Clinical Trial Results

In 2015, Diffusion Pharmaceuticals completed a Phase 1/2 study of trans sodium crocetinate (TSC) in 59 patients with newly diagnosed primary brain cancer (GBM). The results demonstrated that people who received TSC plus radiotherapy and temozolomide chemotherapy benefited from a substantial improvement in overall survival (OS) compared to the historical control group who received radiotherapy and temozolomide chemotherapy alone.

TSC plus radiotherapy and chemotherapy increased the patients’ chance of survival at two years by 37 percent compared to the historical control. In the subgroup of patients considered inoperable, the chance of survival at two years for those who received TSC was increased by over 100 percent. No negative safety findings were observed in the TSC GBM study and no serious adverse events were attributed to TSC in any patient.

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Health‐related quality of life measures including global health status and physical, social and motor functioning remained stable or improved in most TSC‐treated patients during the trial. No serious negative safety findings attributed to TSC were observed in the study and adverse events were consistent with those seen in previous trials of GBM featuring radiation therapy and temozolomide chemotherapy.

These results, considered by experts to be clinically meaningful, have been submitted to a major medical journal for publication in 2016.