GTx, Inc. Initiates Phase I Clinical Trial for Its Second SARM Ostarine
MEMPHIS, Tenn., February 01, 2005 /PRNewswire-FirstCall/ -- GTx, a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics for serious men's health conditions, today announced that it has initiated a Phase I clinical trial for ostarine, GTx's second selective androgen receptor modulator (SARM) compound to be tested in clinical trials.
"We are very excited about the promising preclinical ostarine data and are pleased to initiate this clinical trial," stated Mitchell Steiner, M.D., Vice Chairman and CEO of GTx. "This shows that we have the proven ability to create compounds in the laboratory and move them into the clinic as we continue to position GTx as the lead SARM company."
The Phase I study will evaluate the safety, tolerability and pharmacokinetic profile of ostarine using a single ascending dose, double- blind, placebo-controlled design in healthy volunteers.
Ostarine is a nonsteroidal SARM that is designed to have positive anabolic effects without having an impact on the prostate and is being developed for andropause as well as other conditions associated with aging, such as sarcopenia. Sarcopenia is defined as the loss of muscle mass associated with aging leading to frailty and loss of independence.
As people age they undergo hormonal and metabolic changes. Each year after age 30 people gain an average of a pound of fat every year and lose a half a pound of muscle every year. Thus, men may lose 50% of muscle between the ages of 30 and 90. Muscle provides strength and endurance, supports the skeletal system and helps protect the body from illness. Loss of muscle can cause frailty, loss of independence, and worsens other conditions such as osteoarthritis and osteoporosis. There are 17 million Americans alive over the age of 75 who suffer from sarcopenia and currently there are no approved treatment options available.
GTx's SARM Discovery Program
GTx believes that the ability to selectively target and modulate the androgen receptor will allow the development of many new drugs that are crucial for men's health. In fact, different compounds within the SARM class have demonstrated in preclinical studies unique pharmacologic activities, with varying effects on endocrine feedback, prostatic stimulation, spermatogenesis, muscle growth, bone growth and sexual behavior, highlighting the untapped potential of these novel drugs for treatment of other diseases, including benign prostatic hyperplasia (BPH), male infertility, and low libido.
GTx is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics for serious men's health conditions.
GTx's drug discovery and development programs are focused on small molecules that selectively modulate the effects of estrogens and androgens.
GTx currently has four clinical programs. In two of the clinical programs, the company is developing ACAPODENE(TM), its most advanced product candidate, through clinical trials for two separate indications: (1) a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men and (2) a pivotal Phase III clinical trial for the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer. [Link]
In its third clinical program, GTx and its partner, Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson, are developing andarine, a selective androgen receptor modulator (SARM), which is expected to enter a Phase II clinical trial in 2005.
In its fourth clinical program, GTx is developing its own SARM, ostarine, for andropause and other conditions related to aging, including sarcopenia.
In addition, GTx has a deep pipeline generated from its own discovery program which includes specific preclinical product candidates prostarine, a SARM, for benign prostatic hyperplasia (BPH), and andromustine, an anticancer drug, for hormone refractory prostate cancer.