Navigation Links
Aeterna Zentaris Begins Second Phase 3 Trial of Cetrorelix for Benign Prostatic Hyperplasia
Date:3/26/2008

omization commenced in April 2007, 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 will receive cetrorelix by IM injection at Week 52, 54, 78 and 80 will be followed up to Week 90.

The second multi-center Phase 3 efficacy study for which first patient dosing was announced today, will enroll approximately 400 patients in Europe. Patients in this randomized placebo-controlled study with open-label extension, will 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, expected to commence shortly, is an 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
'/>"/>

SOURCE AETERNA ZENTARIS INC.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Aeterna Zentaris Reports Fourth Quarter and Full-Year 2007 Financial and Operating Results
2. AEterna Zentaris and Paladin Labs Announce Sale and Purchase of Miltefosine Rights
3. AEterna Zentaris Announces the Departure of SVP, Administrative and Legal Affairs
4. Aeterna Zentaris to Announce Fourth Quarter and Full-Year 2007 Financial and Operating Results on March 5, 2008
5. AEterna Zentaris to Present at the Upcoming Roth Capital Partners 20th Annual OC Growth Stock Conference in Dana Point, California
6. AEterna Zentaris Reports First Patients Treated with Anti-Cancer Compound AEZS-108 in Phase 2 Trial in Ovarian and Endometrial Cancers
7. AEterna Zentaris to Further Develop Three Follow-up Multi-targeted Cytotoxic Candidates to AEZS-112 as Potential Novel Cancer Treatment
8. AEterna Zentaris Announces Outcome of Managements Strategic Review
9. AEterna Zentaris to Present at Upcoming UBS Global Life Sciences Conference in New York
10. AEterna Zentaris completes management team with the appointment of Chief Medical Officer
11. SPO Medical Begins Shipping PulseOx 6000(TM) and PulseOx 6100(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/18/2014)... UPTON, NYElectronic devices with unprecedented efficiency and ... materials that use built-in electric polarizations to ... magnets inside most popular data-driven technology. But ... stumbling blocks, including a curious habit of ... at the U.S. Department of Energy,s Brookhaven ...
(Date:8/18/2014)... According to a new ... Science Reagents Market(Products- PCR Reagent Kits, Cell and ... Reagents and Others; End Users- Commercial and Contract ... Forensic Laboratories)- Global Industry Analysis, Size, Share, Growth, ... life science reagents market was valued at USD ...
(Date:8/18/2014)... Aug. 18, 2014 TNI BioTech, Inc. (OTC-BB: ... the manufacturing and marketing of innovative therapies for autoimmune ... is providing a second notice of TNI BioTech,s annual ... the announcement, Noreen Griffin , founder and CEO ... for your participation in the Annual Meeting. On behalf ...
(Date:8/18/2014)... August 18, 2014 China is ... for the clinical research industry. Clinicaltrial.gov statistics highlight ... to its aging population; a high increase in ... a densely populated pool of patients and a ... these positive points, China also presents challenges for ...
Breaking Biology Technology:Promising ferroelectric materials suffer from unexpected electric polarizations 2Promising ferroelectric materials suffer from unexpected electric polarizations 3Promising ferroelectric materials suffer from unexpected electric polarizations 4Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 2Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 3Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 4Global Life Science Reagents Market Expected to Reach USD 25.7 Billion in 2019: Transparency Market Research 5TNI BioTech Inc., provides 2nd Notice of Annual Meeting September 4, 2014 2TNI BioTech Inc., provides 2nd Notice of Annual Meeting September 4, 2014 3TNI BioTech Inc., provides 2nd Notice of Annual Meeting September 4, 2014 4China – Land of Opportunities & Challenges for the Clinical Research Industry, New Webinar Hosted by Xtalks 2
... and NEW YORK, Sept. 17 ,Microbia, Inc. ... ), today announced,that they have entered into ... to,co-develop and co-market Microbia,s first-in-class compound linaclotide.,Linaclotide ... of,constipation-predominant irritable bowel syndrome (IBS-C), chronic,constipation (CC), ...
... Experience in Pulmonary and Infectious Disease ... ... a,clinical stage biopharmaceutical company focused on developing products to,overcome issues of ... Company,s Chief Medical Officer. Dr. Loutit,joins Mpex from InterMune, Inc. where ...
... Sept. 17 Kyphon Inc.,(Nasdaq: KYPH ... clearance from the,Federal Trade Commission (FTC) and ... Improvements Act of 1976 (as amended) with,respect ... assets,and associated intellectual property rights of Disc-O-Tech ...
Cached Biology Technology:Microbia and Forest Laboratories Announce Linaclotide Co-Development and Co-Marketing Collaboration 2Microbia and Forest Laboratories Announce Linaclotide Co-Development and Co-Marketing Collaboration 3Microbia and Forest Laboratories Announce Linaclotide Co-Development and Co-Marketing Collaboration 4Microbia and Forest Laboratories Announce Linaclotide Co-Development and Co-Marketing Collaboration 5Mpex Pharmaceuticals Names Dr. Jeffery Loutit as Chief Medical Officer 2Mpex Pharmaceuticals Names Dr. Jeffery Loutit as Chief Medical Officer 3Federal Trade Commission Clears Kyphon's Acquisition of Non-Vertebroplasty Spine-Related Assets of Disc-O-Tech 2
(Date:8/19/2014)... parts of the world, leprosy and tuberculosis live ... of leprosy per year, with nearly all of ... available century-old vaccine Bacille Calmette-Guerin, or BCG, provides ... so a more potent vaccine is needed to ... a stronger weapon against both diseases., In a ...
(Date:8/19/2014)... Aug. 19, 2014 ) -- Scientists at the Houston ... up and transfer single cells using a pipette -- ... describe this engineering feat and preliminary test results in ... American Chemical Society . , "Studying single cells and ... biomedical research," said nanomedicine department. faculty member Lidong Qin, ...
(Date:8/19/2014)... been awarded a nearly $40,000 grant from the National ... of the National Park Service (NPS) and U.S. Department ... study of the energy efficiency and cost effectiveness of ... climates. , Radiant barriers are reflective thermal insulations commonly ... thereby reducing the amount of heat emitted in the ...
Breaking Biology News(10 mins):New vaccine shows promise as stronger weapon against both tuberculosis and leprosy 2Moving single cells around -- accurately and cheaply 2UTSA researcher awarded $38K+ to evaluate energy efficiency options for historic homes 2UTSA researcher awarded $38K+ to evaluate energy efficiency options for historic homes 3
... Despite ongoing public health efforts, E. coli ... sickness and death throughout the world. But the ... published today in the scientific journal Nature , researchers ... discovered a molecule,s previously unknown role in fighting off ...
... of North Carolina scientists have uncovered a new strategy ... and chronic obstructive pulmonary disorder better clear the thick ... to life-threatening infections. In a new report appearing online ... researchers show that the "SPLUNC1" protein and its derivative ...
... July 13, 2012, Shenzhen, China - An international team, ... Academy of Science, and BGI, the world,s largest genomics ... salt cress ( Thellungiella salsuginea ), a wild salt-tolerant ... tool for exploring mechanisms of adaptive evolution and sheds ...
Cached Biology News:La Jolla institute identifies critical cell in fighting E. coli infection 2La Jolla institute identifies critical cell in fighting E. coli infection 3New proteins to clear the airways in cystic fibrosis and COPD 2Salt cress genome yields new clues to salt tolerance 2
Green Standard is fluorescein....
Red Standard is sodium salt of resorufin....
Human Jagged 2 Biotinylated Affinity Purified PAb...
RayBio L Series 507: RayBio Label-based Antibody Array I (2 membranes) Class: Antibody Array Products Product Group: Antibody Array...
Biology Products: