quebec, who was coauthor of one of the studies.
Tesamorelin is an investigative analog of growth-hormone-releasing factor and growth-hormone-releasing hormone. The drug is pending approval by the US Food and Drug Administration (FDA), but some investigators are not enthusiastic about using it, except perhaps for specific indications.
Both substudies presented at ICAAC were based on pooled data from two 26-week studies that consisted of 816 HIV-positive patients randomized to tesamorelin or placebo. Mean age was 48 years, and about 85% were male. Mean body mass index at baseline was 29 kg/m2, mean waist circumference was 105 cm, and mean waist-to-hip ratio was 1.
At 26 weeks, tesamorelin significantly reduced VAT, compared with placebo, regardless of age (patients were divided into 2 groups — 47 years or younger and older than 47 years), sex, race (whites, blacks, or other races), hepatitis status, viral load (detectable or undetectable), or antiretroviral regimen (P < .01 for all analyses compared with placebo).
Long-term safety of tesamorelin was similar to that of the main study population in all subgroups. The lead author of this subgroup analysis was Julian Falutz, MD, from McGill University Health Centre in Montreal.
A second substudy of the same group of patients found that waist circumference was a useful and simple measurement to assess the magnitude of VAT reduction without having to resort to a CT scan, which was used in the original phase 3 studies. This analysis found that body image was improved and that this improvement correlated with reductions in VAT. Monica Zoltowska, PhD, an employee of Theratechnologies, was lead author of this substudy.
At week 26, waist circumference was reduced by 2.4 cm in patients treated with tesamorelin, compared with no reduction in the placebo group (P = .002). Belly appearance distress was also significantly improved from baseline in treated patients (P ≥ .15)
"Now we know that doctors can find out if the drug works by measuring waist circumference and asking patients about their level of body image distress," Dr. Michaud said.
In Dr. Lundgren's opinion, even if tesamorelin is approved, it will not be used that often. "As soon as the drug is stopped, the fat comes back, so treatment would have to be lifelong," he explained. Patients with VAT could try diet and exercise for their bellies, he added.
Both studies showed that tesamorelin was effective in reducing VAT across different subgroups of HIV-infected patients, and that reductions could be easily measured using waist circumference. Moreover, patients treated with this drug reported improvement in body image, researchers announced.
"A pooled analysis of 2 phase 3 clinical trials showed the efficacy of tesamorelin in reducing VAT, regardless of age, gender, race, hepatitis status, or antiretroviral regimen. Also, waist circumference measurements correlated with reductions in VAT seen on computed tomography [CT] scans," said Sophie Elise Michaud, PhD, an employee of Theratechnologies Inc. in Montreal, Quebec, who was coauthor of one of the studies.
Tesamorelin is an investigative analog of growth-hormone-releasing factor and growth-hormone-releasing hormone. The drug is pending approval by the US Food and Drug Administration (FDA), but some investigators are not enthusiastic about using it, except perhaps for specific indications.
Both substudies presented at ICAAC were based on pooled data from two 26-week studies that consisted of 816 HIV-positive patients randomized to tesamorelin or placebo. Mean age was 48 years, and about 85% were male. Mean body mass index at baseline was 29 kg/m2, mean waist circumference was 105 cm, and mean waist-to-hip ratio was 1.
At 26 weeks, tesamorelin significantly reduced VAT, compared with placebo, regardless of age (patients were divided into 2 groups — 47 years or younger and older than 47 years), sex, race (whites, blacks, or other races), hepatitis status, viral load (detectable or undetectable), or antiretroviral regimen (P < .01 for all analyses compared with placebo).
Long-term safety of tesamorelin was similar to that of the main study population in all subgroups. The lead author of this subgroup analysis was Julian Falutz, MD, from McGill University Health Centre in Montreal.
A second substudy of the same group of patients found that waist circumference was a useful and simple measurement to assess the magnitude of VAT reduction without having to resort to a CT scan, which was used in the original phase 3 studies. This analysis found that body image was improved and that this improvement correlated with reductions in VAT. Monica Zoltowska, PhD, an employee of Theratechnologies, was lead author of this substudy.
At week 26, waist circumference was reduced by 2.4 cm in patients treated with tesamorelin, compared with no reduction in the placebo group (P = .002). Belly appearance distress was also significantly improved from baseline in treated patients (P ≥ .15)
"Now we know that doctors can find out if the drug works by measuring waist circumference and asking patients about their level of body image distress," Dr. Michaud said.
In Dr. Lundgren's opinion, even if tesamorelin is approved, it will not be used that often. "As soon as the drug is stopped, the fat comes back, so treatment would have to be lifelong," he explained. Patients with VAT could try diet and exercise for their bellies, he added.
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