Midatech Pharma has announced that it intends to continue with a planned dose escalation in the Phase I study of MTX-110 in recurrent glioblastoma (rGB) patients.
The latest development comes after a positive recommendation from the Data Safety Monitoring Board (DSMB) for the trial.
The company has also completed one month of treatment with MTX-110 in the first patient of the Phase I study.
The open-label, dose escalation Phase I MAGIC-G1 study has been designed for evaluating the safety and feasibility of intermittent infusions of MTX-110, which is given by convection enhanced delivery (CED) through an implanted refillable pump and catheter.
The company stated that the trial will recruit two cohorts, each with a minimum four participants.
The participants in the first cohort will receive MTX-110 alone while the second cohort will receive MTX-110 along with lomustine.
In the study, the first participant was given MTX-110 60uM through direct-to-tumour delivery and has received four 48-hour infusions for four weeks.
During this period, no treatment-associated adverse events were observed in the participant.
On 11 January, the DSMB reviewed the available data and recommended the dose escalation in the study to 90uM.
Midatech chief scientific officer Dr. Dmitry Zamoryakhin said: “This represents encouraging progress for the MAGIC-G1 study.
“As the study protocol is based on an accelerated dose escalation approach, with no adverse events seen in the first study patient, we are now able to escalate the dose to the concentration that is expected to be optimal in the development of MTX-110.
“Depending on the safety profile of the higher dose, the study will need to recruit a minimum of three more patients before possible progression to the next cohort.”
The company expects the treatment for the second patient to begin by the end of this month.