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news.US-based biopharmaceutical firm Mast Therapeutics has initiated a proof-of-concept Phase II clinical trial of its lead product candidate MST-188 in combination with recombinant tissue plasminogen activator (rt-PA) to treat patients with acute lower limb ischemia (ALI).
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MST-188 has already secured FDA orphan drug designation for the treatment of ALI, an acute complication of peripheral arterial disease that describes a sudden decrease in perfusion of a limb, typically in the legs, that often threatens viability of the limb.
About 60 patients will be enrolled in the trial from about 15 sites within and outside the US with Rutherford Category IIa and IIb acute lower limb ischemia receiving catheter-directed rt-PA and compare a high and low dose of MST-188 against rt-PA alone.
Mast Therapeutics senior vice president of development Martin Emanuele said numerous experimental models, as well as clinical studies, show that MST-188 facilitates thrombolysis, repairs damaged cell membranes, and improves microvascular blood flow.
"When combined with rt-PA, we believe these activities will translate into faster thrombolysis in patients with ALI and in other acute thrombotic events such as stroke, while at the same time reducing vessel re-occlusion, reperfusion injury, and tissue necrosis," Emanuele said.
The trial’s primary objectives are to evaluate the safety and efficacy of MST-188 in combination with rt-PA and whether MST-188 results in more rapid thrombolysis and tissue perfusion.
Secondary objectives of the trial include evaluation of the clinically-meaningful benefit of MST-188 in combination with rt-PA by measures such as duration of thrombolytic therapy, amputation-free survival, target limb re-interventions, and the need for endovascular or open surgical re-interventions.
MST-188 is a cytoprotective, hemorheologic, anti-inflammatory and anti-thrombotic agent that has potential utility in diseases or conditions characterized by microcirculatory insufficiency.