Date: 2014-03-31
Type of information:
phase: 1
Announcement: results
Company: e-Therapeutics (UK)
Product: ETS2101 (dexanabinol)
Action
mechanism: ETS2101 (dexanabinol) is a synthetic cannabinoid previously studied in trauma patients. Its anti-cancer potential was identified by e-Therapeutics’ network pharmacology platform. This revealed the drug’s potential to overcome cancer cells’ ability to evade apoptosis – the suicide mechanism that is normally triggered if cells become dysfunctional – through impact on the network of proteins controlling the process. Preclinical work has provided empirical evidence that the drug induces apoptosis in cancer cells and has demonstrated broad activity against cancer cell lines. Findings of particular interest in experiments with brain cancer lines led the Company to support early evaluation of the drug in this setting in parallel with this broader phase I cancer study.
Disease: advanced solid tumours
Therapeutic area: Cancer - Oncology
Country: UK
Trial
details:
Latest
news: * On March 31, 2014, e-Therapeutics has announced interim results from its phase Ia UK study evaluating the safety, dosing and anti-tumour activity of ETS2101 (dexanabinol) in patients with advanced solid tumours. Following the completion of six dose escalation steps up to 22mg/kg, ETS2101 was found to be well tolerated at all doses by all patients with no serious adverse events attributed to the drug reported. In an earlier cohort, a single incident of dose-limiting fatigue was noted, but has not been repeated in any other patient to date. In addition, analysis of data from the trial indicates that tumour development might be being retarded by the activity of ETS2101 in patients who joined the trial with progressive disease with a wide variety of tumour types. The UK Clinical Investigators therefore intend to continue to enrol further patients at higher dose levels, and to continue to escalate until a maximum tolerated dose has been established. The observation that progression of the tumour might be affected by higher doses of ETS2101 is clearly one that the UK Principal Clinical Investigator is keen to explore further. * On January 24, 2014, e-Therapeutics has announces that recruitment of patients into both of the ongoing phase I trials of ETS2101 has been halted temporarily because of a practical issue with stored drug for the trials. Patients already receiving treatment with ETS2101 will continue to be dosed in accordance with trial protocols. Relevant regulators are being notified and the Company is taking steps to enable recruitment to resume as soon as possible. Two phase I studies of ETS2101 are ongoing: an investigator-led study in brain cancer at the UC San Diego Moores Cancer Center in La Jolla, California and a study at three UK centres that is enrolling patients with a variety of solid tumours. A report of data from the UK study had been expected in Q1 2014; this may be delayed by the temporary halt in recruitment. * On September 12, 2012, e-Therapeutics has started a second phase I clinical trial of its anti-cancer drug ETS2101. This trial will enrol up to 45 patients with a variety of solid tumours at two UK centres, St James’s University Hospital in Leeds and the Northern Centre for Cancer Care at the Freeman Hospital in Newcastle. It complements an investigator-led phase I study of ETS2101 in brain cancer that began in San Diego, California during June. Like the brain cancer study, the UK trial has a dose-escalating design in which groups of patients receive successively higher doses of the drug. The primary objective is to evaluate the safety of ETS2101 and identify an appropriate dose for phase II development. Secondary objectives include initial assessment of the drug’s activity and evaluation of its distribution within the body (pharmacokinetics). Final results from the trial are expected during 2013.
