On July 23, 2019 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions, reported that based on favorable safety data in a 19-patient dose-escalation run-in study, the Data Safety Monitoring Board (DSMB) has recommended the continuation of the Company’s Phase 3 clinical trial with trans sodium crocetinate (TSC) in inoperable glioblastoma multiforme (GBM) patients (Press release, Diffusion Pharmaceuticals, JUL 23, 2019, View Source [SID1234538535]). 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.
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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."
About the INTACT Trial
The INTACT clinical trial is an open-label, randomized, controlled, Phase 3 safety and efficacy registration trial in inoperable GBM patients. It will screen 300 patients and enroll 264, with the expectation that results from 236 patients will be available for analysis. Enrolled patients will be randomized in a 1:1 ratio into control and treatment groups. Patients in the control group will receive SOC radiation and chemotherapy, including the standard temozolomide injections. Patients in the treatment group will receive injections of TSC prior to these SOC treatments. The SOC regimen for GBM is temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest, followed by 6 cycles of high-dose temozolomide treatment.
The study will compare overall survival at two years between the two groups. Up to 100 clinical sites are expected to participate.
Further details about the trial protocol are available at www.clinicaltrials.gov.