QUEBEC CITY, May 25 /PRNewswire-FirstCall/ -- AEterna Laboratories Inc. (TSX: AEL; Nasdaq: AELA), along with its wholly-owned subsidiary Zentaris GmbH, announced today that the Company will present further detailed positive Phase II data on cetrorelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, in endometriosis and pre-surgical treatment of uterine myomas at today's session of the World Congress of the International Federation of Fertility Societies (IFFS) being held in Montreal. These results combined with those previously announced, will form the basis for further development of cetrorelix by Solvay Pharmaceuticals, the Company's worldwide (ex-Japan) exclusive development and marketing partner for this product candidate. In addition, this will trigger an undisclosed milestone payment by Solvay.
Cetrorelix in Endometriosis
A total of three Phase II trials, of which one was double-blind and placebo-controlled, were conducted to evaluate different dosage regimens (weekly and monthly) and formulations (for intramuscular and subcutaneous administration) of cetrorelix in 150 patients with endometriosis.
Highly encouraging results, including highly statistically significant (p(equal sign) less than 0.001) improvement of pain score, from the double- blind, placebo-controlled trial in two groups of 25 patients with endometriosis who received either placebo or depot formulation of cetrorelix by two intramuscular injections with a one-month interval were presented at the Company's Investor and Analyst Day held in New York City on May 17, 2004.
New data from an open-label Phase II trial evaluating three dosage regimens of weekly subcutaneous injections of cetrorelix in patients with endometriosis will be presented today at the IFFS meeting. Data from this trial demonstrated that the therapeutic response, namely a significant decrease in endometriosis-related symptoms, associated with the use of all three dosage regimens of cetrorelix was both rapid in onset (within four weeks after initiation of therapy) as well as durable, extending for at least two months following cessation of cetrorelix administration. Measurements of serum estrogen demonstrated that all dosage regimens of cetrorelix led to the suppression of the cycle-dependent hormone fluctuations, without leading to the pattern of hormonal withdrawal symptoms seen during menopause. Details on clinical responses according to dosage regimens will be presented during the Congress of the IFFS.
The Company believes that highly statistically significant Phase II data from this open-label trial, backed up by data from two other Phase II trials of which one was double-blind and placebo-controlled, support the long-term use of cetrorelix as an intermittent treatment for endometriosis, unlike currently used treatments for endometriosis such as LHRH agonists which are only suitable for short-term use.
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.
Cetrorelix in pre-surgical treatment of Uterine Myomas
Positive results from a double-blind, placebo-controlled, multi-center Phase II trial evaluating the subcutaneous formulation of cetrorelix, administered weekly for four weeks, as a pre-surgical treatment in 109 women with uterine myomas will also be presented today at the IFFS. Headline results from this trial were announced on April 29, 2004. In addition to evaluating the safety and tolerability of different doses of the new formulation, the trial also evaluated whether cetrorelix use could lead to the reduction of myoma and uterine volumes within a shorter treatment period than that normally required for LHRH agonists. Data from this trial demonstrated that cetrorelix use led to a reduction of myoma and uterine volumes after a one-month treatment period, which is significantly shorter than the 2-6 month treatment period typically required for LHRH agonists. The best response rate was obtained at a dose of 10 mg cetrorelix per week. Cetrorelix use did not lead to chemical castration.
Uterine myoma is a benign tumor of the uterus 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 annually more than US$150 million are spent on drug treatment.
About AEterna Laboratories
AEterna Laboratories Inc., along with its wholly-owned subsidiary Zentaris GmbH, is a biopharmaceutical company focused in oncology and endocrine therapy. Its extensive portfolio, from drug discovery to marketed products, includes perifosine, an orally-active AKT inhibitor in several Phase II trials for multiple cancers, and cetrorelix, an LHRH antagonist already marketed for in vitro fertilization under the brand name Cetrotide(R), and also in advanced clinical development for the treatment of uterine myoma, endometriosis and benign prostatic hyperplasia (BPH).
AEterna also owns 62% of its subsidiary Atrium Biotechnologies Inc. which develops and markets active ingredients and speciality fine chemicals in the health and personal care industry for the cosmetics, chemical, pharmaceutical and nutritional industries.
AEterna shares are listed on the Toronto Stock Exchange (AEL) and the NASDAQ National Market (AELA). News releases and additional information about AEterna are available on its website at http://www.aeterna.com/.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements.
AETERNA LABORATORIES INC.