Diffusion Pharmaceuticals Completes Enrollment in Phase II Clinical Trial of TSC in Brain Cancer

CHARLOTTESVILLE, Va.--(BUSINESS WIRE)--Diffusion Pharmaceuticals LLC today announced completion of enrollment in a Phase II clinical trial of trans sodium crocetinate (TSC), its lead compound for the treatment of cancer. The study enrolled 56 patients with newly diagnosed primary brain cancer (glioblastoma multiforme or GBM) at 18 major U.S. cancer institutions. GBM is a particularly deadly form of cancer, with only about 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 these survival times.

“We expect most of it to be placed with our existing shareholders, although we may add several additional accredited investors from our network.”

Open enrollment in the Phase II study began in November 2012, following successful completion of an earlier Phase I safety lead-in study. An independent Safety Monitoring Committee determined that no dose-limiting toxicities had occurred in Phase I, that TSC had been well tolerated in all patients, and that open enrollment in Phase II should be authorized.

“The speed of accrual for our GBM trial has been remarkable,” said David R. Jones, MD, Chief Medical Officer of Diffusion Pharmaceuticals. “This speaks to the huge unmet medical need in GBM and the desire of clinicians to identify much-needed new therapies and move them forward as rapidly as possible. We are also quite pleased at the safety profile of TSC and believe this played a significant role in the rapid rate of patient enrollment.”

Dr. James Larner and Dr. Jason Sheehan of the University of Virginia Medical Center are Study Co-Chairs for this trial. A summary of the study is available online at http://clinicaltrials.gov/ct2/show/NCT01465347?term=tsc&rank=5.

Separately, the Company announced that it is initiating a new financing round to fund further clinical development.

"About $6 million dollars of new convertible debt will be issued to accredited investors," 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."

About TSC

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. For more, see http://www.diffusionpharma.com/press-releases/.

About Diffusion Pharmaceuticals

Diffusion Pharmaceuticals is a clinical-stage company developing first-in-class drugs which target the many unmet medical needs characterized by oxygen deprivation (“hypoxia”) at the cellular level. These proprietary small molecules work by a novel mechanism of action that enhances the diffusion of oxygen selectively to hypoxic tissue. Potential breakthrough clinical applications include oncology, cardiovascular diseases, stroke and respiratory disorders. Diffusion Pharmaceuticals, which is privately held, is located in Charlottesville, Virginia.

For more information:

Visit the web site at www.diffusionpharma.com.