Following the conclusion of a series of meetings with the United States Food and Drug Administration (FDA), GTx, Inc. (Nasdaq: GTXI) announced today the clinical trial design for the two Phase III Ostarine™ registration studies for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer (NSCLC).
In July, GTx will initiate the Ostarine POWER1 and POWER2 (Prevention And Treatment Of Muscle Wasting in CancER) Phase III clinical trials and, assuming enrollment for both studies is completed within one year, expects completion of the two five month studies (last patient last visit) in the fourth quarter of 2012.
"Muscle wasting, which is so common in lung cancer patients, along with the associated weakness and fatigue, can result in diminished quality of life, loss of independence, and decreased ability to tolerate and benefit from cancer treatment," said Jeffrey Crawford, MD, Chief, Division of Medical Oncology, Duke University Medical Center, and Lead Investigator of the POWER clinical trials. "A medical intervention which helps non-small cell lung cancer patients stay strong would be an important addition to the treatment armamentarium."
"As a physician specializing in elderly cancer patients, strength is not only an important determinant of a patient's quality of life, it also predicts outcomes," said Hyman Muss, MD, Professor of Medicine and Director of Geriatric Oncology at the Lineberger Comprehensive Cancer Center at the University of North Carolina. "Muscle is not only a source of strength, it is also a store of proteins the body needs to help fight cancer and to better tolerate treatment. With three efficacy studies previously showing an increase in muscle and physical function, Ostarine is a promising drug candidate to prevent muscle wasting in cancer."
In July 2011, GTx expects to initiate the Ostarine Phase III, international clinical trials, POWER1 and POWER2. In each of the placebo controlled, double blind clinical trials, 300 patients with Stage III or IV non-small cell lung cancer initiating first line chemotherapy will be randomized to placebo or Ostarine 3 mg. The studies will evaluate as co-primary endpoints the effect of Ostarine on lean body mass assessed by dual x-ray absorptiometry (DXA) and on physical function assessed by the Stair Climb Test.
"Since first reporting positive results in the Phase IIb Ostarine clinical trial in 2008, GTx has been excited about the potential for Ostarine to prevent and treat muscle wasting in cancer patients," said Mitchell S. Steiner, MD, CEO of GTx. "We now have regulatory clarity for the path forward for this important indication."
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