E-therapeutics Regulatory News (ETX)

12 Sep 2012 07:00

e-Therapeutics plc (AIM: ETX) announces that it 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.

Professor Ruth Plummer, Clinical Professor of Experimental Cancer Medicine at the Northern Institute for Cancer Research and lead investigator for the phase I study at the Freeman Hospital, Newcastle, said: "ETS2101 derives from an interesting new approach to drug discovery known as network pharmacology. We are pleased to be involved in the first phase of clinical trials evaluating this drug as a potential treatment for cancer."

e-Therapeutics' CEO, Professor Malcolm Young, added: "The initiation of a second trial with ETS2101 reflects the growing momentum in our clinical development programme. We hope that the promising preclinical data supporting this drug will ultimately translate into benefits for patients and look forward to seeing the first findings from cancer trials later this year."

About ETS2101

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 the broader phase I cancer study described in this release.

About the ETS2101 study in solid tumours

Further details of the UK trial are available at www.clinicaltrials.gov

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 activity is focused in cancer and degenerative diseases of the nervous system and its development effort on three clinical candidates spanning cancer, psychiatric disorders and infectious diseases. 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 2012