Diffusion Pharmaceuticals Successfully Completes First Cohort in Brain Cancer Trial
Diffusion Pharmaceuticals LLC has successfully completed the first cohort in a Phase I/II clinical trial testing its lead compound trans sodium crocetinate (TSC) in newly diagnosed primary brain cancer patients. All patients in this cohort were treated at the University of Virginia Medical Center in Charlottesville, Virginia.
Patients enrolled in the first cohort were treated with TSC for three doses a week over three weeks during radiation therapy. TSC was dosed in conjunction with the existing standard of care (radiation and chemotherapy) for newly diagnosed primary brain cancer, also known as glioblastoma multiforme or GBM.
An independent Safety Monitoring Committee has authorized enrollment to begin in Cohort 2 after determining that no dose-limiting toxicities had occurred and that TSC was well-tolerated in these patients. Eleven more institutions have been opened for the second cohort, which has begun enrolling patients. An additional eight institutions will be initiated during the third quarter of 2012, for a total of 20 institutions to enroll 59 patients in the study by the first quarter of 2013.
“The recommendation from the independent Safety Monitoring Committee confirms the excellent clinical safety profile seen previously in TSC,” said David G. Kalergis, Diffusion Pharmaceuticals’ CEO. “Enrollment of the second cohort is already underway, and we are on schedule to meet our goal of full study enrollment and efficacy evaluations during the next year.”
Dr. James Larner and Dr. Jason Sheehan of the University of Virginia Medical Center are Study Co-Chairs for this trial.