PregLem initiates Ph III uterine myoma trial

PregLem SA, a Swiss biopharmaceutical company specializing in reproductive medicine, has initiated an international Phase III trial program for PGL4001 (ulipristal) in symptomatic uterine myoma, a common benign solid tumor of the genital tract in women of reproductive age.

In a previous Phase II study, the orally-active, selective progesterone receptor modulator was well tolerated and effective both in immediately stopping uterine bleeding, a major symptom associated with the condition, and in reducing myoma volume. Results of the Phase III trials are expected in 2010.

The program is composed of two separate late-stage evaluations involving a total of 540 patients and being carried out in parallel in a total of 14 countries.