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Diffusion Pharmaceuticals Announces Initiation of a Phase I/II Clinical Trial in Patients with Peripheral Arterial Disease (PAD)
Date:9/3/2008

y oxygen deprivation (hypoxia) at the cellular level. Using a novel mechanism of action, TSC enhances the diffusion of oxygen through blood plasma, increasing the rate of oxygen transport and thus treating the symptoms of hypoxia at their source.

In 2007, the Company successfully completed a Phase I safety study of TSC. This randomized, double-blind, placebo-controlled, dose-escalation study in 40 subjects evaluated the tolerability and pharmacokinetics of an intravenous bolus injection of TSC in healthy human subjects. The study demonstrated that TSC is well tolerated, and raised no significant clinical safety issues in humans at doses higher than the doses being used in ongoing clinical trials.

About Multi-Center Trial in Peripheral Arterial Disease Patients:

This randomized, double-blinded, placebo-controlled trial will consist of four cohorts of 12 patients each, to be enrolled sequentially over an escalating range of TSC dosages. Subjects in the study will receive injections of either TSC or placebo intravenously once daily for five consecutive days. Safety and tolerability will be evaluated in a safety review of each cohort before any patients are enrolled into the next cohort. Patients will be evaluated during the study for safety parameters and for clinical endpoints using a treadmill test at prescribed time points. Follow-up assessments will occur at 5, 14 and 30 days after the last dose. The objectives of the study are to evaluate the safety and pharmacokinetics of multiple doses of TSC; establish a dose-response relationship and effect of TSC on peak walking time and claudication onset time in intermittent claudication patients; determine the effect of TSC on potential hypoxia biomarkers; and evaluate the impact of TSC on quality-of-life parameters using the assessments measured in the Walking Impairment Questionnaire routinely used in PAD research. More information on this trial, designated NCT00725881, can be found on the clinicaltr
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SOURCE Diffusion Pharmaceuticals LLC
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