Navigation Links
Clinical Update - Decapeptyl(R)/Trelstar(R) 6-Month Formulation in Advanced Prostate Cancer
Date:2/12/2008

- Presentation of Efficacy and Safety Phase III Results -

LAUSANNE, Switzerland, Feb. 12 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist focusing on serious medical conditions and particularly oncology, presented today at the 9th International Symposium on GnRH in Berlin, Germany, the results of a phase III study with its new 6-month formulation of Decapeptyl(R)/Trelstar(R) (triptorelin), a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of advanced prostate cancer. These results show similar efficacy and safety to the already marketed 1- and 3-month formulations.

This multicenter, open, non-comparative, phase III study on the efficacy and safety of two consecutive injections of triptorelin 6-month formulation in 120 patients with advanced prostate cancer, showed that 97.5% of patients achieved castrate levels of serum testosterone 28 days after the first injection and that 93% of the patients maintained serum testosterone levels below castrate level (defined as < or equal to 1.735 nmol/L or 50 ng/dL) from week 8 to 48. These efficacy results are similar to those obtained previously with repeated administrations of the 1- and 3-month formulations of triptorelin. Furthermore the adverse event profile of the new 6-month formulation of triptorelin is fully comparable to that observed with the 1- and 3-month formulations.

"Our 1- and 3-month formulations of Decapeptyl(R) and Trelstar(R) are used worldwide in the treatment of prostate cancer. However they require one injection every 4 or 12 weeks respectively. The 6-month formulation will improve patient compliance and increase convenience and comfort with the need of only one intramuscular injection every 24 weeks," said Kamel Besseghir, CEO of Debiopharm S.A.

About Decapeptyl(R)/Trelstar(R)

Triptorelin was licensed-in from Tulane University in 1982. Debiopharm developed and submitted a 1- and 3-month sustained release formulation of triptorelin embonate in Europe and the United States. The product is now marketed worldwide for the treatment of advanced prostate cancer, endometriosis, precocious puberty, in-vitro fertilisation programs, and uterine fibroids. Licensees include Ipsen, Watson, Ferring, Tecnofarma, Ache, Rowfarma and Sidus. Current licensee sales are of US $300M.

About Debiopharm Group

Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. Debiopharm develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing.

Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.

Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed three products with global combined sales in excess of $2.6 billion in 2006.

For more information on Debiopharm Group, please visit: http://www.debiopharm.com.

Debiopharm S.A. Contacts Additional Media Contacts

Herve Porchet In London

VP, Medical Affairs Maitland

Tel.: +41 (0)21 321 01 11 Brian Hudspith

Fax: +41 (0)21 321 01 69 Tel.: +44 (0)20 7379 5151

hporchet@debiopharm.com bhudspith@maitland.co.uk

In New York

Russo Partners, LLC

Wendy Lau

Tel.: +1 212-845-4272

Fax: +1 212-845-4260

wendy.lau@russopartnersllc.com


'/>"/>
SOURCE Debiopharm Group
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. AGI Dermatics Clinical Data Indicate Bicyclic Monoterpene Diols Suppress MMP1 and Stimulate Collagen Through TNF-a Signaling
2. Genetic Immunity Presents Clinical Data on DermaVir Patch Immune Therapy at 15th Annual Conference on Retroviruses and Opportunistic Infections
3. Pixantrone Shows Activity in a Preclinical Study of Experimental Autoimmune Myasthenia Gravis (EAMG)
4. Independent Clinical Results Confirm Up to a 7-Centimeter Reduction in Body Circumference Using UltraShape(TM) Non-Invasive Fat Reduction and Body Contouring System
5. Clinical Experience With Peregrines Anti-Cancer Agent Bavituximab Presented at Leading Symposium on Anti-Angiogenic Agents
6. Ardea Biosciences Presents Preclinical Data Demonstrating Favorable Resistance Profiles for Non-Nucleoside Reverse Transcriptase Inhibitors for the Treatment of Human Immunodeficiency Virus
7. IDX899 Demonstrates Rapid and Profound Inhibition of HIV Replication in a Phase I/II Clinical Trial in Treatment-Naive HIV-Infected Patients
8. Rapid Growth of Asia-Pacific Clinical Trials Market Focus of New CenterWatch Report
9. Northwestern Offers Clinical Research and Regulatory Administration Graduate Certificate Program
10. Multiple Dose Clinical Trial of TorreyPines Therapeutics Tezampanel Demonstrates Compound is Safe and Well-Tolerated
11. Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... 2017 IRIDEX Corporation (Nasdaq: IRIX ... for the fourth quarter and 2016 after the close ... management team will host a corresponding conference call beginning ... Investors interested in listening to the conference call ... callers or (703) 326-3030 for international callers, using conference ...
(Date:2/22/2017)... , Feb. 22, 2017 Summary ... infarction partnering deals and agreements entered into by ... full report: http://www.reportlinker.com/p03605670-summary/view-report.html Description The ... understanding and access to partnering deals and agreements ... - Trends in partnering deals ...
(Date:2/22/2017)... , Feb. 22, 2017 Merrimack Pharmaceuticals, Inc. ... will host its Fourth Quarter 2016 investor conference call and ... The call will cover an update on ... quarter and full year 2016 financial results. A press release ... be issued the morning of Wednesday, March 1. Investors and ...
Breaking Medicine Technology:
(Date:2/22/2017)... ... February 22, 2017 , ... ... in recent years. The technology is so cutting edge, in fact, the U.S. ... for stem cell procedures. However, successful patient outcomes in certain clinical stem cell ...
(Date:2/22/2017)... (PRWEB) , ... February 22, 2017 , ... ... its certification exam and eligibility requirements effective with the April 2017 testing period. ... 1995. , “The Care Manager Certified (CMC) exam is periodically re-calibrated to ...
(Date:2/22/2017)... Dallas, TX (PRWEB) , ... ... ... HCC Risk Adjustment solution leverages advanced data analytics to accurately understand each ... ensure proper reimbursement for a given population. This new solution helps transform ...
(Date:2/22/2017)... ... ... Doctors on Liens is continuing its steady expansion of medical specialties throughout ... North Valley Eye Medical Group in Mission Hills . Eye injuries and vision ... cases. These injuries have a major impact on the quality of life of ...
(Date:2/22/2017)... ... February 22, 2017 , ... Using the power of the ... simple online checklist. Over a period of just 24 months, thousands of individuals interested ... online checklist called T.A.D. , “The internet is not getting quieter. In fact it’s ...
Breaking Medicine News(10 mins):