e-Therapeutics plc has provided an update on the clinical trials of its cancer drug ETS2101.
Two phase I studies, one in patients with primary or secondary brain cancer and the other in patients with various solid tumours, remain on track to report final data in Q4 2013 and Q1 2014, respectively.
The phase I studies are designed to select appropriate doses for further trials, assess the safety and pharmacokinetics of ETS2101 and record any initial signs of anti-cancer activity.
They have a dose-escalating design in which successive cohorts of patients receive higher doses of drug until a maximum tolerated dose is identified.
To date 12 patients - two cohorts of three patients in each trial - have been treated. Some patients have completed multiple cycles of treatment with ETS2101; a number continue to be treated having received up to 11 weekly doses.
No patient in either study has so far experienced dose-limiting toxicities or other serious drug-related adverse effects.
Further dose escalation is therefore planned. It is too early to draw any conclusions about the likely maximum tolerated dose of ETS2101 or about other endpoints in the trials.
The brain cancer study is taking place at the UC San Diego Moores Cancer Center in La Jolla, California.
Two UK centres, St James’s University Hospital in Leeds and the Northern Centre for Cancer Care at the Freeman Hospital in Newcastle, are conducting the solid tumour trial.
Target enrolment is 24 patients in the brain cancer study and 45 patients in the solid tumour trial.
Professor Santosh Kesari, MD, PhD, director of neuro-oncology at the Moores Cancer Center, the investigator leading the brain cancer study, said “We are delighted to be evaluating the novel anti-cancer agent ETS2101 at our Center. Though we have so far exposed patients only to relatively low doses of the drug, we are reassured that the findings to date suggest good tolerability as we move to enrol additional patients at increasing doses.”
The next dose levels in the phase I trials will exceed those evaluated in earlier studies of the drug as a potential treatment for traumatic brain injury.
Stephen Self, Development Director at e-Therapeutics, commented, “We are conducting a thorough phase I programme to evaluate ETS2101. With recruitment of patients on track, we look forward to providing further updates in the first half of next year.”