Clinical Trials Resource Center

Intermittent Claudication

November 22, 2010

Diffusion Pharmaceuticals issued positive results from a phase I/II trial of Trans Sodium Crocetinate (TSC) for the treatment of walking impairment due to peripheral artery disease (PAD). This randomized, double-blinded, placebo-controlled study enrolled 48 subjects with intermittent claudication symptoms from PAD. The subjects received TSC at doses of 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75 and 2.0 mg/kg or placebo. Study medication was dosed intravenously as a bolus injection once daily for five consecutive days. Data showed a notable dose response for peak walking time on a graded treadmill test at several TSC dosing levels after five days of treatment. There was a clinically meaningful improvement for the subjects who received 1.50 mg/kg of TSC of nearly three times the improvement observed with the placebo group. TSC was safe and well-tolerated at all doses.

June 25, 2007

AnGes announced positive results from a phase III trialof AMG0001 for the treatment of Critical Limb Ischemia (CLI).This randomized, placebo-controlled, double blind study enrolled 40 subjects inJapan. Of the subjects, 27 received AMG 0001 8mg (4mg x 2) and 13 received placebo.The primary endpoints, improvement of rest pain ((VAS (Visual Analog Scale)) orischemic ulcer size, at 12 weeks post dosing, showed statistical significance,with a 70.4% improvement in the AMG0001 group versus a 30.8% improvement in theplacebo group (p=0.014). Treatment was well tolerated, with adverse reactionssimilar between the groups. Based on the results, AnGes stopped the trial earlyto prevent potential ethical issues against the placebo group subjects. The companyplans to move forward with filing for Japanese and US approval.

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