QUEBEC CITY, June 10 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. , a global biopharmaceutical company focused on endocrine therapy and oncology, today announced the opening of an extended study in the Phase 3 program with cetrorelix pamoate for the treatment of benign prostatic hyperplasia (BPH), a benign enlargement of the prostate, affecting more than 20 million men in the U.S. alone. Sanofi-aventis U.S. LLC entered into a previously announced agreement with AEterna Zentaris for the development, registration and marketing of cetrorelix in BPH for the U.S. market.
As a result of this collaboration between sanofi-aventis U.S. and AEterna Zentaris, patients completing two years of therapy in the North American trial of cetrorelix, NCT00449150, will be eligible to continue with cetrorelix treatment, according to treatment regimen of the ongoing Phase 3 study, until the end of 2011. Patients entering this extension study will be followed-up for safety, International Prostate Symptom Score (IPSS) and quality of life during the extended treatment, providing follow-up data on cetrorelix for up to 5 years.
Juergen Engel, Ph.D., President and CEO of AEterna Zentaris commented, “We have been pleased with the decision of patients and their physicians to continue into this extended period of open-label treatment follow-up, sponsored by our partner sanofi-aventis U.S. We are confident that patients and their physicians will continue into this extension, as the continuation rate of patients into the open-label part of the study remains at over 90% of those eligible to continue at week 52 and compares favorably with those reported by others.(1) We look forward to presenting the data from the double-blind portion of the study in the next quarter.”
About the Phase 3 Program with Cetrorelix in BPH
Cetrorelix pamoate is currently in three Phase 3 trials involving more than 1,600 patients with symptomatic BPH in Canada, the United States and Europe.
The first multi-center efficacy study for which patient recruitment was completed in April 2008, is currently being conducted primarily in the United States and Canada, with additional sites in Europe and involves 667 patients under the supervision of lead investigator, Herbert Lepor, MD, Professor at NYU School of Medicine, New York. 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 are then randomly allocated to cetrorelix or placebo in a double-blind fashion. Patients are administered cetrorelix by intra-muscular (IM) injection at Week 0, 2, 26 and 28 and are followed up to Week 52. Then, in an open-label extension, patients receive cetrorelix by IM injection at Week 52, 54, 78 and 80 and are followed up to Week 90.
The second multi-center Phase 3 efficacy study for which patient recruitment was completed in October 2008, involves 420 patients, mainly in Europe. Patients in this randomized placebo-controlled study with open-label extension conducted under the supervision of lead investigator, Prof. Frans M.J. Debruyne, MD, of the Andros Mannenkliniek, Arnhem, The Netherlands, receive cetrorelix according to similar dosing regimens used in the first study.
The primary endpoint for both North American and European efficacy studies is absolute change in IPSS between baseline and Week 52. Other efficacy endpoints include additional measures of BPH symptom progression and the need for BPH-related surgery. Safety endpoints include changes in sexual function. Other important endpoints include plasma changes in levels of testosterone, and assessment of other adverse events.
The third study in the Phase 3 program, a multi-center safety study, for which patient recruitment was completed in December 2008, is an ongoing open-label, single-armed study involving 528 patients in North America. The lead investigator is Joel Kaufman, M.D., Associate Clinical Professor in Urology at University of Colorado School of Medicine in Denver, Colorado and at Urology Research Options in Aurora, Colorado.
First efficacy results are expected during the third quarter of 2009 with an NDA filing targeted in 2010.
About Cetrorelix
Cetrorelix pamoate is an investigational agent that has shown in Phase 2 studies to provide fast and long lasting relief of BPH symptoms and was well tolerated, with a low incidence of sexual side effects. Cetrorelix is part of AEterna Zentaris’ luteinizing hormone-releasing hormone (LHRH) antagonist therapeutic approach. This peptide-based active substance was developed by the Company in cooperation with Nobel Prize winner Prof. Andrew Schally, currently of the U.S. Veterans Administration in Miami.
Cetrorelix acetate 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 (now Merck Serono) in the U.S., Europe and in several other countries, as well as in Japan through Shionogi.
About Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is one of the most common diseases of aging men - affecting more than 20 million men in the United States - but its etiology is far from being completely understood. Data from ongoing research suggest BPH and lower urinary tract symptoms (LUTS) are more complex conditions than once thought. While previous research on BPH etiology tended to focus on testosterone and other hormones, more recent research suggests other factors - including inflammation, various growth factors, and adrenoreceptors - actually may play a greater role in the development of BPH and LUTS.
BPH is associated with LUTS, including: frequent urination, a sudden, uncontrollable urge to urinate, waking at night to urinate (nocturia), difficulty starting a urine stream (hesitancy and straining), decreased strength of the urine stream (weak flow), feeling that the bladder is not completely empty, an urge to urinate again soon after urinating and pain during urination (dysuria). Currently available therapies may improve symptoms to some degree, but often come with sexual and other side effects.
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a 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.aezsinc.com.
Forward-Looking Statements
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