On the close horizon is a new drug that will treat the many side effects of a hormone blockade (ADT). On Monday, positive results of a phase III clinical trial of toremifene citrate was released to the press. GTX Inc. (GTXI), the biopharmaceutical company that has been conducting the trial says that by this coming summer it will apply for approval of the drug with the FDA.
GTXI has indicated that toremifene citrate significantly reduced vertebral fractures as well as having positive effects on bone mineral density (BMI), lipid profiles, and gynaecomastia (breast enlargement).
Toremifene citrate also demonstrated a favorable safety profile and was well tolerated by the participants in the clinical trial.
As with all drugs there were side effects. The most common adverse events experienced in over 2% of study subjects were joint pain, dizziness, back pain, and extremity pain. Venous thromboembolic events (VTE), which included both deep venous thrombosis and pulmonary embolism, appeared in 2.4 % in the toremifene citrate 80 mg treated group and 1.02 % in the placebo group. The highest time of risk for VTEs occurred in the first year of treatment.
Those of us on ADT know how rough the treatment can become. We do have some weapons in our quiver to fight off some of the side effects, but they are not consistent in their ability to help and often pose significant risks and side effects themselves.
I look forward to learning more about toremifene citrate. Stay tuned, I will report more information as I am able to learn about it.
Joel T Nowak MA, MSW