Diffusion Pharmaceuticals Announces Initiation of a Phase I/II Clinical Trial in Patients with Peripheral Arterial Dis...( September is National Vasc...),Health

September is National Vascular Disease Awareness Month

CHARLOTTESVILLE, Va., Sept. 3 /PRNewswire/ -- Diffusion Pharmaceuticals LLC, a clinical-stage drug-development company commercializing new drugs for the treatment of unmet medical needs, announced today that it has begun to enroll patients in a Phase I/II clinical trial of its lead drug candidate trans sodium crocetinate (TSC). The trial, designated NCT00725881 on the clinicaltrials.gov Website, is investigating TSC as a treatment for peripheral arterial disease (PAD) patients who experience the severe leg pain known as intermittent claudication. According to the PAD Coalition, approximately 8 million Americans suffer from the disease. Results from the trial are expected to be announced in early 2010.

This double-blinded, placebo-controlled trial will randomize up to 48 patients at five research sites in the U.S. Primary clinical endpoints of the study are peak walking time and claudication onset time, as demonstrated by exercise treadmill tests. Both endpoints are well-accepted by the medical community and regulatory authorities as reliable indicators of efficacy in intermittent claudication clinical trials. Safety and pharmacokinetic assessments are also being conducted during the trial.

"In addition to advancing a much-needed treatment for peripheral arterial disease patients, this Phase I/II study will also help demonstrate TSC's potential to treat other diseases related to cellular oxygen deprivation," says David G. Kalergis, JD/MBA, Chief Executive Officer of Diffusion Pharmaceuticals. "Such proof-of-concept in humans is a critical step in the advancement of our novel pharmaceutical and will support our plans to apply it to treatments for a broad range of unmet medical needs affecting millions of patients annually."

TSC is the company's lead candidate in a family of first-in-class compounds, representing a new approach to the treatment of conditions characterized b
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