IND accepted by FDA First study to be initiated before year-end QUEBEC CITY, Nov. 29 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) today announced the Company's plan to initiate its Phase 3 program in benign prostatic hyperplasia (BPH) before year-end with its luteinizing hormone-releasing hormone (LHRH) antagonist compound, cetrorelix, after the Company's Investigational New Drug Application (IND) was accepted by the U.S. Food and Drug Administration (FDA). The first study of this Phase 3 program titled, "Cetrorelix pamoate intermittent IM dosage regimens in patients with symptomatic BPH: a 1 year placebo-controlled efficacy study and long-term safety assessment", will assess an intermittent dosage regimen of cetrorelix as a potential safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms, under the supervision of lead investigator, Herbert Lepor, M.D., Professor at NY University School of Medicine, New York. This first study, involving approximately 600 patients, is part of an extensive Phase 3 program enrolling a total of about 1,500 patients, which will include other large safety and efficacy studies conducted in North America and Europe. "Cetrorelix has shown promising and compelling results in our prior extensive Phase 2 program, and we are now very excited about the possibility of bringing to market a safe and novel treatment for the millions of men suffering from BPH," said Dr. Jurgen Engel, Executive Vice President, Global R&D and Chief Operating Officer at AEterna Zentaris. "We believe cetrorelix has significant potential in this indication especially with its intermittent mode of administration of only two treatments by intra-muscular injection repeated after a six-month interval, contrary to daily oral intake for current treatments, thus alleviating the issue of patient compliance and convenience. Assuming conclusive results for this Phase 3 program, we would expect to file an NDA by mid-2009." Gilles Gagnon, AEterna Zentaris President and Chief Executive Officer added, "We are very excited to be initiating our Phase 3 program with our flagship product candidate, cetrorelix. We are also proud of our execution on a development front as this represents a critical strategic milestone in the evolution of our Company into a late-stage biopharmaceutical company. Considering the vast experience we have with this compound and the positive data we have seen thus far, we are confident in our abilities to bring this compound to an NDA filing and, given its known attributes, its potential to successfully penetrate a US$4 billion plus market such as BPH." About the Phase 3 Program with Cetrorelix in BPH In the first multi-center study, patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS). Patients will then be allocated to cetrorelix in a double-blind, randomized, double-dummy, placebo-controlled fashion. Patients will be administered an intra-muscular (IM) injection of cetrorelix at Week 0, 2, 26 and 28 and will be followed up to Week 52. Then, in an open-label fashion, patients will be administered an IM injection of cetrorelix at Week 52, 54, 78 and 80 and will be followed up to Week 90. The primary efficacy endpoint of this first study is absolute change in IPSS between baseline before beginning treatment and Week 52, while safety endpoints include changes in sexual function as well as BPH symptom progression equal to or more than 4 points and/or acute urinary retention and/or need for BPH related surgery. Other important endpoints consist of plasma levels of testosterone and changes in bone mineral density. This first study will be conducted across the United States and Canada and will involve approximately 600 patients under the supervision of lead investigator, Herbert Lepor, M.D., Professor at NY University School of Medicine, New York. Dr. Lepor was the lead investigator for a prior Phase 2 trial with cetrorelix in BPH. The second multi-center study of this Phase 3 program is expected to be initiated in the first half of 2007 and will enroll approximately 300 patients in Europe. Patients will receive cetrorelix according to similar administration regimens used in the first study. The third multi-center study of this Phase 3 program, which is expected to be initiated in the second half of 2007, will be an open-label, single-armed safety study involving approximately 600 patients in both North America and Europe. About Benign Prostatic Hyperplasia BPH is characterized by an abnormal benign growth of the prostatic tissues caused by testosterone. Symptoms linked to BPH include pain while urinating and frequent urges to urinate during the night and sometimes, kidney problems. In some cases, if left untreated, BPH may develop into prostate cancer. BPH affects more than 50% of men 60 years and over, with approximately 56 million cases in the U.S., Europe and Japan. In 2004, BPH treatment represented a market size of over US$4 billion. Contrary to most of the present treatments for BPH, cetrorelix is not associated with side-effects such as erectile dysfunction, loss of libido and chemical castration. According to Decision Resource, cetrorelix is currently the most advanced LHRH-antagonist in development for the treatment of BPH. About Cetrorelix Cetrorelix is part of AEterna Zentaris' LHRH antagonist therapeutic approach. This peptide-based active substance was developed by the Company in cooperation with Nobel Prize winner Professor Andrew Schally of the U.S. Veterans Administration in Miami. Cetrorelix is marketed under the brand name Cetrotide(R), the first LHRH antagonist approved for therapeutic use as part of in vitro fertilization programs (controlled ovulation stimulation/assisted reproductive technologies) in Europe, the USA and Japan. It was launched on the market through Serono S.A. in the USA, Europe and in several other countries, as well as in Japan through Shionogi. Cetrorelix is currently in a pivotal clinical program for endometriosis sponsored by the Company's partner, Solvay. In addition to the Phase 3 program in BPH, cetrorelix is in a Phase 2 program in this same indication in Japan, sponsored by the Company's partner, Shionogi. About the Cetrorelix Successful Phase 2 Program Cetrorelix has shown to adequately suppress the formation of the male sex hormone testosterone, which plays a principal role in cell growth of the prostate. Since cell growth is stopped, surgical removal of the prostate might be avoided. All studies performed so far with cetrorelix in patients with symptomatic BPH, revealed an improvement in symptoms as assessed primarily by the IPSS and an increase in urinary peak flow rate. Studies have also shown the excellent safety and tolerability profile of cetrorelix. Cetrorelix has successfully completed a broad 7-Phase 2 program in BPH, endometriosis, and uterine myoma. This extensive clinical program involved 735 patients and yielded statistically significant and medically important results. Rapid and durable responses were observed without chemical castration and cetrorelix proved to have an excellent safety and tolerability profile. Overall, cetrorelix has shown to have a fast onset of action allowing for a shorter treatment period, which could translate into an intermittent/chronic therapy. Such long treatment-free intervals are actually supported by the results derived from multiple Phase 2 placebo-controlled studies. About AEterna Zentaris Inc. AEterna Zentaris Inc. is a growing global biopharmaceutical company focused on endocrine therapy and oncology with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at http://www.aeternazentaris.com/. Forward-Looking Statements 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. DATASOURCE: AETERNA ZENTARIS INC. CONTACT: Media Relations: Paul Burroughs, (418) 573-8982, ; Investor Relations: Jenene Thomas, (418) 655-6420,

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