AbilityPharma announces FDA approval of Phase 1/2 trial of ABTL0812 for patients with advanced metastatic pancreatic cancer

Ability Pharmaceuticals, a member of the UAB Research Park, has announced that the United States Food and Drug Administration has approved a phase 1/2 study to assess the efficacy and safety of ABTL0812 in combination with gemcitabine and nab-paclitaxel in patients with advanced metastatic pancreatic cancer at first line therapy and as maintenance therapy.

19/02/2018

This milestone comes after FDA approval of the Investigational New Drug (IND) for endometrial cancer or squamous non-small cell lung cancer last December, which validated the protocol of the Phas 1/2 study with ABTL0812 currently ongoing in Spain and France.

In preclinical studies, ABTL0812 has shown efficacy in pancreatic cancer models as single agent, and in combination with nab-paclitaxel and gemcitabine, with synergistic effect, with induction of tumor regression without increasing the toxicity associated with chemotherapy. First-line therapy with ABTL0812 in combination with chemotherapy could greatly improve the treatment outcome.

Carles Domènech, PhD, Chief Executive Officer said: “FDA approval of the phase 1/2 trial in pancreatic cancer with ABTL0812 is an important step forward in the development of our novel drug with the potential to become a transformational therapy for patients affected with this cancer”. “ We are now working with the medical community to start the clinical development of ABTL0812 in this condition”, Carles Domènech added.