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Ability Pharmaceuticals Announces FDA-Orphan Drug Designation for ABTL0812 in Biliary Tract Cancer

November 7, 2018

Barcelona (Catalonia, Spain), November 7, 2018. Ability Pharmaceuticals, a drug development biopharmaceutical company specialized in oncology, announced today that it has received orphan-drug designation (ODD) for ABTL0812 from the US Food and Drug administration (FDA) for the treatment of biliary tract cancer.
 
The ODD program of the FDA grants special status to medicines and biological products intended to treat, diagnose or prevent rare diseases, which affect fewer than 200,000 people in the USA. This designation establishes a period of exclusivity for seven years of commercialization against competition, as well as certain incentives, such as federal grants, tax credits, a decrease in regulatory fees in the drug approval process, and clinical development advice.
 
The biliary tract refers to the organs and ducts that make, store and release the bile into the small intestine, and includes the liver, gall bladder and bile ducts located inside and outside the liver. Biliary tract cancer is a rare, highly fatal and heterogenous malignancy that arises from different locations within the biliary tree and comprises less than 1% of all human cancers and around 10-15% of all primary liver cancers. It is a life-threatening disease with a significant unmet medical need and treatment options are very limited due to its poor response to chemotherapy, radiation therapy and surgery conventionally used.
 
In preclinical studies, ABTL0812 has shown efficacy in biliary tract cancer as single agent and synergistic effect 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 biliary tract cancer includes these compounds, and administered in combination with ABTL0812 could greatly improve the treatment outcome. Besides, in the phase 1 study evaluating ABTL8012 as monotherapy with advanced cancer patients, one patient with biliary tract cancer remained stable for 18 months.
 
"We are particularly excited about the opportunity to provide benefit to patients with biliary tract cancer following the outstanding response of one patient that remained stable during 18 months in the phase 1 study with ABTL0812." said Carles Domenech, PhD, CEO of Ability Pharmaceuticals. "Receiving another orphan designation represents an important milestone as we evaluate to start the clinical program in biliary tract cancer and other cancer types."

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