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

Clavis Pharma Provides Update on Pivotal LEAP Trial with CP-4126

Published: Monday, October 22, 2012
Last Updated: Monday, October 22, 2012
Bookmark and Share
64% of the 360 patients enrolled in the study are hENT1-low.

Clavis Pharma ASA reports that Clovis Oncology, its partner for CP-4126 (also known as CO-101), has been informed by the Independent Data Monitoring Committee that 64% of the 360 patients enrolled into the pivotal LEAP study were classified as hENT1-low.

The hENT1-low patients comprise the target population in which the primary survival endpoint of the LEAP trial, which is evaluating CP-4126 in metastatic pancreatic cancer patients, will be assessed.

The final hENT1 classification is in line with the previously reported results, announced in January 2012, and those from retrospective analyses (the 002 study) of hENT1 expression in pancreatic cancer tissues, that approximately two thirds of metastatic pancreatic patients are likely to be hENT1-low.

Studies have shown that hENT1-low patients derive little or no benefit from standard gemcitabine therapy (refs 1-4).

The final size of the hENT1-low population among the 360 patients in the fully enrolled LEAP study also confirms that the trial is well-powered.

Top-line results from the trial are expected to be announced in the fourth quarter of 2012, and if positive, regulatory filings are anticipated in the US and Europe in mid-2013.

Olav Hellebø, Clavis Pharma CEO, said: "The size of the hENT1-low population for the primary endpoint analysis in the LEAP study confirms our belief that there is a significant proportion of pancreatic cancer patients who are not likely to benefit from standard gemcitabine therapy and that CP-4126 could provide a new treatment option for these patients. We look forward to results of the LEAP study later in 2012 with great anticipation.”


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 3,200+ scientific posters on ePosters
  • More than 4,700+ 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

Clavis Pharma Announces Results of the LEAP Study of CP-4126 in Metastatic Pancreatic Cancer
Clavis Pharma continues to focus on elacytarabine and its Phase III CLAVELA study in leukaemia patients.
Monday, November 19, 2012
Clavis Pharma Announces Size of Initial hENT1-low Population in Pivotal LEAP Trial with CP-4126
65 percent of the initial 250 patients enrolled in the study are hENT1-low.
Monday, March 05, 2012
Clavis Pharma Announces the Completion of Study 002
Low hENT1 cut-off level determined for pivotal LEAP study of CP-4126 in patients with pancreatic cancer.
Friday, October 28, 2011
Clavis Pharma Second Quarter and First Half Report 2011
Clavis Pharma and Clovis Oncology expanded the LEAP study, evaluating CP-4126 vs. gemcitabine in pancreatic cancer patients.
Friday, August 26, 2011
Clavis Pharma Licenses LVT Compound CP-4033 to Translational Therapeutics for Development in Aggressive Thyroid Tumours
Clavis Pharma and Translational Therapeutics have entered into a strategic licensing agreement regarding the development and commercialization of CP-4033.
Monday, June 06, 2011
Scientific News
One Giant Leap for the Future of Safe Drug Delivery
Sheffield engineers make major breakthrough in developing silk ‘micro-rockets’ that can be used safely in biological environments.
New Cancer Drug Target Found in Dual-Function Protein
Findings from a study from TSRI have shown that targeting a protein called GlyRS might help to halt cancer growth.
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Fix for 3-Billion-Year-Old Genetic Error
Researchers at The University of Texas at Austin have developed a fix that allows RNA to accurately proofread for the first time.
Revealing the Genetic Causes of Bowel Cancer
A landmark study has given the most detailed picture yet of the genetics of bowel cancer — the UK's fourth most common cancer.
Self-Assembling Protein Shell for Drug Delivery
Made-to-order nano-cages open possibilities of shipping cargo into living cells or fashioning small chemical reactors.
Fighting Resistant Blood Cancer Cells
Biologists present new findings on chronic myeloid leukemia and possible therapeutic approaches.
Tumor Cells Develop Predictable Characteristics
Scientists have discovered that cancer cells at the edge of a tumor that are close to the surrounding environment are predictably different from the cells within the interior of the tumor.
Guided Chemotherapy Missiles
Latching chemotherapy drugs onto proteins that seek out tumors could provide a new way of treating tumors in the brain or with limited blood supply that are hard to reach with traditional chemotherapy.
SELECTBIO

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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!