In the published report, the effects of Proellex were evaluated in a rat model wherein breast tumors are induced via a known carcinogenic compound. In the study, the hormone progesterone was shown to increase the number of growing tumors. Conversely, the administration of Proellex exhibited an inhibitory effect resulting in not only a regression of the size of tumors but also a suppression of the development of new tumors.
Approximately 200,000 American women were diagnosed with breast cancer in 2005. Women whose primary lesions contain both estrogen and progesterone receptors are typically treated with anti-estrogens or aromatase inhibitors which inhibit the synthesis of estrogen. Progestins (progesterone like compounds) have been shown to increase the incidence of spontaneous mammary tumors in dogs and mice. Reports from the Women's Health Initiative showed a small but clearly higher risk of breast cancer in women taking hormone replacement therapy that included a progestin.
In the past, anti-progestins such as Proellex have been postulated to be of potential benefit in the treatment of breast cancer. Unfortunately, most of the drugs in the class have significant anti-glucocorticoid activity which would prohibit their chronic use. In human studies conducted by Repros to date, Proellex has exhibited little anti-glucocorticoid activity in humans.
Proellex may rep resent a new approach to the treatment of breast cancer in women that are refractory to either anti-estrogen or aromatase inhibitor therapy. In addition, the animal data discussed in the paper suggests that Proellex may have the potential to be developed for the prevention of breast cancer or in adjuvant therapy in combination with already approved anti-estrogen or aromatase inhibition based therapies.
Dr. Ronald Wiehle, VP of R&D at Repros, noted, "We are pleased with the performance of Proellex in clinical trials for the non-life-threatening conditions of endometriosis and uterine fibroids. In addition to Proellex providing real benefit to women suffering from these debilitating conditions, the drug has been remarkably well tolerated. We now have peer-reviewed evidence that Proellex may also be useful in the treatment of a significant life-threatening disease. Any potential for the prevention of breast cancer, if verified, would be especially good news for women taking Proellex for endometriosis and fibroids."
Joseph Podolski, President and CEO, added, "This report represents significant findings towards the potential for a new indication for Proellex. We are well down the road of preparing a complete dossier for NDA submission for Proellex in the treatment of uterine fibroids, which is expected around the end of 2008. Though not a trivial task, this new indication could be developed with a specific focus on efficacy questions while relying heavily on our existing and growing safety data base for Proellex." He further commented, "Our developmental portfolio of indications is very full at this time. We believe the opportunity to find a partner in the oncology arena for the breast cancer indication represents a great opportunity for the Company. We therefore plan to explore a potential collaborative relationship with one of the major oncology companies for the breast cancer indication."
About Repros Therapeutics Inc.
Repros is engaged in the development of pharmaceutical products that address conditions of the male and female reproductive systems. Proellex, the Company's lead compound, a PRM (progesterone receptor modulator) has recently completed a successful U.S. three-month Phase 2 clinical trial for the treatment of uterine fibroids, a condition that affects numerous women of childbearing age in the United States and results in a significant number of hysterectomies each year. Proellex has recently completed a six-month European Phase 1/2 study for the treatment of endometriosis, a condition that affects approximately 5.5 million women in the United States and Canada. Androxal(TM), the Company's other program in late clinical development, is designed to restore normal testosterone production by the testes and has recently completed a six-month U.S. non-pivotal Phase 3 clinical trial for the treatment of testosterone deficiency in men due to secondary hypogonadism. According to industry sources, approximately 13 million men in the United States experience testosterone deficiency. The Company is planning meetings with the FDA for all three programs to lay out the remaining clinical program pathway required before a New Drug Application may be submitted for each product candidate.
For more information, please visit the Company's website at http://www.reprosrx.com.
Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros' ability to have success in the clinical development of its technologies, the timing of enrollment in such clinical studies and the accuracy of such studies, Repros' ability to raise additional capital on acceptable terms or at all, and such other risks which are identified in the Company's Annual Report on Form 10-K for the year ended December 31, 2006, and Repros' Quarterly Report on Form 10-Q for the quarter ended March 31, 2007, as they may be updated by the Comp any's Exchange Act filings from time to time. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Repros Therapeutics Inc., The Woodlands
Joseph S. Podolski, 281-719-3447
President & CEO