8 May 2014 07:00
e-Therapeutics announces recruitment resumes into
US phase I ETS2101 brain cancer trial
Oxford and Newcastle, UK, 8 May 2014 - 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.
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Contacts:
e-Therapeutics plc
Malcolm Young / Steve Medlicott
Tel: +44 (0) 1993 880000
www.etherapeutics.co.uk
Panmure Gordon (UK) Limited
Fred Walsh / Duncan Monteith
Tel: +44 (0) 20 7886 2500
www.panmure.com
Instinctif Partners
Melanie Toyne Sewell / Stefanie Bacher
Tel: +44 (0) 20 7457 2020
Email: e-therapeutics@instinctif.com
CommStrat Group (US)
Ted Agne
Tel: (+1) 781 631 3117
Email: edagne@comstratgroup.com
Notes to Editors
About ETS2101
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.
About e-Therapeutics
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.
Copyright Business Wire 2014