Ability Pharma pancreatic cancer drug granted orphan drug designation in United States
<p>The candidate is currently undergoing phase II clinical trials with a group of 80 patients with endometrial or squamous lung cancer</p>
Biotech firm Ability Pharma, led by Carles Domènech, recently announced its candidate ABTL0812 to treat pancreatic cancer has received orphan drug designation from the US FDA. This milestone comes on the heels of it being designated an orphan drug for pediatric neuroblastoma by the EMA and the FDA in 2015.
The ABTL0812 molecule to fight cancer is currently being tested in 80 patients with endometrial or squamous lung cancer at Vall d’Hebron Institute of Oncology, Catalan Institute of Oncology and other centers in Spain and France. This phase II clinical trial aims to determine how effective it is as first-line therapy in combination with chemotherapy with paclitaxel and carboplatin.
In preclinical studies, the candidate has been proven effective in fighting pancreatic cancer as a single agent and synergistic effect in combination with taxanes, platinum compounds and gemcitabine, shrinking tumors without increasing toxicity associated with chemotherapy.
The FDA orphan drug designation, granted to drugs to treat rare diseases that affect fewer than 200,000 people in the United States, comes with market exclusivity of seven years, as well as incentives, federal subsidies, tax credits and lower regulatory fees during the drug-approval process.