Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

AOP Orphan Reports Positive Phase II Data of AOP2014/P1101

Published: Tuesday, December 11, 2012
Last Updated: Tuesday, December 11, 2012
Bookmark and Share
AOP Orphan announces results from phase II trial in PV at ASH Annual Meeting in Atlanta, U.S.A.

AOP Orphan Pharmaceuticals AG (AOP Orphan) has announced that based on promising phase II data it will initiate a phase III trial to support European Marketing Authorization of a novel mono-pegylated Interferon alpha 2b (AOP2014/P1101) for treatment of Polycythemia Vera (PV).

AOP Orphan has exclusively licensed AOP2014/P1101 for development and commercialization in the field of Myeloproliferative Disorders (MPDs) with the territory of Central Europe, CIS and Middle East from Pharmaessentia Corp. a biotech company based in Taiwan.

In contrast to other pegylated Interferons that require weekly administration, AOP2014/P1101 is applied only every other week, resulting in higher convenience and potentially improved tolerability, compliance and long term treatment outcomes.

Results from a phase II trial sponsored and conducted by AOP Orphan were presented yesterday Dec 9, 2012 in an oral presentation by Prof. Dr. Heinz Gisslinger from Vienna, Austria at this year´s prestigious annual ASH (American Society of Hematology) meeting held in Atlanta, U.S.A.

“Pegylated Interferons represent the most promising treatment modality for patients suffering from MPDs, even providing a chance for cure”, comments Prof. Gisslinger, University Hospital for Internal Medicine I, Hematology, General Hospital Vienna, Austria.

Data from 41 PV patients showed no dose limiting toxicities in a dose range from 50-540 μg given every two weeks, with a side effect profile in line with expectations based on other pegylated Interferons.

The overall response rate exceeded 90%, at 12 months of treatment 45-50% of patients showed a complete response based on normalization of hematological parameters.

A trend for normalization of spleen size was also observed at this relatively early time point. Importantly, after one year all patients were completely independent from phlebotomies.

Furthermore, JAK2 allelic burden was reduced significantly and sustained starting from week 28 of treatment. Molecular responses are regarded as important disease modification with the ultimate potential for cure.

“We are extremely happy with these promising results of AOP2014/P1101, and will take all efforts to make this novel treatment available to patients”, said Dr. Rudolf Widmann, CEO of AOP Orphan.

Based on these results AOP Orphan is initiating a pivotal phase III trial involving Polycythemia Vera patients. The trial termed PROUD-PV will commence early in 2013 and will include centers all across Europe.

Design and endpoints of this trial have been discussed between the European Medicines Agency EMA and AOP Oprhan to support a European Marketing Authorization, using EMAs centralized procedure.

AOP2014/P1101 has received Orphan Drug designation already in 2011.


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.


Scientific News
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
One Step Closer to Precision Medicine for Chronic Lung Disease Sufferers
A study led by University of North Carolina at Chapel Hill, and National Jewish Health, has provided evidence of links between SNPs and known COPD blood protein biomarkers.
Blood Pressure Drug May Boost Effectiveness of Lung Cancer Treatment
Researchers at Imperial College London have suggested that the blood pressure drug may make a type of lung cancer treatment more effective.
Insight into Eye Diseases
Scientists recreate zebrafish cell regeneration from retinal stem cells in mice.
Gene Regulation in Brain May Explain Repetitive Behaviors in Rett Syndrome Patients
The research could be a key step in developing treatments to eliminate symptoms that drastically impair the quality of life in Rett patients.
Heart Arrhythmia Caused by Mosaic of Mutant Cells
Researchers have solved the genetic mystery of an infant suffering from heart arrhythmia.
Iron Nanoparticles Make Immune Cells Attack Cancer
Researchers accidentally discover that nanoparticles invented for anemia treatment can trigger the immune system’s ability to destroy tumor cells.
Crispr Toolbox Expanded By Protein
Researchers have shown a newly discovered CRISPR protein has two distinct RNA cutting activities.
CES Score May Predict Response to Cancer Treatment
Researchers identify new type of biomarker that helps predict prognosis and response to several types of cancer treatment.
Uncovering Cancer’s ‘Invisibility Cloak’
Researchers discover cancer cell mechanism to become invisible to the body's immune system.
Scroll Up
Scroll Down
Skyscraper Banner

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
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!