QUEBEC CITY, Canada, May 17 /PRNewswire-FirstCall/ -- AEterna Laboratories Inc. (TSX: AEL; Nasdaq: AELA), along with its wholly-owned subsidiary Zentaris GmbH, today announced that it will present detailed positive Phase II data on cetrorelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, in endometriosis and benign prostatic hyperplasia (BPH) during the Investor and Analyst Day being held in New York City today. These results will form the basis for further development of cetrorelix through collaboration with Solvay Pharmaceuticals, the Company's worldwide (ex-Japan) exclusive development and marketing partner. In addition, AEterna/Zentaris will present new encouraging preclinical data on perifosine, the Company's novel, first-in-class, oral AKT inhibitor, in combination with radiation therapy, supporting the ongoing clinical development of perifosine in combination with radiotherapy as a potential treatment for multiple types of cancer. AEterna/Zentaris plans to initiate Phase II trials of perifosine in combination with radiotherapy, through the ongoing collaboration with the Netherlands Cancer Institute of Amsterdam, after presenting Phase I results at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2004.
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 and formulations of cetrorelix in patients with endometriosis. Highly encouraging results were seen in 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. Assessment of pain (including dysmenorrhea, dyspareunia, and chronic pelvic pain), one of the main endometriosis-related symptoms, up to 24 weeks after the first injection, demonstrated that cetrorelix use was associated with a highly statistically significant (p equals less than 0.001) improvement of pain score. Furthermore, therapeutic response associated with cetrorelix use was both rapid in onset (within four weeks) and durable, extending up to five months following cessation of cetrorelix administration. Importantly, clinical benefit seen with the use of cetrorelix was associated with only a slight and transient suppression of serum estrogen levels. Cetrorelix was well tolerated and was not associated with side effects, such as hormonal withdrawal symptoms seen during menopause.
The Company believes that Phase II data from this placebo-controlled trial, backed up by data from the two open-label, non-placebo controlled Phase II trials, 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.
Cetrorelix in BPH
Two placebo-controlled Phase II trials were conducted to evaluate the efficacy of cetrorelix, including durability of therapeutic response associated with cetrorelix use during a four-month post-injection follow-up period, in 250 patients with BPH.
In the first Phase II trial, patients with BPH received a single intramuscular injection of 30 mg or 60 mg of the same depot formulation of cetrorelix as that used in the placebo-controlled trial for endometriosis discussed above. In the second Phase II trial, patients received four weekly subcutaneous injections of 5 mg or 10 mg of a different formulation of cetrorelix. In both studies, the clinical effects were followed for four months after the last injection.
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. Importantly, the therapeutic response lasted three months following cessation of cetrorelix administration. In addition, the use of cetrorelix was associated with a slight reduction of prostate size. The clinical benefits seen with the use of cetrorelix were associated with a transient decrease of serum testosterone which never reached the castration level and thus 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 for this condition is expected to be around US$1.8 billion.
New preclinical data on perifosine in combination with radiotherapy
AEterna/Zentaris will also present new encouraging preclinical (in vivo) data on perifosine, the Company's novel, first-in-class, oral AKT inhibitor in combination with radiation therapy.
Mouse xenograft tumor models were used to evaluate the anti-tumor activity of oral administration of perifosine or radiation alone as compared to perifosine in combination with radiation. Whereas the use of either treatment modality alone only delayed tumor growth, the combination regimen with both treatments led to complete tumor regression.
The Company believes that these in vivo results support the ongoing clinical development of perifosine in combination with radiotherapy as a potential treatment for multiple types of cancer. Phase I data on perifosine in combination with radiation therapy will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2004.
AEterna/Zentaris plans to initiate Phase II trials of perifosine in combination with radiotherapy, through the ongoing collaboration with the Netherlands Cancer Institute of Amsterdam.
Advancement of teverelix in Phase IIa trials
Earlier today, Ardana Bioscience, the worldwide partner of AEterna/Zentaris for the development and marketing of teverelix, a LHRH antagonist, has separately announced the initiation of a Phase IIa trial for patients with prostate cancer, as well as the planned initiation of a new Phase IIa trial in patients with BPH to be started later this week. The advancement of teverelix into Phase IIa follows a recently completed Phase I trial which helped establish the dosage regimens necessary to achieve different levels of testosterone suppression.
An audio webcast of the Investor and Analyst Day presentations is available live and may be accessed by visiting the Investors section of AEterna's website, http://www.aeterna.com/ . A replay will also be available at the same site.
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 enlarged prostate (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-
AETERNA LABORATORIES INC.