Repros' IND For The Commencement Of Phase III Studies Of Proellex(R) In The Treatment Of Anemia Associated With Uterine Fibroids Is Now Effective

Repros’ IND For The Commencement Of Phase III Studies Of Proellex(R) In The Treatment Of Anemia Associated With Uterine Fibroids Is Now Effective

February 25, 2008 – 6:52 pm | posted in Urology / Nephrology

Repros Therapeutics Inc. (NasdaqGM:RPRX) announced that the Company’s Investigational New Drug application for the study of Proellex® in the treatment of anemia associated with uterine fibroids has become effective. The Company will open the IND with two identical registration quality Phase III studies. The work has been awarded to an appropriate CRO.

This IND is based on impressive clinical findings from a subset of anemic patients in a Phase IIb trial of Proellex in the treatment of uterine fibroid symptoms we completed last year. In that study, women with hemoglobin levels of less than 11.5 g/dl improved by up to 2 g/dl, or the equivalent of two pints of blood, after three months of treatment with Proellex. Even though only approximately 15-17 patients per active treatment arm were evaluable for anemia, the improvement of hemoglobin in Proellex-treated subjects was both clinically and statistically highly significant (p 26 and glucose levels >99, an outcome not seen in the placebo or Androgel arms of this study. The second Phase 2b Androxal trial to begin in 2008 will be in men of reproductive age with low testosterone levels who want to improve or maintain fertility/sperm status. We believe Androxal will be superior to the existing drugs used to normalize testosterone as only Androxal has the property of restoring both LH and follicle stimulating hormone (FSH) levels. FSH is the pituitary hormone that stimulates testicular sperm production. It is estimated that 13 million men in the United States are testosterone deficient.

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 and release of data in such clinical studies and the accuracy of such studies, limited patient populations of clinical studies to date and the possibility that final data may not be consistent with interim data, Repros’ ability to raise additional capital in a timely manner and 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 Reports on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2007, as they may be updated by the Company’s Exchange Act filings from time to time. These documents are available on request from Repros Therapeutics or at http://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.

For more information, please visit the Company’s website at http://www.reprosrx.com.

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