Healthcare Industry News: endometriosis
News Release - January 8, 2007
AEterna Zentaris Initiates First Study of Phase 3 Program with Cetrorelix in BPH - 600 Patient Trial Conducted in the United States and CanadaQUEBEC CITY, Jan. 8 (HSMN NewsFeed) - AEterna Zentaris Inc. (TSX: AEZ ; Nasdaq: AEZS ) today announced that the Company initiated the first of three studies in its Phase 3 program in benign prostatic hyperplasia (BPH) with its luteinizing hormone-releasing hormone (LHRH) antagonist compound, cetrorelix. The first study of the previously announced 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. The primary efficacy endpoint of this first study is absolute change in International Prostate Symptom Score (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.
"We are very excited to have initiated the first study of our Phase 3 program with our flagship product candidate, cetrorelix, and look forward to first patient dosing over the next month. We are yet another step closer to bringing cetrorelix to market and not only have the potential to conveniently, safely and effectively treat men who suffer from BPH, but also create tremendous value to our shareholders," stated Gilles Gagnon, President and Chief Executive Officer at AEterna Zentaris.
About the Phase 3 Program with Cetrorelix in BPH
In the first multi-center study, patients 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 is conducted across the United States and Canada and involves 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.
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®, 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 Merck KGaA 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 AEterna Zentaris Inc.
AEterna Zentaris Inc. is a late-stage pure-play 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 www.aeternazentaris.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.
Source: AETERNA ZENTARIS
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