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Diffusion Reaches Interim Endpoint and Initiates Funding

Friday, May 16, 2014  
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Diffusion Pharmaceuticals LLC has reached the one year interim endpoint for its Phase I/II clinical trial of lead compound trans sodium crocetinate (TSC), 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.”

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