Ability Pharmaceuticals, a drug development biopharmaceutical company specialized in oncology, has received from the US Food and Drug Administration (FDA), orphan-drug designation (ODD) for ABTL0812, for the treatment of pancreatic cancer. This regulatory milestone comes after the ODD in the pediatric cancer neuroblastoma granted by EMA and FDA in 2015.
In preclinical studies, ABTL0812 have shown efficacy in pancreatic cancer as single agent and synergistic effect (by 8 to 90 times) in combination with taxanes, platinum compounds and gemcitabine, with induction of tumor regression without increasing the toxicity associated with chemotherapy. First line therapy in patients with either locally advanced or metastatic pancreatic cancer includes these compounds, and administered in combination with ABTL0812 could greatly improve the treatment outcome.
ABTL0812 is currently in phase 2 as first line therapy in combination with chemotherapy in patients with endometrial or squamous lung cancer at Vall d'Hebron Institute of Oncology (VHIO) and Catalan Institute of Oncology (ICO) in Barcelona.
"Receiving Orphan Drug Designation for ABTL0812 is an important regulatory milestone achieved and an exciting step towards clinical advancement of this first-in-class therapy," said Carles Domenech, PhD, CEO of Ability Pharmaceuticals. "