Repros Therapeutics contracts three ongoing clinical studies to Pharm Olam

By E. Janene Geiss

Philadelphia, May 22 - Repros Therapeutics, Inc. said Monday that it has contracted three of its ongoing clinical studies to Pharm Olam International.

The studies include a 200-patient, U.S. phase 3 study of Androxal for the treatment of testosterone deficiency in men with secondary hypogonadism, a 150-patient, U.S. phase 2 study of Proellex in the treatment of uterine fibroids and a 40-patient, European phase 2 study of Proellex in the treatment of endometriosis, according to a company news release.

As of Friday, 149 patients in the 200-patient Androxal study have been screened at 18 active clinical sites.

Of the 149 patients, 62 were screening failures, officials said.

The primary reason for screening failure was that the testosterone levels of the individuals were not less than 300 ng/dl, indicating they did not meet the criteria required to be characterized as testosterone deficient currently used in the study.

The company said that only one patient failed screening due to a high leuteinizing hormone level, which would indicate hypogonadism due to a primary or a testicular dysfunction. This observation supports Repros' belief that the majority of men with low testosterone are hypogonadal due to a pituitary effect, the effect that the company's drug is designed to treat, officials said.

There have been no serious adverse events noted to date. The company said it believes it will be able to report top-line results from a three-month data point before year-end.

As of Friday, 63 patients in the 150-patient Proellex uterine fibroid study have been screened at 17 active clinical sites.

To date there have been six screen failures, officials said.

The primary screening failure has been excessive weight or body mass index. The study has recruited slower than the Androxal study primarily due to the fact that some of the screened women are unwilling to replace their current use of oral contraceptives with double barrier contraception as required by the study.

There have been no serious adverse events noted to date. The company said it believes it will be able to report top-line results from a three-month data point before year-end.

As of Friday, 11 patients in the 40-patient Proellex endometriosis study have been screened at the two active clinical sites.

So far, there have been no screen failures. The slower-than-expected recruitment for the study is primarily due to the fact that some of the screened women do not want to use contraception during the trial since they are hoping to get pregnant as soon as possible.

The study requires the use of double barrier contraception during the course of the trial. There have been no serious adverse events noted to date. The company said it believes it will be able to report top-line results from the three-month data point before year-end.

"[Pharm Olam] has assured us that last patient on drug for each of the studies should occur before Sept. 1, and that they will have top-line data to us before year-end," Joseph S. Podolski, president and chief executive officer of Repros, said in the release.

Based in The Woodlands, Texas, Repros is a pharmaceutical company focused on developing products that address male and female reproductive systems.

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