Two Phase III Clinical Trials On Corifollitropin Alfa (Org 36286) Reach Randomization

Main Category: Fertility
Also Included In: Clinical Trials / Drug Trials
Article Date: 30 Jun 2007 - 1:00 PDT

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Organon, the human healthcare business unit of Akzo Nobel, announced recently that two out of three Phase III clinical trials with corifollitropin alfa (Org 36286), a new long-acting fertility hormone, have reached their randomization target.

Corifollitropin alfa is a new recombinant fertility hormone. It is the first of a new class of gonadotropins (a sustained follicular stimulant or SFS) of which, due to its long half-life, one single injection may replace the first 7 injections with conventional gonadotropins during a fertility treatment cycle.

The objective of the ENGAGE trial, the largest double-blind fertility trial ever performed, is to demonstrate clinical efficacy and safety of corifollitropin alfa 150 μg in a double-blind comparison with Organon's Puregon, one of the most commonly used preparations to treat infertile patients. The recruitment goal of the ENGAGE trial was to include a total of 1400 patients from 34 fertility clinics in Europe, USA and Canada and was started in July, 2006. The study reached its randomization target on June 10, 2007.

A second trial, the ENSURE trial, is an efficacy and safety trial with corifollitropin alfa 100 μg designed specifically for women who weigh less than 60 kg (133 lbs). This double-blind study comparing corifollitropin alfa with Puregon was started in January 2007 in 19 clinical trial centers in Europe and Asia with a recruitment goal of 330 patients by June 30, 2007. All 330 subjects have now been randomized.

David Nicholson, executive vice-president Research and Development at Organon commented: "The enthusiasm and dedication of investigators and staff involved in these trials was decisive in reaching our recruitment targets."

A third Phase III trial in the LIFE program (the TRUST trial) focuses on safety of repeated treatments with corifollitropin alfa, and is expected to complete recruitment on target by mid-August 2007.

- Corifollitropin alfa is a new biological entity (NBE) and is being developed for controlled ovarian stimulation to induce the development of multiple follicles in patients participating in an assisted reproductive technology program.

- Corifollitropin alfa is the first compound in a new class of long-acting fertility hormones called 'Sustained Follicle Stimulants' (SFS). The primary advantage of an SFS over current gonadotropins is the longer duration of action which allows a treatment regimen replacing 7 daily injections of current gonadotropins with one injection of corifollitropin alfa.

- The LIFE program is Organon's clinical development program for corifollitropin alfa for the therapeutic indication of controlled ovarian stimulation. The most important trials in this program are studies with the names ENGAGE (phase III efficacy and safety study with corifollitropin alfa 150 mcg), ENSURE (phase III efficacy and safety study in women ≤60 kg with corifollitropin alfa 100 mcg) and TRUST (phase III safety study on repeated treatment).

About Organon

Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.

http://www.organon.com

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