FDA Grants Orphan Drug Designation to Pancreatic Cancer Drug

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Ability Pharmaceuticals has received Orphan Drug Designation from the FDA for ABTL0812, its product designed to treat pancreatic cancer.

Ability Pharmaceuticals has received Orphan Drug Designation from the FDA for ABTL0812, its product designed to treat pancreatic cancer. Preclinical studies have shown the efficacy of ABTL0812 in pancreatic cancer as a single agent.

Previous research has also shown its synergistic effect in combination with taxanes, platinum compounds, and gemcitabine. Typically, first-line therapy in patients with locally advanced or metastatic pancreatic cancer includes these compounds. Administration of taxanes, platinum compounds, and gemcitabine, may significantly improve treatment outcome.

"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," Carles Domenech, PhD, CEO of Ability, said in a press release.

ABTL0812 can cause cell death by autophagy through the overexpression of TRIB3, an endogenous Akt regulator. The anticancer compound inhibits the PI3K/Akt/mTOR pathway without being a direct kinase inhibitor.

In phase 1/1b clinical trials, the product showed efficient safety and tolerability, compared to other inhibitors of the pathway. Ability began its first phase 2 trial with ABTL0812 in November 2016.

"ABTL0812 has shown to be extremely safe in patients during the phase 1b with initial efficacy and high activity on biomarkers", said Domenech, in a press release. "Additionally, the high efficacy observed in combination in preclinical models make us expect good results in the phase 2.”

The phase 2 trial is being conducted with 80 patients with advanced or recurrent endometrial cancer or squamous lung cancer.

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