VM BioPharma, the U.S. division of ViroMed, announced that the Food and Drug Administration (FDA) has granted Fast Track designation for the investigational drug, VM202, for the potential treatment of Amyotrophic Lateral Sclerosis (ALS).
Study data from a Phase 1/2 trial of VM202 in ALS is anticipated for publication in the second half of 2016. The primary endpoint was the safety and tolerability of VM202, with secondary endpoints including measures of the ALS Functional Rating Scale (ALSFRS-r) and other efficacy parameters.
In addition to an ALS indication, the company is also exploring the use of VM202 for painful diabetic neuropathy (DPN), critical limb ischemia, chronic non-healing ischemic foot ulcer in diabetic patients, and coronary artery disease (CAD). Phase 2/3 trials have either been completed or are currently ongoing for these potential indications.
VM202, a novel gene therapy, produces hepatocyte growth factor (HGF) protein, which induces angiogenesis and acts as a neurotrophic factor to stimulate regeneration of damaged nerve cells.
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