Phase I patient safety data was reviewed by a Safety Monitoring Committee, which authorised the open enrolment for a consequential Phase II study.
The Phase II trial is expected to enrol around fifty patients by early 2013 in the US.
Diffusion Pharmaceuticals CEO David Kalergis said the safety confirmation 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 said.
The Phase II trial is designed to assess the effect of TSC when combined with radiation therapy in recently diagnosed GBM patients.
Endpoints of the study include TSC’s effects on tumour regrowth as determined by MRI, the patient’s quality-of-life during and after the treatment, and overall survival at one and two years after treatment.
TSC received an FDA orphan drug status for its use in GBM in 2011, and an orphan drug designation for its use in brain metastases is awaiting.
Image: Diffusion Pharmaceuticals is enroling patients in Phase II trial of trans sodium crocetinate. Photo: Courtesy of CrystlBluPersuason.