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Early and very limited results from e-Therapeutics’ (LON:EXT) phase I trial of cancer drug candidate ETS2101 have thus far revealed no “dose limiting toxicities” or other adverse effects.
So far, 12 patients have been given low doses of the treatment in phase I studies, which are designed to test the safety and tolerability. The amount administered will be increased over time.
Researchers are assessing two groups – one with primary or secondary brain cancer, the other with solid tumours. Both sets of patients have advanced cancer.
The former, which will ultimately enrol 24 patients, remains on track to report its findings in the final quarter of 2103, while the latter, which will take in 45 patients, is expected to yield results in the first three months of 2014.
The company revealed that some patients have completed “multiple cycles of treatment with ETS2101 and a number continue to be treated having received up to 11 weekly doses”.
Professor Santosh Kesari, of the Moores Cancer Center in California, is the investigator leading the brain cancer study.
He said: “We are delighted to be evaluating the novel anti-cancer agent ETS2101 at our centre.
“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.”
Daniel Elger, chief financial officer, said there had been no serious side effects from the first two levels of dosing.
He said phase I trials are primarily about safety and establishing the maximum tolerated dose of the drug, although they also look for preliminary evidence of whether the drug has effects against the cancer.
“It’s good news that patient enrolment is on schedule as this gives us confidence we can meet the timelines we’ve given for reporting results from the trials.” Elger said.