Diffusion Pharmaceuticals data from the Phase 1/2 clinical trial evaluating the safety and efficacy of trans sodium crocetinate (TSC) in newly diagnosed glioblastoma multiforme (GBM) has been published online in the Journal of Neurosurgery (JNS), the official publication of the American Association of Neurological Surgeons.
The article in JNS outlines 36.3% of the full TSC dose patients were alive at two years based on a Kaplan-Meier analysis, compared to reported survival rates for the standard of care (SOC) ranging from 27% to 30%. TSC, the Company's lead product candidate, is designed to target the tumor's hypoxic microenvironment, re-oxygenating treatment-resistant tissue and making the cancer cells more susceptible to the therapeutic effects of SOC radiation therapy and chemotherapy.
Trans Sodium Crocetinate with Temozolomide and Radiation Therapy for Glioblastoma Multiforme, outlines the results of a Phase 1/2 trial designed to evaluate the therapeutic effect of adding TSC to radiation therapy (RT) in 59 newly diagnosed GBM patients. In the open, single-arm trial, all patients received SOC RT and temozolomide (TMZ) beginning either after an initial resection or biopsy of the tumor to confirm GBM. TSC was administered at a dosage of 0.25 mg/kg IV around 45 minutes before each RT session three days per week during the 6 weeks of radiation therapy. Considerable tumor shrinkage was observed in many patients, with some tumors disappearing completely.