UPDATE 1-Repros to submit trial design for oral Proellex

Mon Jul 16, 2012 11:27am EDT

* FDA may update status on drug to "partial clinical hold"

* Co to submit the study design in a few days

July 16 (Reuters) - Repros Therapeutics Inc said it will submit to regulators in the next few days a design for a mid-stage trial of an oral version of its tumor drug, Proellex, that could lead to a partial lift of a clinical hold.

The U.S. Food and Drug Administration asked Repros in May to submit safety data from a completed mid-stage trial on the drug. The FDA put a clinical hold on oral Proellex in 2009 due to liver toxicity issues associated with high doses.

In the planned mid-stage trial, doses of 6 and 12 mg will be tested using accepted pain endpoints, the company said in a statement.

Repros is testing Proellex to treat symptoms of uterine fibroids, or non-cancerous tumors in the womb, and endometriosis, a disorder that can lead to infertility in women.

Shares in the Woodlands, Texas-based company were up 5 percent at $8.50 on the Nasdaq.

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