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
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Clovis Expands CP-4126 Trial

By Drug Discovery Trends Editor | June 29, 2011

Clavis Pharma ASA, the Norwegian cancer drug development company, announces that Clovis Oncology, Inc, its development partner for CP-4126, has expanded the ongoing observational study to determine the patient stratification parameters in the pivotal LEAP clinical trial with CP-4126.

CP-4126 is a new, patented, lipid-conjugated form of the anti-cancer compound gemcitabine developed by Clavis Pharma using its lipid vector technology. It is currently being investigated in a pivotal clinical study (known as LEAP) in patients with newly diagnosed metastatic pancreatic cancer; the primary end point is overall survival in low hENT1 patients receiving CP-4126 compared to gemcitabine. This study is being conducted by Clovis Oncology.

Low hENT1 levels have been correlated to poor clinical outcome of gemcitabine treatment, the standard treatment for many solid tumours (see below). hENT1 (human Equilibrative Nucleoside Transporter 1) is a protein expressed on the surface of certain cancer cells that has been shown to be important for the uptake and efficacy of gemcitabine.

In 2Q 2011, Clovis Oncology initiated an observational analysis (study 002) of hENT1 expression in pancreatic cancer patients using a biomarker assay to define the criteria for low and high hENT1 levels as part of the CP-4126 programme. The criteria for a cut-off for low hENT1 levels will be established using randomised, controlled cancer tissue samples from patients with known disease outcome, and who have been treated with gemcitabine or 5-FU. Patients enrolled in the LEAP study will be prospectively stratified as hENT1-high or hENT-low based on the outcome of this analysis and before clinical data from the trial are known.

Since the initiation of the observational study, Clovis Oncology has developed a second, improved hENT1 biomarker assay, which is currently being validated. Therefore, the results of the analysis, which were due in 1H 2011, are now anticipated in 2H 2011 such that the hENT1 cut-off to be used to stratify patients in clinical trials investigating CP-4126 is expected to be established by 4Q 2011.

Date: June 29, 2011
Source: Clavis Pharma ASA 


Filed Under: Drug Discovery

 

Related Articles Read More >

Korean team reports all-in-one cancer nanomedicine in pre-clinical studies
Nektar’s Phase 2b atopic dermatitis win triggers 1,746% analyst target surge, but legal tussle with ex-partner Lilly could complicate path forward
Dupixent approved to treat bullous pemphigoid
EVEREST lead investigator on why Dupixent sets a new bar for treating coexisting CRSwNP and asthma
“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
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE