Navigation Links
AEterna Zentaris Completes Patient Recruitment for Second Efficacy Trial of its Phase 3 Program with Cetrorelix in Benign Prostatic Hyperplasia
Date:10/1/2008

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 http://www.aezsinc.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. 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.


'/>"/>
SOURCE AETERNA ZENTARIS INC.
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:
*Name:
*Comment:
*Email:
(Date:12/4/2016)... , Dec. 3, 2016  In five studies ... Hematology (ASH) Annual Meeting and Exposition in ... engineering methods to improve the delivery of life-saving treatments ... new methods are designed to carry therapies directly to ... most, which could provide a substantial advantage over traditional, ...
(Date:12/2/2016)... , Dec. 2, 2016 Amgen (NASDAQ: ... today announced the submission of a Marketing Authorization Application (MAA) ... biosimilar candidate to Avastin ® (bevacizumab). The companies believe ... the EMA. "The submission of ABP 215 ... to expand our oncology portfolio," said Sean E. Harper ...
(Date:12/2/2016)... ... ... Aerocom Healthcare ( http://www.aerocomhealthcare.com ), representing the global leader ... for tracking and securing medications at booth 676 at the ASHP Midyear Clinical ... a proven solution for tracking medications via its system from pharmacy to nursing ...
(Date:12/2/2016)... ... December 02, 2016 , ... The ... to collaboratively developing improved chemistry, manufacturing and control technologies for the pharmaceutical ... with robust, probe-based sampling. , Online liquid chromatography analysis is becoming ...
Breaking Biology Technology:
(Date:11/19/2016)... -- Securus Technologies, a leading provider of civil and ... and monitoring, announced today that it has offered a ... independent technology judge determine who has the largest and ... calling platform, and the best customer service. ... what we do – which clearly is not the ...
(Date:11/17/2016)... it has just released a new white paper authored by Zettar that covers the ... transfer storage solutions. Photo - http://photos.prnewswire.com/prnh/20161116/440463 ... ... ... Setting up a high performance computing or HPC system can be a complicated endeavor ...
(Date:11/15/2016)... 2016  Synthetic Biologics, Inc. (NYSE MKT: SYN), ... the gut microbiome, today announced the pricing of ... its common stock and warrants to purchase 50,000,000 ... to the public of $1.00 per share and ... the offering, excluding the proceeds, if any from ...
Breaking Biology News(10 mins):