UPDATE 1-Repros to submit trial design for oral Proellex
* 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.
- Tweet this
- Share this
- Digg this