OXFORD & NEWCASTLE, England -- (BUSINESS WIRE) -- e-Therapeutics plc (AIM:ETX) announces today that the US Food and Drug Administration (FDA) has approved the resumption of recruitment of new patients into the Company’s investigator-led Phase Ia study of ETS2101 in brain cancer, conducted at the University of California San Diego Moores Cancer Centre.
Recruitment was temporarily paused due to a drug storage issue which has been resolved to the satisfaction of the FDA, allowing the trial to continue to higher doses in further cohorts of patients. Patients who had received treatment with ETS2101 at the time of the temporary halt in recruitment were able to continue to be dosed in accordance with trial protocols.
Notes to Editors
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).
Preliminary results from the UK phase Ia trial and 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.
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.