BARCELONA, Spain, December 13, 2017 /PRNewswire/ --
Ability Pharmaceuticals SL, a biopharmaceutical company, announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application which allows AbilityPharma to proceed with a phase 1/2a clinical trial of ABTL0812, its autophagy inducer via PI3K/Akt/mTOR pathway inhibition, in patients with endometrial cancer or squamous non-small cell lung cancer, in combination with paclitaxel and carboplatin as first-line therapy. AbilityPharma submitted its IND on October 31, 2017.
The trial is ongoing in Europe, where a total of 80 patients will be enrolled. Since November 2016, patients are being included in Vall d'Hebron Institute of Oncology VHIO (Barcelona), Institut Català d'Oncologia ICO (L'Hospilatet, Badalona and Girona in Catalonia), INCLIVA (València) and Hospital Universitario Virgen del Rocío (Sevilla). In early 2018 the trial will start recruiting patients in Institut Gustave Roussy (Paris), Centre Léon Bérard (Lyon) and Institut Paoli-Calmettes (Marseille), following the Clinical Trial Application (CTA) approval in France in October 2017.
Carles Domènech, Chief Executive Officer said: "FDA clearance of our IND application is an important milestone for AbilityPharma, which recognizes our efforts to start clinical development in the US during 2018". Gemma Fierro, Vice President of Clinical and Regulatory Affairs of AbilityPharma, stated: "After this major achievement, we are continuing with enthusiasm the preparations of additional INDs and CTAs with new clinical trials in both Europe and the US". José Alfón, VP, Research & Development said: "We have already received positive indications of interest from key investigators and clinical institutions to progress with the development of ABTL0812".
ABTL0812 causes autophagy-mediated cell death through the overexpression of TRIB3, a protein regulating Akt. It is a first-in-class, fully differentiated oral targeted anticancer compound inhibiting the PI3K/Akt/mTOR pathway without being a direct kinase inhibitor.
In preclinical cancer models ABTL0812 is efficacious as single agent with outstanding safety profile in a broad spectrum of cancer types. It also has synergistic effect with chemotherapy without increasing its toxicity.
In phase 1, ABTL0812 had excellent safety and tolerability compared to other inhibitors of the pathway, without dose-limiting toxicities. Remarkably 2 patients had extremely long disease stabilizations over one year (14 and 18 months). Additionally, ABTL0812 showed high efficacy on biomarkers of the pathway, with dose-response effect.
SOURCE Ability Pharmaceuticals, SL