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Clinical Trials

Date: 2016-11-22

Type of information: Initiation of the trial

phase: 2

Announcement: initiation of the trial

Company: Ability Pharmaceuticals (Spain)

Product: ABTL0812 (sodium 2-hydroxylinoleate)

Action mechanism:

kinase inhibitor/mtTOR inhibitor. ABTL0812 is a first-in-class Akt/mTOR signaling pathway inhibitor with a novel mechanism of action, fully differentiated from other PI3K/Akt/mTOR pathway inhibitors under development, and with cell death mediated by autophagy. In preclinical studies, ABTL0812 have shown efficacy in pancreatic cancer as single agent and synergistic effect (by 8 to 90 times) in combination with taxanes, platinum compounds and gemcitabine, with induction of tumor regression without increasing the toxicity associated with chemotherapy. Its unique mechanism of action was published at Clinical Cancer Research in 2015.
In preclinical cancer models ABTL0812 is efficacious as single agent with an excellent safety profile in a broad spectrum of cancer types: lung, endometrial, pancreatic cancer and neuroblastoma. In these models the compound has also synergistic effect with chemotherapy (taxanes, platinum compounds and gemcitabine) without increasing its toxicity. ABTL0812 is also active on cells resistant to chemotherapy or other targeted therapies, on tumor stem cells and inhibits metastasis formation. Preliminary results show promising immunomodulatory effects.

Disease: endometrial or squamous lung cancer

Therapeutic area: Cancer - Oncology

Country: France, Spain

Trial details:

Latest news:

* On November 22, 2016, Ability Pharmaceuticals announced the initiation of its first Phase 2 Clinical Trial with its novel targeted anticancer agent ABTL0812 to evaluate its efficacy and safety in combination with paclitaxel and carboplatin in 80 patients with advanced or recurrent endometrial cancer or squamous lung cancer as first-line therapy. The study will be conducted in Spain and France with Dr. Ana Oaknin at Vall d’Hebron Institute of Oncology (VHIO, Barcelona) as principal investigator for endometrial cancer and Dr. Ernest Nadal at Institut Català d’Oncologia (ICO, Hospitalet-Barcelona) as principal investigator for lung cancer. Dr. Jordi Rodon (also from VHIO) is the coordinating investigator.

Is general: Yes