Date: 2014-02-05
Type of information: Clinical trial autorization
phase: 1
Announcement: clinical trial authorization
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 models ABTL0812 has shown activity similar or higher than reference compounds, but with higher safety. Additionally, ABTL0812 potentiates the antitumor effect of several standards of care chemotherapeutic agents, while still maintaining its safety profile. Moreover ABTL0812 keeps its potency and efficacy in tumor cells that have become resistant to standard chemotherapy or targeted therapies, with superiority over other PI3K/Akt/mTOR inhibitors.
Disease: advanced solid tumors
Therapeutic area: Cancer - Oncology
Country: Spain
Trial
details: This first-in-human clinical trial is a dose-escalation study of ABTL0812, the trial will determine the adequate dose of ABTL0812, that will be administered orally daily to patients with advanced solid tumors. (NCT02201823)
Latest
news: * On February 5, 2014, Ability Pharmaceuticals has announced the approval from the Spanish Medicines Agency (AEMPS) to initiate a Phase I/Ib clinical trial of the novel anticancer drug ABTL0812 in patients with advanced cancer. ABTL0812 inhibits the proliferation of cancer cells through the inhibition of the mTORC1/C2 pathway. It will be administered to patient orally once daily. The drug is aimed to the treatment of patients with advanced cancer such as lung or pancreatic, for whom the options of treatment are limited. The primary objectives of the trial with ABTL0812 will be to establish the safety profile and the appropriate dose for future phase II clinical trials. The secondary objective of the trial is the evaluation of ABTL0812’s efficacy, including also novel non-invasive biomarkers.
