Toremifene 20 mg: Investigational Therapy for Prostate Cancer Prevention in High Risk Patients
GTx is evaluating toremifene citrate 20 mg, a selective estrogen receptor modulator, or SERM, for the prevention of prostate cancer in high-risk men.
Prostate cancer is the second leading cause of cancer deaths among men in the United States, with an expected 30,000 deaths each year.1 One of the determinants of a patient’s risk for developing prostate cancer, independent of age, race and family history, is the presence of the precancerous lesion called high grade prostatic intraepithelial neoplasia (PIN). More than 40% of high grade PIN patients will progress to prostate cancer within three years of diagnosis and up to 80% within eight years.2,3 With no FDA approved therapies for high grade PIN today, the standard of care for these patients is to continue to monitor the progression of high grade PIN to cancer through serial prostate biopsies.
Prostate cancer is a hormonally mediated disease, and both testosterone and estrogen are required for its development and progression. GTx believes that by selectively blocking estrogen receptors that are responsible for prostate cell proliferation, toremifene 20 mg may be an ideal antiestrogen for chemoprevention of prostate cancer.
Phase III Clinical Trial
GTx is conducting a pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade PIN. The primary endpoint of the study is a reduction in the incidence of prostate cancer. GTx plans to conduct the final analyses of the clinical trial following the conclusion of the study in the 1st quarter of 2010.
References
1. American Cancer Society, www.cancer.org
2. Huang G et al J Urol 2005, 173:397.
3. Fleshner et al Presented at ASCO 2005 Prostate Cancer Symposium. Available at http://media.asco.org/asco/meetings_education/module/slide_video/frame.asp?eventname=gu2005&PlayThumb=0&id=501&mediaURL=/media&ServerName=media.asco.org. Accessed online January 26, 2009.