GTXi presented its toremifene data yesterday, but the April options continued to show high IVs. I couldn't think of any good reason for this, as I am expecting no news before expiration, so I sold a round of puts. So far, so good . . . anyone know if something is expected soon?
Here's the PR:
>>First Fracture Prevention Study in Men Receiving ADT for Prostate Cancer Presented at AACR Annual Meeting
Tuesday April 15, 2:30 pm ET
Phase III Clinical Trial Results Demonstrate Toremifene Citrate 80 mg Compared to Placebo Reduced Fractures and Treated Multiple Other Estrogen Related Side Effects of ADT
SAN DIEGO--(BUSINESS WIRE)--GTx, Inc. (NASDAQ: GTXI - News) announced that results of the Phase III ADT clinical trial evaluating toremifene citrate 80 mg for the treatment of multiple side effects of androgen deprivation therapy (ADT) in men who have advanced prostate cancer were presented today during a late breaking oral session at the 2008 Annual Meeting of the American Association for Cancer Research (AACR) in San Diego. Results of the Phase III ADT clinical trial demonstrate that toremifene citrate 80 mg compared to placebo built bone and prevented fractures, reduced hot flashes, and treated other estrogen related side effects of ADT.
ADT, the most common treatment for advanced prostate cancer, is a form of hormone therapy that works by reducing testosterone and estrogen. While it is successful in stopping the progression of prostate cancer, it can result in multiple estrogen related side effects, including bone loss and increased risk of fractures, hot flashes, adverse lipid changes and increased cardiovascular risk, and gynecomastia (breast pain). Studies have shown that men on ADT are three times more likely to experience a fracture than postmenopausal women, and that when they develop a fracture, their median survival rate decreases by more than three years.
“As a medical oncologist treating prostate cancer patients, I have seen firsthand how the serious side effects of ADT not only have an impact on a man’s quality of life but can also be life threatening,” 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 Investigator of the Phase III ADT clinical trial. “There are no medicines approved to treat side effects of ADT. The results of the Phase III ADT clinical trial are exciting, as they demonstrate that toremifene citrate 80 mg prevents fractures and treats other side effects of ADT.”
About the study
The two year double-blind, placebo-controlled, randomized study of 1,389 ADT patients, was conducted at approximately 150 clinical sites in the United States and Mexico. The primary endpoint was new morphometric vertebral fractures. Other key secondary endpoints included bone mineral density, lipid changes, hot flashes, and gynecomastia.
Primary endpoint
In a modified intent to treat analysis, which included all patients with at least one evaluable study radiograph and a minimum of one dose of study drug or placebo, patients receiving toremifene citrate 80 mg had approximately a 53 percent reduction in new morphometric vertebral fractures compared to placebo (p=0.03).
Other endpoints
Patients treated with toremifene citrate 80 mg compared to placebo had statistically significant increases in bone mineral density in the lumbar spine, hip, and femur skeletal sites (each p<0.001). Toremifene citrate 80 mg treatment also resulted in a decrease in total cholesterol (p=0.011), LDL (p=0.018), and triglycerides (p<0.0001), and an increase in HDL (p=0.001). There were also statistically significant improvements in gynecomastia (p=0.003). In patients experiencing 6 or more hot flashes per day at baseline who were not being treated with megestrol acetate (Megace®), toremifene citrate 80 mg was shown to reduce the number of hot flashes by an average 4.7 hot flashes per day compared to placebo patients who had a reduction of 1.6 hot flashes per day (p=0.03).
Safety
Toremifene citrate 80 mg had a favorable safety profile and was well tolerated. Among the most common adverse events that occurred in over 2% of study subjects 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%).
Venous thromboembolic events (VTE), which included both deep venous thrombosis and pulmonary embolism, were 17 (2.4 %) in the toremifene citrate 80 mg treated group and 7 (1.02 %) in the placebo group. The majority of VTEs occurred in men at high risk for a VTE including: age greater than 80 years, history of VTE, recent surgical procedure and immobilization. Excluding high risk patients over the age of 80 years and with a history of VTEs, the VTEs were 7 (1.3 %) in the toremifene citrate 80 mg treated group and 4 (1.0%) in the placebo group (p=0.38), and toremifene citrate 80 mg compared to placebo demonstrated an 80% reduction in new morphometric vertebral fractures (p=0.002).
There was no difference in prostate specific antigen (PSA) progression in patients treated with toremifene citrate 80 mg when compared with patients receiving placebo.<<
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Cheers, Tuck |
