On August 31, 2015 Diffusion Pharmaceuticals LLC reported that Company CEO David G. Kalergis, MBA/JD, will be a guest speaker at the 2015 American Cancer Society CAN Virginia Research Breakfast, to be held September 17, 2015 at the Hilton Garden Inn, Glen Allen, Virginia (Press release, Diffusion Pharmaceuticals, AUG 31, 2015, View Source [SID:1234507363]). His topic will be the possible impact of the Company’s transformative new drug trans sodium crocetinate (TSC) on the treatment of cancer in years to come.
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The other speakers will be Dr. Gordon D. Grinder, Director, Massey Cancer Center, VCU; Dr. Thomas P. Loughran, Director, UVA Cancer Center; and Dr. Harold Sontheimer, Director Glial Biology, Disease and Cancer Center, VT Carilion Research Center.
Diffusion Pharmaceuticals recently announced results from its recently completed Phase 1/2 TSC GBM study in 59 patients with newly diagnosed glioblastoma (GBM), the most common and aggressive form of primary brain cancer. The results demonstrated that people who received TSC plus radiotherapy and chemotherapy benefited from an improvement in overall survival compared to the historical control group who received radiotherapy and chemo alone.
TSC plus radiotherapy and chemotherapy increased the patients’ chance of survival at two years by 37 percent compared to the control group. 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.
TSC currently has FDA Orphan Designations in GBM and metastatic brain cancer. In August 2015, agreement was reached with the FDA on a proposed single Phase 3 GBM study design which, if successful, could support TSC’s approval. Diffusion plans to initiate the study in 1H 2016.
In addition to moving TSC forward for the treatment of GBM, the Company is preparing it for clinical trials in other solid tumor cancer indications.