Adventrx Pharmaceuticals has announced plans to develop ANX-188 as an adjunct to thrombolytics in acute limb ischemia (ALI), a complication of peripheral arterial disease.
Eight to 12 million people in the US suffer from peripheral arterial disease, which affects arteries outside the brain and heart and often causes the blockage of arteries in the lower extremities.
Adventrx Pharmaceuticals development senior vice president R Martin Emanuele said; "Data from experimental models demonstrate the potential for ANX-188, when used alone or in combination with thrombolytics, to improve outcomes for patients with thrombotic arterial disease, whether manifesting as acute limb ischemia, stroke or some other variant."
Data from the company’s clinical studies in animals and humans suggests that ANX-188 can shorten time-to-thrombolysis, improve blood flow, delay re-occlusion and reduce reperfusion injury, each of which may improve the effectiveness of existing thrombolytic agents.
Thrombolytic agents such as tissue plasminogen activator (tPA) are used to treat acute complications of peripheral arterial disease, heart attack and stroke.
Adventrx Pharmaceuticals Chief Medical Officer Santosh Vetticaden said the company is planning to initially evaluate the potential of ANX-188 in acute limb ischemia.
"Near-term goals include seeking orphan drug designation for ANX-188 in ALI, meeting with FDA to discuss our development plan in ALI and, assuming FDA agrees with the plan, initiating a Phase II, clinical proof-of-concept study in late 2013 or early 2014," Vetticaden said.
"Currently, we estimate that third-party costs to conduct this study will be approximately $2m and that it will take approximately 15 to 18 months to enrol.
"Ultimately, we plan to leverage the data in ALI to find a partner to develop ANX-188 in larger indications within arterial disease, such as stroke."