Barcelona (Catalonia, Spain), October 6, 2015. Ability Pharmaceuticals, a drug development biopharmaceutical company specialized in oncology, today announced that it has received from the U.S. Food and Drug Administration (FDA), orphan-drug designation (ODD) for ABTL0812, its PI3K/Akt/mTOR pathway inhibitor, for the treatment of the pediatric cancer neuroblastoma and that it has received positive Scientific Advice from the European Medicines Agency (EMA) for its development in the same indication. These two regulatory milestones come after the ODD in neuroblastoma granted by EMA in April this year. ABTL0812 has successfully completed its Phase 1/1b trial in adult advanced cancer patients in Europe.
Carles Domenech, PhD, CEO of Ability Pharmaceuticals stated “We are very pleased with ABTL0812 gaining orphan-drug designation for neuroblastoma from the FDA, especially as it comes after the ODD granted by EMA earlier this year, as it would provide it with extra market exclusivity protection”. Carles Domenech continued “The EMA’s Scientific Advice for ABTL0812 represents a significant step toward the development of the compound in Europe”.
Jose Alfon, PhD, VP of Research and Development of Ability Pharmaceuticals said “Development of novel drugs directed at specific pathways is necessary to change the outcome of neuroblastoma and to improve its current therapeutic options”. José Alfon “We wish to thank the FDA for its fast review of the ODD application (just 6 weeks) and the EMA’s Scientific Advice and the ODD Working Party for its fast resolution and their input and guidance.”
The design of the clinical study for the Scientific Advice was done in collaboration with Dr. Soledad Gallego, Hospital Materno-infantil Vall d’Hebron in Barcelona, and Dr. Victoria Castel, Dr. Adela Cañete and Dr. Pablo Berlanga, Hospital Universitari I Politecnic La Fe in Valencia.
ABTL0812 is a first-in-class PI3K/Akt/mTOR (PAM) signaling pathway inhibitor with a novel mechanism of action, fully differentiated from other PAM inhibitors.
Neuroblastoma is a rare cancer of the nervous system that affects children and infants, mostly happening in the abdomen. It comprises 6-10% of all childhood cancers and causes about 15% of cancer-related deaths in children.
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