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GTx also is developing ostarine, a first-in-class selective androgen receptor modulator, or SARM. GTx believes that ostarine has the potential to treat a variety of indications, including cancer cachexia, end stage renal disease muscle wasting, frailty and osteoporosis. GTx plans to initiate a Phase IIb ostarine clinical trial for cancer cachexia by the summer of 2007.
Data from the Phase II clinical trial of Ostarine are being highlighted at the GTx Analyst Day meeting being held today from 11 a.m. to 2 p.m. at the Loews Regency Hotel in New York City. During the meeting, GTx also will provide information about its clinical development plans and commercialization strategy for Ostarine, the company's first-in-class selective androgen receptor modulator (SARM).
In the three month Phase II clinical trial in which patients with diabetes or obesity (BMI greater than 30) were excluded, subjects treated with Ostarine 3 mg (n=23) had on average an 11% decline in fasting blood glucose (p less than 0.001), a 17.6% reduction in insulin levels (p=0.043), and a 26.8% reduction in insulin resistance (HOMA-IR) (p=0.037), when compared to their baseline measurements. Improvements in insulin resistance were more apparent among a small subset of prediabetic (fasting blood glucose of 100 - 125 mg/dL) patients (n=5) treated with Ostarine 3 mg in whom the mean fasting blood glucose declined by 17.4%, insulin levels reduced by 29.4%, and insulin resistance decreased by 41.3%.
Improvements in insulin resistance among subjects receiving the 3 mg dose provide additional supporting evidence of the anabolic activity of Ostarine. The resulting changes in body composition (increased muscle and decreased fat) with Ostarine treatment appear to have a beneficial impact on insulin resistance. These data compare favorably with results of clinical trials using FDA approved diabetic drugs in a prediabetic population. For example, in a one year study (the DREAM study), prediabetic patients taking rosiglitazone 8 mg evidenced a decline in fasting blood glucose of 9% from their baseline measurements (Lancet, 2006). Similarly, in prediabetic patients taking glipizide 2.5 mg for 6 months, the mean fasting blood glucose decreased by 4 percent, insulin declined by 17%, and insulin resistance reduced by 35% (Erikson JG et al, 2006). In prediabetic patients taking metformin 1.7 g for 16 weeks, fasting blood glucose declined by 6%, insulin decreased by 29%, and the calculated insulin resistance decreased by approximately 39% (Bulcao C et al, 2007).
"The data from our Phase II clinical trial provide more evidence that Ostarine is having the desired anabolic effect," said Ronald A. Morton, Jr, MD, Chief Medical Officer of GTx. "By increasing muscle and decreasing fat, Ostarine appears to improve levels of glucose and insulin and to reduce insulin resistance. These data suggest Ostarine may have a beneficial impact on prediabetic conditions and potentially diabetes, which, if validated in later studies, could provide the basis for our seeking expanded indications for Ostarine."
"It would be clinically meaningful and exciting if Ostarine is shown to have an effect of similar magnitude in chronic kidney disease patients where diabetes and prediabetes are highly prevalent," said T. Alp Ikizler, MD, Associate Professor of Medicine at Vanderbilt University School of Medicine.
GTx is planning to initiate a Phase IIb clinical trial evaluating Ostarine for the treatment of chronic kidney disease muscle wasting by the end of the year 2007. Diabetes is a highly prevalent comorbidity among patients with chronic kidney disease. Nearly one half of treated Stage 3 and 4 chronic kidney disease patients are diabetic, and the majority of remaining patients are prediabetic. Testing Ostarine in this population will allow GTx to gather additional information about the effect of Ostarine on glucose, insulin and insulin resistance in diabetics or people at risk for diabetes.
Data from the Phase II clinical trial of Ostarine are being highlighted at the GTx Analyst Day meeting being held today from 11 a.m. to 2 p.m. at the Loews Regency Hotel in New York City. During the meeting, GTx also will provide information about its clinical development plans and commercialization strategy for Ostarine, the company's first-in-class selective androgen receptor modulator (SARM).
In the three month Phase II clinical trial in which patients with diabetes or obesity (BMI greater than 30) were excluded, subjects treated with Ostarine 3 mg (n=23) had on average an 11% decline in fasting blood glucose (p less than 0.001), a 17.6% reduction in insulin levels (p=0.043), and a 26.8% reduction in insulin resistance (HOMA-IR) (p=0.037), when compared to their baseline measurements. Improvements in insulin resistance were more apparent among a small subset of prediabetic (fasting blood glucose of 100 - 125 mg/dL) patients (n=5) treated with Ostarine 3 mg in whom the mean fasting blood glucose declined by 17.4%, insulin levels reduced by 29.4%, and insulin resistance decreased by 41.3%.
Improvements in insulin resistance among subjects receiving the 3 mg dose provide additional supporting evidence of the anabolic activity of Ostarine. The resulting changes in body composition (increased muscle and decreased fat) with Ostarine treatment appear to have a beneficial impact on insulin resistance. These data compare favorably with results of clinical trials using FDA approved diabetic drugs in a prediabetic population. For example, in a one year study (the DREAM study), prediabetic patients taking rosiglitazone 8 mg evidenced a decline in fasting blood glucose of 9% from their baseline measurements (Lancet, 2006). Similarly, in prediabetic patients taking glipizide 2.5 mg for 6 months, the mean fasting blood glucose decreased by 4 percent, insulin declined by 17%, and insulin resistance reduced by 35% (Erikson JG et al, 2006). In prediabetic patients taking metformin 1.7 g for 16 weeks, fasting blood glucose declined by 6%, insulin decreased by 29%, and the calculated insulin resistance decreased by approximately 39% (Bulcao C et al, 2007).
"The data from our Phase II clinical trial provide more evidence that Ostarine is having the desired anabolic effect," said Ronald A. Morton, Jr, MD, Chief Medical Officer of GTx. "By increasing muscle and decreasing fat, Ostarine appears to improve levels of glucose and insulin and to reduce insulin resistance. These data suggest Ostarine may have a beneficial impact on prediabetic conditions and potentially diabetes, which, if validated in later studies, could provide the basis for our seeking expanded indications for Ostarine."
"It would be clinically meaningful and exciting if Ostarine is shown to have an effect of similar magnitude in chronic kidney disease patients where diabetes and prediabetes are highly prevalent," said T. Alp Ikizler, MD, Associate Professor of Medicine at Vanderbilt University School of Medicine.
GTx is planning to initiate a Phase IIb clinical trial evaluating Ostarine for the treatment of chronic kidney disease muscle wasting by the end of the year 2007. Diabetes is a highly prevalent comorbidity among patients with chronic kidney disease. Nearly one half of treated Stage 3 and 4 chronic kidney disease patients are diabetic, and the majority of remaining patients are prediabetic. Testing Ostarine in this population will allow GTx to gather additional information about the effect of Ostarine on glucose, insulin and insulin resistance in diabetics or people at risk for diabetes.
