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Positive Results Announced From Six Phase 2 Trials of Cetrorelix
Detailed Phase II data with new depot formulation of cetrorelix in endometriosis and in pre-surgical treatment of uterine myomas will be presented during the 18th World Congress of the International Federation of Fertility Societies (IFFS), which will be held in Montreal, Canada, on May 23-28, 2004.
“The striking results we have seen with cetrorelix in these trials, particularly in endometriosis, deliver on the promise of LHRH antagonists and are the culmination of many years of research and development efforts which originated from Dr. Schally’s Nobel-Prize winning research into LHRH and its antagonists,” said Prof. Jürgen Engel, Chairman & Managing Director of Zentaris GmbH, Executive Vice President R&D and Chief Operating Officer at Æterna. “Unlike other LHRH antagonists currently on the market or in clinical development, cetrorelix has a unique profile, avoiding total reduction (castration) of the different hormone levels. In addition, modulation of the epidermal growth factor receptor (EGFr) levels by cetrorelix has been shown in myoma cells, an effect that could be broadly applicable outside the cancer area.”
“We are very excited about these positive Phase II results and are preparing a development plan in the different indications to expedite the registration of cetrorelix. We are especially enthusiastic about endometriosis for which no good treatment is currently available,” stated Dr. Werner Cautreels, Solvay Pharmaceuticals’ Global Head of R&D.
According to Gilles Gagnon, President and Chief Executive Officer at Æterna, “cetrorelix, together with perifosine, form the cornerstone of our pipeline and, as such, we are very excited about the prospect of seeing cetrorelix enter pivotal trials in major markets. We look forward to further leveraging the depth and breadth of the product pipeline that we obtained through the acquisition of Zentaris to continue to deliver benefits to patients and value to our shareholders.”
The placebo-controlled study demonstrated that cetrorelix use was associated with a rapid and durable therapeutic response, namely improvement of endometriosis-related symptoms, such as pelvic pain, extending up to several months following only two intramuscular injections of cetrorelix with a one month interval.
The Company believes that the clinical data indicate that cetrorelix, unlike currently used treatments for endometriosis such as LHRH agonists, is suitable for long-term use as an intermittent treatment for endometriosis.
Endometriosis is the growth of the endometrium, or the inside lining of the uterus, outside of the uterus and is dependent upon the level of estrogen. Endometriosis affects approximately 10% to 20% of women of child-bearing age, and there is still a high medical need for new treatments. The total market size in 2003 was estimated to be around US$800 million.
Placebo-controlled trials have demonstrated that subcutaneous administrations of cetrorelix lead to the reduction of myoma/uterine volume within one month only.
Uterine myoma is a benign tumor of the uterus which is composed of muscle tissue. The growth of uterine myomas depends on the level of estrogen. Approximately 15% of all women of child-bearing age have uterine myomas. It is estimated that more than US$150 million are spent annually on drug treatment.
Benign Prostatic Hyperplasia (BPH)
Two placebo-controlled Phase II trials were conducted in BPH. As early as one month following initiation of therapy, data from both trials demonstrated a dose-dependent improvement of clinical symptoms, including IPSS (International Prostate Symptom Score) and maximum uroflow in the cetrorelix treatment group, in comparison with the placebo group, and the positive effect lasted three months without additional administration of cetrorelix. Furthermore, the use of cetrorelix was associated with a slight reduction of prostate size and did not have an adverse influence on sexual activity or libido.
Benign prostate hyperplasia is characterized by an abnormal, but not malignant, testosterone-mediated growth of prostate tissue. BPH is estimated to affect approximately 33 million men over 60 years of age. In 2004, the amount spent on drug treatment is expected to be around US$1.8 billion.
Source: Æterna Laboratories Inc.