Org 36286 Will Reduce The Number Of Injections Needed In IVF And ICSI

Main Category: Fertility
Also Included In: Endocrinology;  Clinical Trials / Drug Trials
Article Date: 06 Oct 2006 - 0:00 PDT

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Speaking at an expert meeting in Athens marking the tenth anniversary of the launch of Puregon®, Dr Bernadette Mannaerts from Organon Global Clinical Development described a phase II controlled dose-finding study designed to investigate the response to three different doses (60, 120 or 180 micrograms) of Org 36286 given for controlled ovarian stimulation prior to IVF or ICSI. In total 233 subjects were treated with Org 36286, and 81 subjects were in the Puregon reference group. The response to treatment was measured as the number of oocytes retrieved for fertilization (1).

Dr Mannaerts reported that a single subcutaneous injection of Org 36286 followed by a fixed daily dose of Puregon from day 8 onwards induced multiple follicular growth at all doses; a mean of 5.2 oocytes were retrieved from the group given a single 60 mcg injection, 10.3 oocytes from the group given 120 mcg, and 12.5 oocytes from the group given 180 mcg. The trial was conclusive in that it demonstrated a significant dose-response for the number of oocytes recovered. Accordingly, serum levels of estradiol and inhibin-B also increased in a dose-proportional way. No safety concerns arose during the study.

Org 36286 is the first fertility hormone to reach this phase of development since the launch of Puregon, and it is also, as a new biological entity, the first of a new class of drugs with the proposed name "sustained follicle stimulants". The sustained action of Org 36286 is derived from an elimination half-life measured in this study as 66 hours. This means that the activity of Org 36286 is sustained over a much longer period than conventional hormones, which require a daily injection for adequate stimulation of the ovaries. However, as this study suggests, just one injection of Org 36286 at the beginning of the treatment phase has the equivalent effect of seven daily injections of the conventional therapy.

"These phase II results support our belief that Org 36286 will be able to reduce the number of injections for controlled ovarian stimulation considerably and make the treatment a much simpler procedure," stated Dr Mannaerts.

The phase III program of Org 36286's development - known as LIFE - has already been initiated and will be conducted in Europe, North America and Australia. The phase III program is designed to provide efficacy and safety data for subsequent new drug applications throughout the world. The first birth following treatment with a single injection of Org 36286 has already been reported during phase II testing (2).

About Organon

Organon - with shared head offices in Roseland, NJ, USA and Oss, The Netherlands - creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to remain or become one of the leading biopharmaceutical companies in each of its core therapeutic fields: fertility, gynecology, anesthesia and neuroscience. Research areas also include immunology and oncology. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.

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