GTx Announces Additional Top Line Phase III Data Demonstrating Toremifene Citrate 80 mg Reduced Hot Flashes in Men with Prostate Cancer on Androgen Deprivation Therapy
Monday March 3, 6:00 am ET
The Most Common Symptomatic Side Effect Experienced by Men on ADT is Hot Flashes
MEMPHIS, Tenn.--(BUSINESS WIRE)--GTx, Inc. (NASDAQ: GTXI - News) today announced that toremifene citrate 80 mg reduced hot flashes in men with prostate cancer on androgen deprivation therapy (ADT), a key secondary endpoint of the Phase III clinical trial evaluating toremifene citrate 80 mg for the treatment of multiple side effects of ADT for advanced prostate cancer.
In an analysis of hot flashes in a subset of patients in the Phase III ADT clinical trial experiencing six or more hot flashes per day at baseline and not being treated with megestrol acetate (Megace®), toremifene citrate 80 mg treatment reduced the number of hot flashes by an average of 4.7 hot flashes per day compared to placebo patients who had a reduction of 1.6 hot flashes per day (p=0.03). The reduction of hot flashes in patients treated with toremifene citrate 80 mg was durable for at least 12 months.
“Hot flashes are the most common and bothersome symptomatic side effect of ADT. Up to 80% of men on ADT report being troubled by hot flashes, which are often cited as a cause of noncompliance with hormone therapy,” said Matthew R. Smith, MD, PhD, Director, Genitourinary Medical Oncology, Massachusetts General Hospital Cancer Center, Associate Professor of Medicine at Harvard Medical School, and Lead Principal Investigator of the Phase III ADT clinical trial.
GTx earlier announced data from the Phase III ADT clinical trial demonstrating that toremifene citrate 80 mg reduced new morphometric vertebral fractures, the primary endpoint of the trial, and met other key endpoints, including increasing bone mineral density, improving lipid profiles, and ameliorating gynecomastia.
“The Phase III ADT clinical trial data are important because they demonstrate the potential for toremifene citrate 80 mg as a treatment for multiple side effects of ADT, reducing fractures and improving lipid profiles while also treating symptomatic side effects such as hot flashes and gynecomastia,” added Dr. Smith.
“These hot flashes data provide additional confirmation that the multiple estrogen related side effects of androgen deprivation therapy for prostate cancer are treatable by toremifene citrate 80 mg, which binds to and selectively modulates the estrogen receptor depending on tissue type,” said Mitchell S. Steiner, MD, Chief Executive Officer of GTx.
Toremifene citrate 80 mg had a favorable safety profile and was well tolerated. Among the most common adverse events that occurred were joint pain (treated 7.3%, placebo 11.8%), dizziness (treated 6.3%, placebo 5.0%), back pain (treated 5.9%, placebo 5.2%), and extremity pain (treated 5.0%, placebo 4.4%).
Conference Call
There will be a conference call today at 9:00 a.m. Eastern Time. GTx and Dr. Smith will discuss the top line results of the toremifene citrate 80 mg Phase III ADT clinical trial. To listen to the conference call, please dial 866-770-7051 from the United States or Canada or 617-213-8064 from outside North America. The access code for the call is 82373052. A playback of the call will be available from approximately 11:00 a.m., Eastern Time today through March 10, 2008 and may be accessed by dialing 888-286-8010 from the United States or Canada or 617-801-6888 from outside North America, and referencing reservation number 39648500. Additionally, you may access the live and subsequently archived webcast of the conference call from the Investor Relations section of the Company’s website at gtxinc.com. |
