Navigation Links
AEterna Zentaris Announces Results from Two Phase 3 Studies with Cetrorelix in Benign Prostatic Hyperplasia
Date:8/17/2009

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 Phase 3 efficacy trial Z-033, titled, "Cetrorelix pamoate intermittent IM dosage regimens in patients with symptomatic BPH: a 1-year placebo-controlled efficacy study and long-term safety assessment", involved 667 patients mostly in North America and assessed an intermittent dosage regimen of cetrorelix as treatment for BPH-related signs and symptoms.

As announced recently, patients completing the 52 week double-blind study are then allowed to continue into an open-label extension of this study, sponsored by sanofi-aventis, where patients receive the same dosing regimen of cetrorelix by IM injection at Week 52, 54, 78 and 80, and are followed up to Week 90. Patients entering this extension study will be followed-up for safety, IPSS and quality of life, thus providing follow-up data on cetrorelix for up to 5 years.

The second multi-center Phase 3 efficacy study Z-036 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, M.D., of the Andros Mannenkliniek, Arnhem, The Netherlands, receive cetrorelix according to similar dosing regimens used in the first efficacy study Z-033.

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 trial of the program is the safety study Z-041 titled, "Cet
'/>"/>

SOURCE AETERNA ZENTARIS INC.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results
2. AEterna Zentaris to Present at Upcoming Canaccord Adams 29th Annual Global Growth Conference
3. AEterna Zentaris to Announce Second Quarter 2009 Financial and Operating Results on August 11, 2009
4. AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma
5. AEterna Zentaris: New Data Published on its Ghrelin Antagonist Compound, AEZS-123 (JMV2959), Supports its Use in Alcohol Addiction
6. AEterna Zentaris Receives US$10 Million from Institutional Investors
7. AEterna Zentaris to Report Data from Safety Study of Phase 3 Program in Benign Prostatic Hyperplasia with Cetrorelix Ahead of Schedule
8. AEterna Zentaris Opens Extended Study for Cetrorelix in Benign Prostatic Hyperplasia
9. AEterna Zentaris Discloses Preliminary Phase 2 Trial Results for Perifosine in Combination with Radiotherapy for Non-Small Cell Lung Cancer
10. AEterna Zentaris Acquires All Assets from Ardana for Growth Hormone Secretagogue Compound, AEZS-130
11. AEterna Zentaris Presents Data Supporting Evaluation of AEZS-108 in Prostate Cancer at ASCO Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)... The ability to see through organs and even the ... well as fine-grained cellular structures has been a long-time ... Press July 31st in the journal Cell ... simple methods for making opaque organs, bodies, and human ... connections intact. The protocols could pave the way for ...
(Date:7/31/2014)... Colo. , July 31, 2014 ... awardee today with $25,000 to fund a translational ... inception in 2011, the gift was presented at ... Annual Meeting in Colorado Springs, ... specialize in neurointerventional approaches to neurovascular conditions, SNIS ...
(Date:7/31/2014)... 2014 Graphite Metallizing Corporation announces ... carts. These bearings are uniquely suited to prevent loss ... because of the high temperatures . , Recently, ... the design engineers at Graphite Metallizing to overcome problems ... their manufacturing operation, pans containing blocks of powder mixture ...
(Date:7/31/2014)... 2014 Research and Markets has ... 2014-2018" report to their offering. ... study of the genetic material or genomes of an ... for the discovery and development of diagnostic and therapeutic ... conditions. Genomics is supported by three major product segments: ...
Breaking Biology Technology:See-through organs and bodies will accelerate biomedical discoveries 2SNIS Foundation Bestows First Grant Award For Cutting-Edge NeuroInterventional Research 2SNIS Foundation Bestows First Grant Award For Cutting-Edge NeuroInterventional Research 3Graphite Metallizing Announces Bearings for High Temperature Oven Applications 2Graphite Metallizing Announces Bearings for High Temperature Oven Applications 3Global Genomics Market 2014-2018: Key Vendors are F. Hoffmann-La Roche, Life Technologies, Qiagen and Illumina 2
... of Magainins, the first of a new class of anti-infectives, ... advise Company on pexiganan ... Bulletin Board: MACM) today announced that following its,acquisition of rights ... Board. Dr. Zasloff discovered magainins in,the skin of the African ...
... 24, at 1:30 p.m. EDT, ALAMEDA, Calif., ... a biopharmaceutical company developing innovative therapies,for the treatment ... to discuss third quarter results on Wednesday, October ... Kenneth Chahine, Chief Executive,Officer, and Michael Coffee, Chief ...
... Kyphon Inc.,(Nasdaq: KYPH ) announced today that its ... Inc. (NYSE: MDT ) at a special,meeting of ... 26, 2007, Kyphon entered into a,definitive merger agreement with ... the outstanding shares of Kyphon common stock for,$71.00 per ...
Cached Biology Technology:MacroChem Announces Michael Zasloff, M.D., Ph.D. Joins Company's Scientific Advisory Board 2MacroChem Announces Michael Zasloff, M.D., Ph.D. Joins Company's Scientific Advisory Board 3MacroChem Announces Michael Zasloff, M.D., Ph.D. Joins Company's Scientific Advisory Board 4MacroChem Announces Michael Zasloff, M.D., Ph.D. Joins Company's Scientific Advisory Board 5Avigen, Inc. Announces Third Quarter 2007 Earnings Conference Call 2Kyphon Stockholders Approve Merger with Medtronic 2
(Date:7/31/2014)... United States, natural-gas production from shale rock has ... Yet scientists still do not fully understand the ... a report in the journal Frontiers in ... extraction continues to vastly outpace scientific examination, a ... and institutions, including Princeton University, concluded that determining ...
(Date:7/31/2014)... nearly 3,000 genes to the earliest common ancestor ... have created an extensive "Tree of Lepidoptera" in ... sequencing. , Among the study,s more surprising ... moths than to large ones, which completely changes ... also found that some insects once classified as ...
(Date:7/31/2014)... NCT00518336) shows the sustained efficacy, immunogenicity and ... vaccine Cervarix. Women vaccinated with the HPV-16/18 ... nine years, and vaccine efficacy (VE) against ... longest follow-up report for a licensed HPV ... full paper. , HPV and vaccination ...
Breaking Biology News(10 mins):'Fracking' in the dark: Biological fallout of shale-gas production still largely unknown 2'Fracking' in the dark: Biological fallout of shale-gas production still largely unknown 3UF study advances 'DNA revolution,' tells butterflies' evolutionary history 2UF study advances 'DNA revolution,' tells butterflies' evolutionary history 3Sustained efficacy, immunogenicity, and safety for GlaxoSmithKline's HPV vaccine 2Sustained efficacy, immunogenicity, and safety for GlaxoSmithKline's HPV vaccine 3
... ANN ARBOR, Mich.---University of Michigan School of Dentistry has ... may be the largest clinical study to date using genetic ... William Giannobile, professor at U-M dentistry and director of the ... Dentistry, will lead the study for U-M. "It,s ...
... and Building Media Inc. (BMI), a DuPont subsidiary, will ... help dramatically improve the energy efficiency of American homes ... 15 teams, appointed by the U.S. Department of Energy ... million for the initial 18 months to deliver innovative ...
... July 27, 2010 Innovotech Inc. (TSX-V: IOT), a pioneer ... exclusive distribution agreement with LevPharm Ltd of Israel to market ... within Israel. "We are very excited to enter into ... bioFILM PA test can have on improving patient care while ...
Cached Biology News:Landmark dental school study uses genetic test to help predict gum disease 2NJIT to help lead public/private partnership to develop high-efficiency homes 2
KAI 1 (G-2)...
Anti-Mouse Valpha 2 TCR, Purified (Clone B20.1) (rat IgG2a)...
Anti-OSMR Monoclonal Antibody Research Focus: cytokine/growth factor Storage: 4C Shipping Temperature: 4C...
... are designed for use with the ProQuest ... MaV203 contains deletions in the endogenous GAL4 ... two-hybrid systems. The strain also has leu2 ... bait and prey vectors. MaV203 contains three ...
Biology Products: