Navigation Links
AEterna Zentaris Completes Patient Recruitment for Second Efficacy Trial of its Phase 3 Program with Cetrorelix in Benign Prostatic Hyperplasia

QUEBEC CITY, Oct. 1, /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and oncology, today reported the completion of patient recruitment for the Company's second efficacy trial of its Phase 3 program in benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate, with its flagship product candidate, cetrorelix, a Luteinizing Hormone Releasing Hormone (LHRH) antagonist. This second efficacy study involves approximately 400 patients, mainly in Europe.

"We are very pleased to have completed patient recruitment for this second efficacy trial as scheduled. Our Phase 3 program is progressing well and remains on track with first results expected for the third quarter of 2009," said Paul Blake MD, Senior Vice President and Chief Medical Officer of AEterna Zentaris. "We firmly believe that cetrorelix's novel therapeutic approach could lead to a more efficacious and convenient treatment for the millions of men with BPH."

The study, titled, "Cetrorelix pamoate in patients with symptomatic BPH: a double-blind, placebo-controlled efficacy study", involves approximately 400 patients, and will assess an intermittent dosage regimen of cetrorelix as a potential safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms. This Phase 3 trial, conducted in Europe under the supervision of lead investigator, Prof. Dr. Frans M.J. Debruyne, MD, of the Andros Mannenkliniek, Arnhem, The Netherlands, is part of the Company's Phase 3 program with cetrorelix being studied in approximately 1,500 patients in North America and Europe in men with symptomatic BPH.

About the Phase 3 Program with Cetrorelix in BPH

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 approximately 600 patients under the supervision of lead investigator, Herbert Lepor, MD, Professor at NY University 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 completion was announced today, involves approximately 400 patients, mainly in Europe. Patients in this randomized placebo-controlled study with open-label extension, 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 started in May 2008, is an ongoing open-label, single-armed study involving approximately 500 patients in both North America and Europe.

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 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.

In addition to the Phase 3 program in BPH, cetrorelix is also being studied in a Phase 2b program in this same indication in Japan, sponsored by the Company's partner, Shionogi.

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

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. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are requested by a governmental authority or applicable law.

Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. AEterna Zentaris to Present at BioContact Quebec on October 2, 2008
2. AEterna Zentaris to Present at Upcoming CIBC World Markets 7th Annual Eastern Investor Conference
3. AEterna Zentaris Reports Second Quarter 2008 Financial and Operating Results
4. AEterna Zentaris Announces Appointment of Prof. Jurgen Engel, Ph.D. as New President and CEO
5. AEterna Zentaris to Announce Second Quarter 2008 Financial and Operating Results on August 12, 2008
6. AEterna Zentaris Sells Quebec City Building for $7.1 million
7. AEterna Zentaris to Present at Upcoming Rodman & Renshaw Global Healthcare Conference and AUA Annual Meeting
8. AEterna Zentaris: Article on Phase 2 Trial with Cetrorelix in BPH to be Published in European Urology Journal
9. AEterna Zentaris Reports First Quarter 2008 Financial and Operating Results
10. AEterna Zentaris to Announce First Quarter 2008 Financial and Operating Results and Hold Annual Shareholder Meeting on May 7, 2008
11. AEterna Zentaris: Lead Investigator for Cetrorelix Trials in BPH Wins Best Poster Presentation Award at European Association of Urology Meeting in Milan
Post Your Comments:
(Date:12/1/2015)... , Dec. 1, 2015 Researchers at the ... Institute for Brain Research at MIT have engineered changes ... cut down on "off-target" editing errors. The refined technique ... use of genome editing. Science , ... three of the approximately 1,400 amino acids that make ...
(Date:12/1/2015)... VIEW, Calif. , Dec. 1, 2015 /PRNewswire/ ... the Transformational Health program. This program addresses ways ... period of change. ... Logo - ... every aspect of healthcare, as well as the ...
(Date:12/1/2015)... ROSEVILLE, Minn. , Dec. 1, 2015  The ... the recipient of the 2015 Tekne Award in the ... th at the Minneapolis ... who have played a significant role in developing new ... people living around the world. Clostridium difficile ...
(Date:12/1/2015)... , Dec. 1, 2015  CardioCell LLC, a ... stem cells for cardiovascular indications, intends to proceed ... based on recommendations from a Heart Failure Advisory ... Scientific Advisory Board members . In a ... Phase IIa safety and efficacy data from CardioCell,s ...
Breaking Biology Technology:
(Date:11/26/2015)... -- Research and Markets ( ) has announced ... Technology and Patent Infringement Risk Analysis" report to ... --> Fingerprint sensors using capacitive technology represent a ... vendor Idex forecasts an increase of 360% of the ... of the fingerprint sensor market between 2014 and 2017 ...
(Date:11/19/2015)... Nov. 19, 2015  Based on its in-depth analysis ... recognizes BIO-key with the 2015 Global Frost & Sullivan ... & Sullivan presents this award to the company that ... the needs of the market it serves. The award ... and expands on customer base demands, the overall impact ...
(Date:11/18/2015)... , Nov. 18, 2015  As new scientific discoveries ... doctors and other healthcare providers face challenges in better ... and patients. In addition, as more children continue to ... patient,s adulthood and old age. John M. ... Children,s Hospital of Philadelphia (CHOP) . --> ...
Breaking Biology News(10 mins):