GTx Announces Upcoming Presentation of Toremifene Citrate 80 mg Phase III ADT Clinical Trial Results
Tuesday, April 08, 2008 6:11 AM
Symbols: GTXI

GTx, Inc. (NASDAQ: GTXI) today announced that the results of the Phase III clinical trial evaluating toremifene citrate 80 mg for the treatment of multiple side effects of androgen deprivation therapy (ADT) for advanced prostate cancer will be presented during a late breaking oral presentation at the 2008 Annual Meeting of the American Association for Cancer Research being held in San Diego April 12 - 16.

Matthew R. Smith, MD, PhD, Director, Genitourinary Medical Oncology, Massachusetts General Hospital Cancer Center, Associate Professor of Medicine at Harvard Medical School will present results of the Phase III ADT clinical trial.

• “A Phase III randomized controlled trial of toremifene to prevent fractures and other adverse effects of androgen therapy in men with prostate cancer.” Abstract number LB-241

• Tuesday, April 15, 2008, 11:30 – 11:50 a.m. Pacific Time

• Ballroom 20D, San Diego Convention Center

About GTx

GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical conditions.

GTx is developing ACAPODENE® (toremifene citrate), a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: first, a pivotal Phase III clinical trial evaluating toremifene citrate 80 mg for the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer, and second, a pivotal Phase III clinical trial evaluating toremifene citrate 20 mg for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN.

GTx licensed from Orion Corporation the rights to toremifene citrate for all indications worldwide, except breast cancer outside the United States. In 2006, GTx and Ipsen Group entered into a development and collaboration agreement for toremifene citrate in all indications except breast cancer for Europe and the Commonwealth of Independent States (CIS). Ipsen is the leading marketer of ADT (triptorelin) in Europe. Under the agreement, Ipsen will be responsible for filing for marketing approval with regulatory authorities and commercializing toremifene citrate in Europe and CIS. GTx will file for marketing approval and, if approved, plans to commercialize toremifene citrate 80 mg in the United States.

GTx has formed a strategic collaboration with Merck & Co., Inc.


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