On 5/11/09, RPRX reported that its Proellex clinical programs are progressing well and according to plan. RPRX completed enrollment of its first Pivotal Phase 3 clinical trial (ZPU-303) for the chronic treatment of uterine fibroids and expect the first Pivotal Phase 3 clinical trial for the treatment of anemia associated with uterine fibroids (ZPU-301), to be fully enrolled mid-2009, which would then lead to top-line results in each study by the end of this year. RPRX expects top-line results from its other two complementary Pivotal Phase 3 studies, ZPU-302 (anemia) and ZPU-304 (chronic symptoms), during Q1 of 2010 (1Q10).
The two New Drug Applications (NDA) for anemia associated with uterine fibroids and chronic symptoms of uterine fibroids are scheduled to be submitted to the FDA during the second half of 2010 (2H10). The endometriosis program for Proellex has reached the end of Phase 2, and it is Company's intent to discuss the results of study ZPE-201 with the FDA during an End-of-Phase II Meeting, mid-2009. Taking the feedback and input from the FDA into account, RPRX will then initiate two well-controlled Pivotal Phase 3 studies for the endometriosis indication during the second half of this year.
$7.35 (06/10/09)
