OXFORD & NEWCASTLE, England--(BUSINESS WIRE)--e-Therapeutics plc (AIM:ETX) announces today that it has received approval from MHRA to recommence recruitment of new patients into its ETS2101 phase Ia solid tumours trial being conducted at three centres in the UK.
Recruitment was temporarily paused due to a drug storage issue which has now been resolved to the satisfaction of the UK Regulatory Body, allowing the trial to continue to higher doses in further cohorts of patients. Patients already receiving treatment with ETS2101 at the time of the temporary halt in recruitment continued to be dosed in accordance with trial protocols.
In parallel, e-Therapeutics is working with the US investigator and regulatory body to enable the ETS2101 phase Ia study in brain cancer at the University of California San Diego Moores Cancer Centre to resume recruitment and continue dose escalation. A further announcement on resumption of the study in the US will be made in due course.
The Company expects to report data from the UK study within the Q1 2014 timeframe originally given, despite the temporary halt in recruitment.
ETS2101 (dexanabinol) is a synthetic cannabinoid identified by e-Therapeutics’ network pharmacology as a drug with potential in cancer treatment. Preclinical studies provided evidence of activity in a wide variety of cancer cell lines. Two phase I studies of ETS2101 are ongoing, one in patients with primary or secondary brain cancers (in the US) and one in patients with various advanced solid tumours (in the UK).
e-Therapeutics is an AIM-listed biotechnology company with a proprietary platform in network pharmacology, an innovative new approach to drug discovery based on advances in network science and chemical biology. The Company’s discovery and development activity is focused in cancer and disorders of the nervous system. e-Therapeutics is based at sites in Oxford and Newcastle, UK. For more information about the Company please visit www.etherapeutics.co.uk.