Subsequent to the Phase I patient safety data review, a Safety Monitoring Committee authorised the enrolment for the consequential Phase II study.
Phase II trial is expected to enrol around fifty patients by early 2013 in the US.
Diffusion Pharmaceuticals CEO David Kalergis said the confirmation of TSC’s safety and dosing regimen has prompted the immediate expansion of treatment to a larger number of newly diagnosed GBM patients.
"The timely opening of Phase II means that statistically-powered efficacy data should be available on schedule later in 2013," Kalergis added.
The Phase II study will assess the effect of TSC when combined with radiation therapy in recently diagnosed GBM patients.
Endpoints include TSC’s effects on tumour regrowth based on MRI, the patient’s quality-of-life and overall survival.