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

Antisense Pharma Receives FDA Orphan Drug Designation for Trabedersen

Published: Friday, October 05, 2012
Last Updated: Friday, October 05, 2012
Bookmark and Share
TGF-ß2 inhibitor has gained market exclusivity in the USA for a third aggressive cancer indication.

Antisense Pharma GmbH has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation for its investigational oncology antisense compound trabedersen to treat malignant melanoma.

Previously, trabedersen has received Orphan Drug designation by the European EMA and the US FDA in high-grade glioma (malignant brain tumor) in 2002 and in advanced pancreatic cancer in 2009.

Dr. Philippe Calais, Chief Executive Officer of Antisense Pharma comments: "We are delighted that with this most recent designation by the FDA, Trabedersen has now orphan status for three different cancer indications. With the orphan status and the associated marketing protection, we have achieved a core milestone for the long-term commercial success of our oncology lead compound trabedersen."

Dr. Hubert Heinrichs, Chief Medical Officer of Antisense Pharma elaborates: "Malignant melanoma is a very aggressive disease with a high need for innovative, effective and well-tolerated treatment options. We are confident that traberdersen will provide new hope to patients that suffer from malignant melanoma. Recently published results of our Phase I/II Study1 with traberdersen demonstrated excellent tolerability and initial encouraging survival data in patients with advanced tumors. We are currently evaluating further clinical development of traberdersen in malignant melanoma, preferably together with a potential partner."


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 4,800+ 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

Antisense Pharma Changes Name to Isarna Therapeutics
Development efforts focused on next generation oligonucleotides to treat cancer capitalizing on long-standing experience in TGF-ß.
Monday, September 30, 2013
Antisense Pharma Presents Trabedersen Phase I/II Complete Data at ASCO
Trabedersen demonstrated excellent safety combined with encouraging survival in patients with advanced pancreatic cancer and malignant melanoma.
Tuesday, June 05, 2012
Antisense Pharma Internationalizes Management Board
Dr. Philippe Calais appointed Chief Executive Officer.
Tuesday, May 15, 2012
Antisense Pharma Completes Round of Financing Worth Approximately 8 Million Euro
Effective July, 2011, Antisense Pharma’s founder and CEO, Dr. Karl-Hermann Schlingensiepen, will now be a member of the supervisory board and will focus on the company’s strategy as a consultant.
Thursday, July 07, 2011
Antisense Pharma’s Trabedersen in Malignant Brain Tumors: Phase IIb Data Published in Neuro-Oncology
Antisense Pharma have announced that their international, randomized and active-controlled Phase IIb study G004-AP 12009, has been published in the official journal of the American Society for Neuro-Oncology (SNO).
Tuesday, November 02, 2010
Scientific News
Liquid Biopsies: Miracle Diagnostic or Next New Fad?
Thanks to the development of highly specific gene-amplification and sequencing technologies liquid biopsies access more biomarkers relevant to more cancers than ever before.
Discovered Through ‘Big Data’ Analysis
Researchers at the SBP have identified over 100 new genetic regions that affect the immune response to cancer.
New Therapeutic Targets For Small Cell Lung Cancer Identified
Researchers at UTSW Medical Center have identified a protein termed ASCL1 that is essential to the development of small cell lung cancer and that, when deleted in the lungs of mice, prevents the cancer from forming.
Liquid Biopsies Treating Ovarian Cancer
Researchers have discovered a promising monitor and treat recurrence of ovarian cancer. Detecting cancer long before tumours reappear.
Cell Cargo Ships in Near Future?
Virus-inspired container design may lead to cell cargo ships following construction of ten large, two-component, icosahedral protein complexes.
Uncovering a New Principle in Chemotherapy Resistance in Breast Cancer
The NIH study has revealed an entirely unexpected process for acquiring drug resistance that bypasses the need to re-establish DNA damage repair in breast cancers that have mutant BRCA1 or BRCA2 genes.
Understanding Treatment Resistant Melanoma
Researchers have determined how advanced melanoma becomes resistant; a development toward developing treatments.
Liquid Biopsies: DNA Size Matters
Study finds circulating tumour DNA can be distinguished from healthy DNA through fragment size identification.
Unravelling the Roots of Insect’s Waterproof Coating
Researchers have identified the genes that control cuticular lipid production in Drosophila, by performing an RNAi screen and using Direct Analysis in Real Time and GC-MS.
Identifying Cancer Drug Targets Using 3D-Modelling
Researchers are now able to model genetic mutations manipulation of proteins that can potentially drive cancer.
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
4,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!