e-Therapeutics plc today announces that the investigator-led phase I trial of ETS2101 in brain cancer will continue into 2014. Five dose escalation steps have been completed without any drug-related serious adverse events and the investigator therefore intends to enrol further patients at higher dose levels.
The trial includes patients with advanced primary or secondary brain cancer that has recurred after treatment with established therapies. It is being conducted by Professor Santosh Kesari, MD, PhD, director of neuro-oncology at the UC San Diego Moores Cancer Center in La Jolla, California. The primary objective of the trial is to evaluate the safety of ETS2101 and establish an appropriate dose for further studies. Secondary objectives include initial assessment of the drug's activity and study of its pharmacokinetics (distribution in the body and brain).
Under the protocol, groups of patients are treated at successively higher doses until a maximum tolerated dose is found. Fifteen patients have now completed treatment at doses up to 24 mg/kg body weight. At all doses tested so far, ETS2101 has been generally well tolerated. No objective tumour responses have been reported based on the Response Assessment in Neuro-Oncology (RANO) Working Group criteria (see notes). Detailed data on safety and other endpoints will be submitted to a medical meeting when treatment and follow up of all patients is completed.
Professor Kesari said: "With an absence of safety concerns to date, we plan to evaluate at least one further dose level of ETS2101. Preliminary pharmacokinetic data from the study and non-clinical data also support this plan."
Stephen Self, Development Director at e-Therapeutics, added: "The brain cancer trial complements our UK phase I study in patients with various tumours and will help us decide on next steps with ETS2101. We appreciate the contribution of Professor Kesari and his patients to the investigation of the drug in an area of considerable unmet need and look forward to further findings from the trial."
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