May 15, 2014
Diffusion Pharmaceuticals LLC today announced that it has reached the one year interim endpoint for its Phase I/II clinical trial of trans sodium crocetinate (TSC), the Company’s lead compound for the treatment of cancer. The study enrolled 59 patients with newly diagnosed primary brain cancer (glioblastoma multiforme or GBM) at 18 major U.S. cancer centers. GBM is a deadly cancer, with only 61% of patients alive one year after diagnosis and about 26% at two years. The Diffusion study is designed to determine whether adding TSC to the current standard-of-care treatment for GBM can significantly improve survival.
At the one year interim mark, the Diffusion clinical trial results surpass the historical standard of care. Further information has been submitted for presentation in connection with a major oncology medical meeting being held later in the year.
“We are encouraged by the signals of safety and efficacy seen to date in the trial,” said David R. Jones, MD, Chief Medical Officer of Diffusion Pharmaceuticals. “We remain cautiously optimistic as we approach the critical two year endpoint in March, 2015, which will produce the definitive study results.”
Dr. James Larner and Dr. Jason Sheehan of the University of Virginia Medical Center are Study Co-Chairs for this trial.
Separately, the Company announced that it is initiating a new financing round to fund further clinical development of TSC.
“Five million dollars of new convertible debt will be issued to accredited investors over the next six weeks,” said Diffusion CEO David G. Kalergis. “We expect most of it to be placed with our existing shareholders, although we may add several additional accredited investors from our network.”
Trans sodium crocetinate (TSC) is a proprietary, first-in-class oxygen diffusion enhancing compound currently formulated for intravenous administration. Based on a novel mechanism of action, TSC safely re-oxygenates hypoxic tissue without causing hyper-oxygenation of normal tissue. Published studies demonstrate a tripling of survival and superior tumor control when TSC is combined with radiation and chemotherapy in animal models of primary brain cancer. The US Food and Drug Administration has granted Orphan Designation for TSC in the treatment of both GBM and brain metastases. The potential patient population for TSC in these two brain cancers is about 183,000 patients annually.
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Visit the web site at www.diffusionpharma.com.