Biotech Values

[rfj1862]

RPRX

I can't emphasize how huge this is, and as you know I'm not given to exaggeration. At least I hope I'm not

In my opinion, this is all that's needed for RPRX to get bought.

Improves my day after JAV.


Repros Reports That Patients Exposed to Proellex For Up To Six Months Demonstrated A Benign Endometrium Based On Biopsy

THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX) today released the endometrial biopsy findings from its three and six month studies of Proellex™ in the treatment of uterine fibroids and endometriosis respectively. The clinical study results of efficacy and top-line safety were reported in April and June 2007 and in both instances unequivocal efficacy was demonstrated in the treatment of both conditions with reduction of pain associated with endometriosis and reduction of bleeding in uterine fibroids.

Endometrial biopsies were done at baseline before treatment and after treatment in two different studies: in 26 women (67% of study participants) with endometriosis exposed to 12.5, 25, or 50 mg Proellex for six months and: in 39 women (31% of the study participants) with uterine fibroids exposed to placebo, 25, or 50 mg Proellex for three months.

Repros had reached agreement with the FDA that the primary endpoint of the endometrial pathology interpretation would utilize the WHO1 endometrial hyperplasia classification with a progressive scale of diagnoses from benign and disordered proliferative endometrium, through four types of endometrial hyperplasia, to carcinoma. A secondary end point was the identification of presence or absence of an endometrial polyp. A prospective protocol was also submitted to the FDA whereby the tissues would be read in parallel with an additional diagnostic schema, the Endometrial Intraepithelial Neoplasia (EIN)2 classification.

A panel of three leading gynecological pathologists was retained to read all of the tissues utilizing both diagnostic schemas. After the blinded pathology reads were completed the panel met to discuss their impressions of the process and any potential administrative, logistic or quality of materials issues. In addition they each gave their overall impressions of the histology before being unblinded. A consensus primary end point result was determined for each specimen by majority (two or more of three pathologists agree), or in the event of all pathologists disagreeing the "worst" diagnosis of the three was assigned. Analysis of the data was performed to show the predominant primary diagnosis. A correlation of the WHO and EIN consensus results was performed.

Histology Results

Prior to unblinding at the pathology panel debriefing meeting on July 21, 2007, blinded data listings were reviewed to decide if there was a need to re-examine any of the materials. This was judged not to be necessary and unblinding proceeded.

The results from both the WHO and EIN interpretations showed a consensus primary diagnosis in all Proellex treated subjects of benign endometrium, without any hyperplasias, EIN, or carcinomas. The correlation of the primary diagnosis of the EIN with the WHO reads at baseline was 1.00 (p < .0001) and at the end of treatment was 0.911 (p < .0001) indicating near perfect agreement of the two instruments. The results were in general no different between the subjects with endometriosis or uterine fibroids or the subjects exposed for three or six months or to different doses.

There was also consensus among the pathology panel on the absence of endometrial polyps in all of the specimens read by the WHO classification.

Additional secondary findings within the “benign” category were noted by the pathologists. Most prominent were the presence of non-uniform cystic dilatation of glands similar to the histological pattern recently described for women treated with other Progesterone Receptor Modulators (PRMs) such as asoprisnil, mifepristone and CBD 2914 (VA2914)3,4,5. The glandular epithelium within these cysts varied in appearance, but contained non-physiologic combinations of poorly developed secretory activity, dying cells (apoptotic bodies) and rare mitoses. Other cystic glands were lined by inactive epithelium. The pathologists described this constellation of cysts and epithelial findings as “novel,” noting that they are sufficiently different from what has been seen in clinical practice that their long term behavior cannot be precisely predicted without performing serial biopsies in future extended studies.

Dr. Andre van As, Chief Medical Officer of Repros commented that “Although these histology results are from a limited group of women with endometriosis and uterine fibroids, they are reflective of up to six months of treatment over a range of three doses. With the end of treatment diagnoses being that of benign endometrium in all of the women biopsied, we feel confident that our recently described treatment paradigm of sequential four month treatment cycles each followed by a drug holiday, in order to refresh the endometrium, may further enhance the safety of Proellex in the long term.”

Joseph Podolski, President and CEO of Repros, added, “Both endometriosis and uterine fibroids represent an un-served need in the arena of woman’s health and these supplementary safety data are very encouraging. No approved drug therapies in this class of compounds (PRMs) are available for these indications, and we strongly believe that Proellex, with the efficacy and safety we reported earlier, together with the results reported here, represents a significant advance to the medical approach of the long-term treatment and management of these difficult to treat conditions.”

Repros intends to continue to perform endometrial biopsies in all of their future studies with Proellex to further extend the understanding and significance of the histological changes observed in longer term exposure to this compound.