Corporate Banner
Satellite Banner
Genomics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

First Patient Treated in Phase III Study with SC Administration of Debio 8206

Published: Thursday, December 27, 2012
Last Updated: Thursday, December 27, 2012
Bookmark and Share
Administration of Debio 8206 by SC route will prove very convenient in prostate cancer patients.

Debiopharm Group™ (Debiopharm) has announced the treatment of its first patient in a multicentre, open, non-comparative Phase III study to investigate the efficacy, safety, and pharmacokinetics of two subcutaneous (SC) injections of Debio 8206 (triptorelin pamoate 22.5 mg 6-month formulation) in patients with advanced prostate cancer.

The study will be conducted in the Republic of South Africa and will involve 120 patients suffering mainly from advanced prostate cancer.

Patients with recurrent lower stage prostate cancer and rising prostate specific antigen (PSA) following local therapy failure who are candidates for androgen deprivation therapy will also take part.

The 6-month formulation is currently commercialized for an administration by the intramuscular (IM) route in several countries.

“We believe that the SC route of administration of Debio 8206 will prove very convenient, in prostate cancer patients also suffering from concomitant diseases requiring anticoagulation treatments. In these patients SC administration is often preferred due to a potential risk of haematomas at the injection site after intramuscular injection,” said Rolland-Yves Mauvernay, President and founder of Debiopharm.

Patient evaluation will be primarily based on the efficacy in achieving castrate levels of testosterone (< 1.735 nmol/L [50 ng/dL]) 28 days after the first injection of Debio 8206 and in maintaining castrate levels of testosterone from Day 57 to Day 337. The safety profile will also be evaluated.

Additional efficacy measures will include the assessment of the percentage of patients who show an increase in testosterone levels 48 hours after the second injection of Debio 8206, as well as the absence of gonadotropin (LH) stimulation 2 hours after the second injection of Debio 8206 and the change in PSA from baseline to study end.

In addition, Debio 8206 pharmacokinetics and testosterone pharmacodynamics will be assessed in a subset of 15 patients.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

FDA Grants Orphan Drug Designation to Debio 1143
Company grants FDA designation to Debio 1143 for the treatment of ovarian cancer.
Thursday, June 02, 2016
Debiopharm and EORTC Announce a Collaboration
Collaboration to investigate triptorelin for treatment of salivary gland cancers.
Thursday, January 14, 2016
EMA Grants Orphan Drug Designation to Debio 1143
Company grants EMA Designation to Debio 1143 for treatment of Ovarian Cancer.
Thursday, December 10, 2015
United and Debiopharm Announce the Launch of Pamorelin®
Pamorelin® one-, three- and six-month dosing option now available to patients in the Philippines.
Tuesday, December 08, 2015
Debiopharm’s Partner Yakult Announces Elplat® Approbation in Gastric Cancer
Approval for a supplemental new drug application for Elplat® in postoperative adjuvant chemotherapy in Japan.
Saturday, November 28, 2015
JCA and Debiopharm Group Announce Winners of the 2015 JCA-Mauvernay Award
The ‘JCA-Mauvernay Award 2015’ is awarded to Doctors Yutaka Kondo and Junko Takita.
Saturday, October 10, 2015
Debiopharm Announces Results of 2 Key Oncology Programs at AACR Conference
Company presents preclinical results for 2 anti-cancer targeted therapies Debio 1143 and Debio 1347.
Tuesday, April 21, 2015
Trelstar® Six-Month Dosing for Prostate Cancer Patients Launches in Canada
Trelstar® one-, three-, and six-month dosing options now available.
Wednesday, October 08, 2014
Orient EuroPharma and Debiopharm Group™ Announce Their Partnership
Both Companies also announces the launch of Pamorelin® LA in Singapore.
Tuesday, May 27, 2014
Curis and Debiopharm Report Preclinical Data for Debio 0932
Debio 0932 demonstrated anti-tumor activity and synergy with various SOC agents in in vitro and xenograft models of NSCLC and RCC.
Wednesday, April 09, 2014
Experimental Therapeutics Centre and Debiopharm Group™ to Collaborate
Collaboration for the development of an epigenetic innovative oncology target.
Tuesday, October 08, 2013
Diagnoplex S.A. Closes a Financing Round Led by Debiopharm Group™
Diagnoplex secures 1.3 million Swiss francs from financing round.
Friday, June 07, 2013
Debiopharm Group to Support Ascepion in the Development of Debio 1144
Development of Debio 1144 for the treatment of Chinese cancer patients.
Thursday, April 18, 2013
Chugai and Debiopharm Announce an Exclusive License Agreement for FF284
Chugai will grant Debiopharm an exclusive license to develop and commercialize FF284 in all countries.
Tuesday, January 08, 2013
Debiopharm, Immunexpress and Biocartis Announce Collaboration
Collaboration to advance development of SeptiCyte® Triage for managing sepsis.
Wednesday, December 26, 2012
Scientific News
Faecal Bacteria Linked to Body Fat
Researchers at King’s College London have found a new link between the diversity of bacteria in human poo – known as the human faecal microbiome - and levels of abdominal body fat.
Scientists Find Lethal Vulnerability in Treatment-Resistant Lung Cancer
The study describes how the drug Selinexor killed lung cancer cells and shrank tumors in mice when used against cancers driven by the aggressive and difficult-to-treat KRAS cancer gene.
How Baby’s Genes Influence Birth Weight And Later Life Disease
The large-scale study could help to target new ways of preventing and treating these diseases.
Genes Underlying Dogs’ Social Ability Revealed
The social ability of dogs is affected by genes that also seem to influence human behaviour, according to a new study from Linköping University in Sweden.
‘Cellbots’ Chase Down Cancer, Deliver Drugs Directly to Tumors
Programmable T cells shown to be versatile, precise, and powerful in lab studies.
Modified Yeast Shows Plant Response to Key Hormone
Researchers have developed a toolkit based on modified yeast to determine plant responses to auxin.
ReadCoor Launched to Commercialize 3D Sequencing Tech
ReadCoor will leverage the Wyss Institute’s method for simultaneously sequencing and mapping RNAs within cells and tissues to advance development of diagnostics.
NCI Collaborates with Multiple Myeloma Research Foundation
NCI collaborates with MMRF to incorporate genomic and clinical data into NCI Genomic Data Commons database.
Epigenetic Clock Predicts Life Expectancy
New research finds 5 percent of population ages faster, faces shorter lifespan.
Regulatory RNA Essential to DNA Damage Response
Researchers discover a tumour suppressor is stabilized by an RNA molecule, which helps cells respond to DNA damage.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!