e-Therapeutics plc has announced the start of the first clinical trial evaluating its compound ETS2101 as a treatment for cancer.
The phase I trial is enrolling patients with primary brain cancer (glioma) or cancer that has spread to the brain from other sites.
Led by Professor Santosh Kesari, MD, PhD, director of neuro-oncology at the UC San Diego Moores Cancer Center in La Jolla, California, the trial will enrol up to 24 patients. Successive cohorts of patients will receive increasing doses of ETS2101.
The primary objective is to evaluate safety and determine an appropriate dose for phase II development.
Secondary objectives include initial assessment of the drug’s activity, detailed study of its distribution within the brain and investigation of potential biomarkers of response. First findings are expected in late 2012 and final results during 2013.
“ETS2101 represents a novel approach to the treatment of cancer based on the new science of network pharmacology,” said Kesari. “We have seen encouraging results with this drug in our own laboratory and are excited that we can now offer it to patients in a clinical trial.”
e-Therapeutics’ Development Director, Steve Self, said: “Advancing ETS2101 into trials was one of our key goals following last year’s refinancing and refocusing of our business. We look forward with interest to seeing the first results from the clinic.”
The brain cancer trial is one of two studies in the phase I programme for ETS2101. A second, larger trial will start shortly in the UK and will evaluate the drug in patients with a wide variety of tumour types.
The decision to support a focused brain cancer trial in parallel with a broader phase I study reflects the particularly interesting data obtained from work with glioma cell lines and the ability of ETS2101, unlike many current cancer drugs, to cross the blood-brain barrier.