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news.e-Therapeutics has announced that it has received approval from Medicines and Healthcare products Regulatory Agency (MHRA) to recommence recruitment of new patients into its ETS2101 Phase Ia solid tumors trial being conducted at three centers in the UK.
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Recruitment was temporarily paused due to a drug storage issue which has now been resolved to the satisfaction of the UK Regulatory Body, allowing the trial to continue to higher doses in further cohorts of patients.
Patients already receiving treatment with ETS2101 at the time of the temporary halt in recruitment continued to be dosed in accordance with trial protocols.
In parallel, e-Therapeutics is working with the US investigator and regulatory body to enable the ETS2101 Phase Ia study in brain cancer at the University of California San Diego Moores Cancer Centre to resume recruitment and continue dose escalation. A further announcement on resumption of the study in the US will be made in due course.
The company expects to report data from the UK study within the first quarter of 2014 timeframe originally given, despite the temporary halt in recruitment.