Diffusion Pharmaceuticals Reports Safety Data for Phase 3 INTACT Study in Glioblastoma Patients

Diffusion Pharmaceuticals (NASDAQ:DFFN) has announced safety data results in its Phase 3 clinical trial of trans sodium crocetinate in inoperable glioblastoma multiforme (GBM) patients.

As quoted in the press release:

In addition, the DSMB has recommended that the highest dose administered, 1.5 mg/kg of TSC, be used during the adjuvant treatment period of the Phase 3 INTACT trial. The INTACT (INvestigating Tsc Against Cancerous Tumors) trial is comparing standard of care (SOC) radiation therapy and chemotherapy plus TSC against SOC alone.

The dose-escalation run-in study explored four doses of TSC:  0.25, 0.5, 1.0 and 1.5 mg/kg. Patients received SOC radiation therapy and temozolomide chemotherapy with an intravenous injection of TSC administered before those treatments. Adverse events seen were consistent with the natural history of newly diagnosed inoperable GBM patients.

The DSMB concluded that no adverse safety signal had been observed, and unanimously recommended continuing the study as planned using the 1.5 mg/kg dose of TSC during the adjuvant chemotherapy period.

“We are pleased this run-in study is consistent with our previous findings as to the safety of TSC,” said David Kalergis, Diffusion’s chief executive officer. “We are hopeful these run-in safety data, along with compelling data from our Phase 2 study showing a nearly four-fold improvement in survival at two years with TSC when used with radiation therapy in the inoperable GBM patient subgroup, will attract the attention of potential partners for continuing the development of the GBM indication. GBM patients have a poor prognosis and limited treatment options. We believe TSC has great potential to improve these patients’ outcomes and extend survival.”

Click here to read the full press release.