Corporate Banner
Satellite Banner
Pharma Outsourcing
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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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

Debiopharm and EORTC Announce a Collaboration
Collaboration to investigate triptorelin for treatment of salivary gland cancers.
Thursday, January 14, 2016
Debiopharm and Solid Biosciences Announces Collaboration
Debiopharm to start pre-clinical animal studies in Duchenne Muscular Dystrophy with Solid Biosciences.
Thursday, September 10, 2015
Debiopharm Announces Phase III Positive Results for Triptorelin 6-month Formulation
Triptorelin 6-month formulation phase III trial demonstrates good efficacy in terms of pituitary and gonadal suppression and in arresting or reversing progression of clinical signs of puberty and slowing down of accelerated bone maturation in children with CPP.
Friday, May 22, 2015
Debiopharm Initiates Clinical Phase II Study to Evaluate Debio 1450
One year after the initiation of Phase I, Debiopharm has announced the start of clinical phase II for Debio 1450 in ABSSSI and presentation of new data at ECCMID.
Friday, May 01, 2015
Debiopharm Announces Progress in Phase I Single and Multiple Ascending Dose Study of Debio 1450
Debio 1450 - A highly potent anti-infective agent selectively active against Staphylococcus species.
Wednesday, October 15, 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
Debiopharm to Acquire Affinium’s Antibiotic Clinical Assets and Platform
Company acquire clinical and preclinical assets to identify and develop targeted antibiotics.
Wednesday, February 12, 2014
Debiopharm Announces Completion of Recruitment for Phase III Clinical Study in CPP
Completion of recruitment and results are expected in Q4 2014.
Monday, January 20, 2014
Curis and Debiopharm Announce Initiation of Phase I Dose Finding Study of Debio 0932
Designed to target advanced metastatic renal cell carcinoma, the study will determine the maximum tolerated dose of Debio 0932 in combination with everolimus.
Thursday, October 24, 2013
Debiopharm Initiates Phase I Dose Escalation Study with Debio 1347 (CH5183284)
First clinical phase I study in patients with advanced solid tumors with FGFR alterations.
Tuesday, September 03, 2013
Aurigene and Debiopharm Group™ Report Nomination of Debio 0617B
Debio 0617B is expected to enter clinical development in Q42014.
Monday, July 15, 2013
Shasun Pharmaceuticals and Debiopharm Enter Into Licensing Agreement
Agreement for the manufacturing and commercialization of Huperzine-A.
Wednesday, April 10, 2013
Debiopharm Announces First Patient Enrolled in Phase III Study
Phase III study for the rare disease central precocious puberty.
Monday, August 27, 2012
Debiopharm and Curis Announce Initiation of Phase Ib Expansion Study of Debio 0932
Company expects to initiate a combination Phase I/II study in NSCLC patients in the second quarter of 2012.
Tuesday, February 21, 2012
Debiopharm Group™ Starts Phase I Clinical Trial with Debio 0932
A targeted small molecule inhibitor of heat shock protein 90 for cancer treatment.
Wednesday, April 28, 2010
Scientific News
Therapy Halts Progression of Lou Gehrig’s Disease
Researchers at Oregon State University announced today that they have essentially stopped the progression of amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, for nearly two years in one type of mouse model used to study the disease – allowing the mice to approach their normal lifespan.
New Mechanism of Antitumor Action Identified
A team of UAB researchers and collaborators from the Catalan biotech company Ability Pharmaceuticals (UAB Research Park), have described a new mechanism of anti-tumour action, identified during the study and development of the new drug ABTL0812.
Experimental Combination Surprises with Anti-HIV Effectiveness
A compound developed to protect the nervous system from HIV surprised researchers by augmenting the effectiveness of an investigational antiretroviral drug beyond anything expected.
UTSW Researchers Identifies How Drugs Alter Pancreatic Cancer Cells
The findings were published in Cell Reports.
Researchers Identify Process that Causes Chronic Neonatal Lung Disease
Study determines how the NLRP3 inflammasome activates the protein Interleukin 1 beta.
Dengue Vaccine Enters Phase 3 Trial
Investigational vaccine to prevent ‘breakbone fever’ developed at NIH.
Trying to Conceive Soon After a Pregnancy Loss May Increase Chances of Live Birth
NIH study finds no reason for delaying pregnancy attempts after a loss without complications.
BRCA1 Deficiency Increases the Sensitivity of Ovarian Cancer Cells to Auranofin
An anti-rheumatic drug could improve the prognosis for ovarian cancer patients exhibiting a deficiency of the DNA repair protein BRCA1, a study suggests.
Shingles Vaccine Helps Protect Older Patients with End-stage Renal Disease
Kaiser Permanente study advances knowledge about safety and effectiveness of vaccine commonly given to older adults.
AMRI Acquires Whitehouse Laboratories
Strategically extends AMRI's analytical offerings in rapidly expanding area of outsourcing services.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!