October 29, 2009 / 12:46 AM / 10 years ago

UPDATE 1-Repros amends agreement over Proellex license

* Proellex is on clinical hold due to safety reasons

* Clinical hold put license under risk

NEW YORK, Oct 28 (Reuters) - Repros Therapeutics Inc RPRX.O signed an amendment with the National Institutes of Health (NIH) to its license for Proellex, the company’s experimental drug for uterine fibroids on hold for safety reasons.

The amendment revises the existing milestones and dates for performance to provide additional time to lift the clinical hold or select a second generation molecule for further development from the family of anti-progestational agents covered by the license, the company said on Wednesday.

Woodlands, Texas-based Repros, which focuses on developing treatments for male and female reproductive disorders, announced in early August that it had suspended dosing all patients in its Proellex clinical trials.

The Food and Drug Administration (FDA) notified Repros that the Proellex program was placed on clinical hold due to the observation of increased liver enzymes in a number of patients treated with Proellex.

Repros said the amendment gave the company enough time to determine whether it is possible to lift the clinical hold on Proellex.

The clinical hold on Proellex affected a variety of benchmark milestones used by the NIH to enforce the license. (Reporting by Juan Lagorio; Editing Bernard Orr)

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