GTx, Inc. (Nasdaq: GTXI), today announced that Phase III data from a bone mineral density interim analysis and from a lipid interim analysis will be presented in separate podium sessions on February 23rd at the American Society of Clinical Oncology Prostate Cancer Symposium. Both analyses were conducted in the first 197 men to complete one year of treatment in the Phase III clinical trial evaluating ACAPODENE® (toremifene citrate) 80 mg for the treatment of multiple serious side effects of androgen deprivation therapy (ADT) for advanced prostate cancer.
Dr. S. Bruce Malkowicz, Professor of Urology at the University of Pennsylvania School of Medicine, will present the bone mineral density interim data, and Dr. Matthew Smith, Associate Professor at Massachusetts General Hospital Cancer Center, will present the lipid interim data. The presentations will be delivered in an Oral Abstract Session beginning at 1 p.m. on February 23rd in the Osceola Ballroom at the Gaylord Palms Resort & Conference Center in Orlando, Florida.
GTx has been notified that these presentations have been selected to be part of an ASCO press briefing the morning of February 23rd.
GTx is conducting the Phase III ADT clinical trial in approximately 1,400 patients at nearly 150 clinical sites in the United States and Mexico. The primary endpoint of the pivotal Phase III ADT clinical trial is a reduction in vertebral morphometric fractures. Secondary endpoints include improvements in BMD, hot flashes, gynecomastia, and lipid profiles. The last patient will complete the trial at the end of November, 2007. GTx will then evaluate the data and prepare it for public release. If the data demonstrate a significant fracture benefit, GTx will file a new drug application in 2008.
I'm keeping an eye out on this stock, and will post what data I can find that could allude to positive or negative results.
GTXI is unchanged in today's trading at $20.55 per share.
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1 comment:
Well said.
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