Antisense Pharma Receives FDA Orphan Drug Designation for Trabedersen
News Oct 05, 2012
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."
Children With Congenital Zika Virus Infection Face Serious Challenges as They AgeNews
The report from the CDC is the first to describe the health and developmental effects of congenital Zika virus infection in children with microcephaly through 2 years of age.READ MORE
British Pharmacological Society’s Drug Discovery of the Year 2018 AnnouncedNews
A new medicine used to treat an ultra-rare inherited disorder which leaves babies without a fully functioning immune system has been named the British Pharmacological Society’s Drug Discovery of the Year 2018.READ MORE