Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Debiopharm Begins Phase 3 Trial

By Drug Discovery Trends Editor | July 30, 2012

Debiopharm Group, a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, announced the treatment of its first patient in a multicenter, open, non-comparative Phase 3 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 commercialised 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.

Date: July 24, 2012
Source: Debiopharm Group


Filed Under: Drug Discovery

 

Related Articles Read More >

Zoliflodacin wins FDA nod for treatment of gonorrhea
FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE