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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.


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.