• ETS2101 well tolerated at all six dose escalations with no serious adverse events attributed to the drug
• No further occurrence of dose-limiting fatigue
• Early evidence of possible halting of tumour progression
Oxford and Newcastle, UK – 31 March 2014 – e-Therapeutics plc (AIM: ETX) announced today interim results from its phase Ia UK study evaluating the safety, dosing and anti-tumour activity of ETS2101 (dexanabinol) in patients with advanced solid tumours.
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.
The UK Clinical Investigators therefore intend to continue to enrol further patients at higher dose levels, and to continue to escalate until a maximum tolerated dose has been established. The observation that progression of the tumour might be affected by higher doses of ETS2101 is clearly one that the UK Principal Clinical Investigator is keen to explore further.
Professor Ruth Plummer, trial Principal Investigator at the Bobby Robson Cancer Centre at the Freeman Hospital in Newcastle upon Tyne said: “In the last two cohorts (15mg/kg and 22mg/kg), we have seen a number of patients who have come onto the study with advanced progressive disease and have stayed on study in some cases for over five months. This suggests that the compound may be halting tumour progression as measured by RECIST criteria. We are excited by this initial observation, and are very keen to continue to escalate the dose to confirm this and explore if further possible anti-tumour effects will be found.”
e-Therapeutics’ Development Director, Steve Self, said: “The latest findings from ETS2101 are encouraging. We will continue to dose escalate to find the maximum tolerated dose and further explore the observations of possible activity in cancer patients that we have seen in the most recent two cohorts. These data, along with the US phase I data, are important in helping us to refine the next steps with this compound. We very much appreciate the contribution of Professor Plummer and all our investigators and their patients to this study, and are looking forward to further findings from the trial as it extends to higher doses.”
Notes To Editors
About the ETS2101 study in solid tumours
The study is being conducted at three UK Centers, with the Principal Investigator being Professor Ruth Plummer at the Bobby Robson Cancer Centre at the Freeman Hospital in Newcastle upon Tyne.
The primary objective of the dose escalation study is to evaluate the safety of ETS2101 and establish an appropriate dose for further studies. Secondary objectives include initial assessment of the compound’s activity, and study of its pharmacokinetics (its distribution in the body). The trial recruits patients with any of a wide range of advanced solid tumours, who have progressed through the Standard of Care treatment and have progressive disease as measured by RECIST criteria.
Under the protocol, cohorts of three patients are treated at successively higher doses until a maximum tolerated dose is found. To date, 23 patients have completed treatment up to 22mg/kg, with one of the six patients in the two cohorts at the highest doses remaining on study at this time. At all doses tested, ETS2101 has been well tolerated. One partial response (which may or may not be attributable to the drug) has been reported to date (in cohort one). In more recent cohorts at higher doses, patients have been remaining on study for significantly longer periods of time. Detailed safety and other endpoints are being monitored closely.
Further details of the UK trial are available at http://www.clinicaltrials.gov
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 and one in patients with various advanced solid tumours.
About RECIST criteria
This is a radiological method of tumour evaluation which acts as a marker of disease progression. Target tumours that grow by less than 25% as measured by the criteria laid down in RECIST1.1 over a defined period are described as “stable disease”.
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.
To contact the e-Therapeutics team at Instinctif Partners, email e-Therapeutics@instinctif.com
Melanie Toyne-SewellManaging Partner