Oxford and Newcastle, UK – 18 December 2014 – e-Therapeutics plc (AIM: ETX) is pleased to announce that the maximum tolerated dose (“MTD”) has been defined in the current UK trial Phase 1a advanced solid tumour study for ETS2101, the Company’s clinical stage anti-cancer asset.
The definition of the MTD follows completion of the most recent dose-escalation cohort and review by the Cohort Review Committee (“CRC”).
This event is a significant milestone for ETS2101. The protocol for the next phase of the project can now be fully defined and the dosing of the Phase Ib cohorts can commence, as planned, in Q1 2015. The Phase Ib studies will concentrate on specific solid tumours, the first two of which will be hepatocellular carcinoma (HCC) and pancreatic cancer.
Professor Ruth Plummer, the UK Principal Investigator, said: “This is a key point in the development of ETS2101 to have defined a safe maximum dose to take forward into the next phase of clinical studies.”
e-Therapeutics’ Development Director, Steve Self, said: “Having established the MTD, we can now investigate further the positive characteristics of ETS2101 as a potential cancer treatment for patients. We very much appreciate the efforts of Professor Plummer and all the clinical investigators, who have helped to bring us to this key point in the development programme for ETS2101.”
e-Therapeutics also announces the completion of an oral dosing study of ETS2101 in healthy volunteers. This study has provided data on pharmacokinetics, absorption and bioavailability via an oral route of administration up to high doses. These data and continuing work by the Company suggest that the development of an oral dose form of ETS2101 may be possible. The Company will undertake further preclinical investigation before deciding whether to progress an oral formulation into clinical development.
Further information about the MTD
As seen in cohorts at lower doses, the main side effect associated with ETS2101 is characterized by somnolence, rather than any of the side effects commonly associated with cancer chemotherapies.
At the final dose-escalation level, somnolence was more pronounced and resulted in some patients in the cohort withdrawing from treatment. The CRC concluded that side effects at the final dose-escalation level are limiting.
This result means that the MTD can now be defined at a dose at which these side effects were less pronounced, and at which no patients discontinued treatment with ETS2101 for drug-related reasons.
Notes for Editors:
ETS2101 is a synthetic cannabinoid identified by e-Therapeutics’ network pharmacology as a molecule with strong potential in cancer treatment. Preclinical studies provided evidence of activity in a wide variety of cancer cell lines. Three phase I studies of ETS2101 have been conducted in patients with primary or secondary brain cancers; in patients with a variety of advanced solid tumours; and an oral bioavailability study.
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.
Issued for and on behalf of e-Therapeutics by Instinctif Partners.
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Melanie Toyne-SewellManaging Partner