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XBiotech Reports Positive Phase II Interim Analysis Results in Vascular Disease
Date:11/20/2012

t the Cincinnati VA Medical Center. 

Patients enrolled in the study had claudication or calf pain at rest and hemodynamically significant occlusion of the SFA, with average lesion lengths of 15 cm. The primary efficacy endpoint, measured by vessel patency, evaluates the ability of MABp1 to reduce restenosis by blocking vascular inflammation after revascularization using balloon angioplasty, atherectomy or stent placement.  The incidence of MACE was the secondary endpoint based on the high incidence of cardiovascular-related morbidity and mortality in patients requiring revascularization of the femoro-politeal artery.

At the time of the interim analysis, 42 patients had enrolled in the study—including 21 patients in the control arm receiving standard of care (SOC) and 21 patients in the treatment arm receiving SOC and MABp1.  Patients were treated with MABp1 and evaluated for 12 months. Adverse events reported in both groups appeared to be related to underlying disease, and no obvious side effects from MABp1 treatment were observed.

"The challenge we face in endovascular surgery today is keeping vessels open after being treated by endovascular interventions," said lead investigator Hosam El-Sayed MD, Ph.D., RVT, Assistant Professor of Cardiovascular Surgery, Weill Cornell Medical College, Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, Texas. "While the emerging technology drug–eluting stents and balloons have helped to address the high rate of restenosis, they are limited to local delivery of drugs within the vessel.  As a systemic drug, MABp1 is capable of addressing both restenosis within the vessel, as well as the underlying cardiovascular and cerebrovascular complications associated with vascular disease.  This represents an entirely new treatment approach and a paradigm shift in current thinking.  Based on the encouraging interim results, incorporating this simp
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