Diffusion Pharmaceuticals, a clinical-stage drug-development company, has begun to enroll patients in a Phase I/II clinical trial of its lead drug candidate, trans sodium crocetinate.
The trial, designated NCT00725881, is investigating trans sodium crocetinate (TSC) as a treatment for peripheral arterial disease (PAD) patients who experience the severe leg pain known as intermittent claudication. 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 US. Primary clinical endpoints of the study are peak walking time and claudication onset time, as demonstrated by exercise treadmill tests. Safety and pharmacokinetic assessments are also being conducted during the trial.
This randomized 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 five, 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.
Also in 2008, Diffusion Pharmaceuticals will initiate a proof-of-concept Phase I study evaluating the effect of TSC on the oxygen levels of brain tumors in patients with high-grade glioma.
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