Strong Ph II data for Org 36286

Dutch drugmaker Organon reported strong Phase II study results which it says provide initial evidence that a single subcutaneous injection of its drug candidate Org 36286 is effective in sustained multifollicular development for up to an entire week in patients undergoing controlled ovarian stimulation for intracytoplasmic sperm injection or in vitro fertilization.

The Phase II controlled dose-finding study designed to investigate the response to three different doses of Org 36286 (up to 180mcg, demonstrated that a single subcutaneous injection followed by a fixed daily dose of Organon's contraceptive Puregon (follitropin beta injection) from day eight onwards induced multiple follicular growth at all doses: a mean of 5.2 oocytes were retrieved from the group given a single 60mcg injection, 10.3 oocytes from the 120mcg-group, and 12.5 oocytes from those on 180mcg.

According to the firm, the trial was conclusive in that it demonstrated a significant dose-response for the number of oocytes recovered. Serum levels of estradiol and inhibin-B also increased in a dose-proportional way. No safety concerns arose during the study, Organon noted.