Diffusion Pharma Closes Deal; To Start Human Trials

Diffusion Pharmaceuticals LLC, a drug discovery and development company pioneering a revolutionary mechanism of action to treat life-threatening diseases, today announced that it has completed all animal toxicology studies required by the U.S. Food and Drug Administration (FDA) to file an investigational new drug (IND) application for its lead compound trans sodium crocetinate (TSC). The company also announced that it has completed a private financing round of $1.5 million, the proceeds of which will be used to support the company’s overall growth and move TSC into Phase I clinical trials in early 2007.

The recently completed toxicology tests were conducted at independent research laboratories, and were funded in part by a grant from the Office of Naval Research. The no adverse effect level (NOAEL) was about 500 times the efficacious dose in those animals, which is substantially higher than the proposed dose to be examined in humans.

“These studies show no appreciable toxicity of TSC, even at doses much greater than the proposed human dose,” said David G. Kalergis, Diffusion’s Chief Executive Officer. “Reaching this critical milestone has positioned us to prepare and file our IND application, which is currently being assembled by a team of Diffusion staff members and expert consultants,” he continued.

Assuming no significant FDA objections after filing, the company can proceed with its plans to initiate testing in healthy human volunteers. These studies are expected to begin in early 2007. Completion of these Phase I clinical trials will provide the foundation for further testing of TSC in populations suffering from such life-threatening conditions as hemorrhagic shock, stroke, respiratory disorders and cancer.

Additionally, Diffusion announced that it has closed a financing round in which it raised its target of $1.5 million in private equity, primarily from existing shareholders.

“These funds help move TSC into human testing, where we will have the opportunity to demonstrate the drug’s safety in humans and show proof of principal for the company’s novel technology,” said Kalergis. “Over the past 18 months, the company has also solved complex technical formulation issues, manufactured TSC to GMP (human) quality standards, and enhanced its intellectual property portfolio, all of which add value to the company and its platform technology.”