DIFFUSION PHARMA BEGINS STUDY OF DRUG TO INCREASE OXYGEN LEVELS

Diffusion Pharmaceuticals began Phase I testing of trans sodium crocetinate (TSC), its lead drug candidate. TSC, which uses a novel mechanism of action to enhance the diffusion of oxygen into tissue, is being studied as a potential treatment for numerous diseases involving oxygen deprivation at the cellular level.

The Phase I safety trial is a double-blind, placebo-controlled, dose-escalation study in 48 healthy volunteers to assess TSC's pharmacokinetics and tolerability.

Diffusion completed FDA-required animal toxicology studies in the third quarter of 2006. These studies confirmed a safety profile for TSC, showing no appreciable adverse findings and documenting a very high no-observed-adverse-effect level.

In preclinical studies, TSC has been shown to increase the body's ability to use oxygen by up to 30 percent. In animals subjected to induced ischemic stroke, the area of damaged brain tissue is significantly reduced in TSC-treated animals compared with untreated animals. Also, animals suffering severe blood loss have a higher rate of survival if treated with TSC. In addition, TSC has been shown in animal models to increase the diffusion of oxygen into hypoxic cancerous tumor tissue, rendering the cancer more susceptible to radiation therapy.

The ability to enhance oxygen diffusion into hypoxic tissue represents a transformative technology, with potentially far-ranging implications for human health and the practice of medicine, according to the company. To date, Diffusion Pharmaceuticals has received $2.6 million in research grants from the Office of Naval Research to help fund the development of TSC.