|
|
[Definitie:] "An ergogenic aid is any substance or phenomenon that enhances performance."
(Wilmore and Costill) 
|
|
|
||
|
||
|
0 7 - 0 9 - 2 0 0 5 GTx, Inc. Announces Positive Clinical Results and Development Plans for Ostarine
PRNewswire-FirstCall GTx, The Men's Health Biotech Company, announced today that results from its Phase I clinical trials for ostarine, its second selective androgen receptor modulator (SARM), were consistent with anabolic activity without evidence of unwanted androgenic side effects on prostate and skin sebaceous glands. GTx intends to begin a Phase II clinical trial of ostarine for the treatment of muscle wasting associated with burns during the fourth quarter of 2005. "We are excited with the outcome of our Phase I clinical trials of ostarine. Now that ostarine is poised to enter Phase II clinical trials, it becomes our lead SARM compound," said Mitchell Steiner, MD, chief executive officer of GTx. "Results from our recently completed multiple-ascending dose clinical trial have allowed us to pick doses of ostarine to advance into Phase II clinical trials. We have also zeroed in on developing ostarine for muscle wasting associated with an acute condition, burns, for which we believe ostarine fills an unmet medical need and which may provide us with an efficient path to market. We remain excited by other, broader market possibilities for ostarine, such as muscle wasting associated with andropause, and we intend to initiate a second Phase II clinical trial of ostarine for this indication in the first half of 2006." About Ostarine Ostarine is a non-steroidal, oral SARM, all rights to which are held by GTx. GTx believes that ostarine has the potential to treat muscle wasting associated with chronic conditions, such as end-stage renal disease, frailty and andropause, as well as muscle wasting associated with acute conditions, such as burns. Ostarine is the second SARM that GTx has brought from discovery into clinical trials. GTx also discovered andarine, a SARM that GTx and its collaborator, Johnson & Johnson's subsidiary, Ortho Biotech Products L.P., are developing to treat cancer cachexia. Planned Phase II Clinical Trials for Ostarine GTx plans to initiate Phase II clinical trials of ostarine first for muscle wasting associated with burns because acute indications have a relatively expeditious and defined clinical development and regulatory pathway. Burn patients are hypermetabolic and lose significant lean body weight, which adversely affects their healing and recovery. GTx expects to begin its Phase II clinical trial of ostarine for muscle wasting associated with burns in the fourth quarter of 2005. Studies have already established proof-of-concept for the use of anabolic agents in the treatment of burns. Because ostarine has a long half life (24 hours) and provides levels of circulating androgens unattainable with anabolic steroidal agents, GTx believes that this selective, potent, non-steroidal anabolic agent would be an important step forward in the treatment of burn patients. "We believe that the treatment of burn patients represents an excellent first path for GTx to pursue for ostarine," said Dr. Steiner. "A powerful anabolic agent without unwanted steroidal side effects could help speed the recovery of burn victims. For GTx, the treatment of burn patients offers a relatively expeditious route to market for its lead SARM." GTx plans to continue clinical development of ostarine for chronic muscle wasting due to low testosterone in aging men (a condition also known as andropause). Between 30 and 60 years of age, men on average gain a pound of fat and lose a half pound of muscle, and muscle loss accelerates after age 60. This loss of muscle mass can lead to frailty and loss of independence. GTx plans to initiate Phase II clinical testing for the treatment of andropause during the first half of 2006. About Ostarine's Phase I Multiple Ascending Dose Clinical Trial Results The Phase I multiple-ascending dose clinical trial evaluated the safety, tolerability and specific pharmacodynamic characteristics of ostarine in a double-blind, placebo-controlled study in 48 healthy male volunteers, 18-45 years of age, and 12 elderly males with truncal obesity, who averaged 68 years of age. Safety and pharmacodynamic measurements were taken at the beginning of the study and after 14 days of daily oral dosing. These measurements included routine blood chemistry and hematology, sex hormones and gonadotropins, serum prostate specific antigen, metabolic markers of bone and muscle, cutaneous sebum analysis and DEXA scanning for body composition. Ostarine is designed to have anabolic building activity without unwanted androgenic side effects on prostate and skin sebaceous glands. Overall, clinical laboratory values and hormonal effects determined from the study were consistent with anabolic activity. Comparisons of DEXA assessments from the beginning of the study to DEXA assessments after 14 days showed positive changes in body composition, with lean body mass and fat mass in study patients moving in a direction consistent with anabolic activity. Based on other tests, ostarine did not appear to have unwanted side effects on the prostate or the skin. GTx believes that these observations support the potential ability of ostarine to selectively modulate androgen receptors in a tissue-specific manner. There were no drug-related serious adverse events related to ostarine in the clinical trial. Doses that were found to be safe in this study were selected to enter Phase II testing later this year. About GTx GTx is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics for cancer and serious conditions related to men's health. GTx's lead drug discovery and development programs are focused on small molecules that selectively modulate the effects of estrogens and androgens, two essential classes of hormones. GTx, headquartered in Memphis, Tenn., currently has four clinical programs. GTx is developing ACAPODENE(R) (toremifene citrate), a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: (1) a pivotal Phase III clinical trial for the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer and (2) a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with precancerous prostate lesions. In its third clinical program, GTx is developing ostarine for the treatment of muscle wasting associated with acute conditions such as burns and chronic conditions such as andropause. GTx expects to begin Phase II clinical trials of ostarine for muscle wasting associated with burns in the fourth quarter of 2005 and for andropause during the first half of 2006. In its fourth clinical program, GTx and its collaborator, Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson, are developing andarine, another one of GTx's SARMs, for the treatment of cancer cachexia. GTx is working with Ortho Biotech to plan a Phase II clinical trial of andarine. 1 6 - 0 5 - 2 0 0 6 GTX Inc. Starts Ostarine Mid-Stage Trial
AP
MEMPHIS, Tenn. — Biotech company GTX
The trial will evaluate the drug's safety and its ability to build muscle and promote bone in 120 elderly men and postmenopausal women.
Ostarine, a first-in-class drug, is a selective androgen receptor
modulator, or SARM.
Mitchell S. Steiner, The company, which has all rights to ostarine, expects to report clinical data in the second half of the year. GTX develops therapeutics for cancer and serious conditions related to men's health. Shares rose 65 cents, or 7.6 percent, to $9.20 on the Nasdaq. 0 9 - 1 2 - 2 0 0 6 GTx Announces That Ostarine Achieved Primary Endpoint Of Lean Body Mass And A Secondary Endpoint Of Improved Functional Performance
GTx, Inc.
GTX, the Men's Health Biotech Company, today announced that ostarine, a first-in-class selective androgen receptor modulator (SARM), met its primary endpoint in a Phase II proof of concept double blind, randomized, placebo controlled clinical trial in 120 subjects (60 elderly men and 60 postmenopausal women).
Without a prescribed diet or exercise regimen, all subjects treated with ostarine had a dose dependent increase in total lean body mass (muscle), with the 3 mg cohort achieving an increase of 1.3 kg compared to baseline and 1.4 kg compared to placebo (p<0.001) after three months of treatment.
Treatment with ostarine also resulted in a dose dependent improvement in functional performance measured by a stair climb test, with the 3 mg cohort achieving a clinically significant improvement in both speed (p=0.006) and power (p=0.005).
Ostarine continued to demonstrate a favorable safety profile, with no serious adverse events reported. Ostarine also exhibited tissue selectivity with beneficial effects on lean body mass and performance and with no apparent change in measurements for serum PSA (prostate), sebum production (skin and hair), or serum LH (pituitary) compared to placebo.
The Phase II clinical trial evaluated four doses of ostarine (0.1 mg, 0.3 mg, 1 mg, and 3 mg) versus placebo for three months in 60 elderly men (average age 66 years) and 60 postmenopausal women (average age 63 years). The trial was conducted in five clinical sites in the United Kingdom and Germany.
A summary of the topline data is as follows:
-- Among females (n=56), ostarine treatment resulted in a dose dependent increase in LBM with the 3 mg dose having an increase of 1.7 kg compared to baseline and an increase of 1.4 kg compared to placebo (p=0.02).
-- Among males (n=58), treatment with a 1 mg dose of ostarine resulted in a LBM increase of 0.7 kg compared to baseline and an increase of 1.2 kg compared to placebo (p=0.03), and treatment with a 3 mg dose of ostarine resulted in an increase of 1.0 kg compared to baseline and an increase of 1.4 kg compared to placebo (p=0.005).
-- Total tissue percent fat decreased compared to placebo in a dose dependent fashion and achieved statistical significance at the 1 mg dose (p=0.02) and 3 mg dose (p=0.006) of ostarine.
Total fat mass was lower in subjects receiving either the 3 mg or 1 mg ostarine dose, although not at a statistically significant level (p = 0.08 for both doses). For subjects receiving the 3 mg ostarine dose, total fat on average declined 0.6 kg compared to placebo.
The site of fat loss differed among male and female subjects, with males losing fat primarily from the trunk and abdomen, and females losing fat primarily from the thighs and legs.
-- In this short trial, ostarine had no apparent effect on bone mineral density, and bone turnover markers results were mixed. In preclinical in vitro and in vivo models, ostarine demonstrated both anabolic and antiresorptive activity on bone. A longer clinical study is necessary to demonstrate the actual effects of ostarine on bone.
-- Ostarine continued to demonstrate a favorable safety profile, with no serious adverse events reported.
-- At the end of three months, no subject had clinically meaningful levels in liver enzyme tests. However, one female discontinued the study per protocol due to elevated liver enzymes which returned to baseline.
-- Ostarine treatment resulted in a dose dependent decrease in both LDL and HDL cholesterol levels, with the average LDL/HDL ratio for all doses tested remaining in the low cardiovascular risk category.
-- Ostarine treatment resulted in no apparent effect on serum PSA (prostate), sebum production (skin and hair), or serum LH (pituitary).
|
|
|
