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Investigational New Drug Application Filed for EW-A-401, Potential Treatment for Intermittent Claudication
The filing of the IND for the AVENGE trial (Activating Vascular ENdothelial Growth Factor) and other associated milestones trigger $1,000,000 in milestone payments from Edwards to Sangamo. This is the first IND filed for a therapeutic application of Sangamo's ZFP technology.
Pending FDA clearance of the IND, the Phase I/II AVENGE trial is scheduled to begin in the first half of 2004. The trial will be conducted at the Warren Grant Magnusen Clinical Center at the National Institutes of Health (NIH) in Bethesda, MD. Dr. Robert Lederman, a cardiologist and Investigator at the National Heart, Lung and Blood Institute who studies peripheral artery disease and the application of real-time MRI imaging in novel biological therapeutic cardiovascular interventions, will be the AVENGE trial's principal investigator. The trial is designed as a dose escalation study to measure the safety of EW-A-401 in patients with intermittent claudication, the most common form of PAD, which commonly manifests as leg muscle pain during exercise. In addition, the trial will explore the effectiveness of the therapeutic to improve blood flow, walking capacity, and quality of life.
In preclinical animal studies, EW-A-401 has proven effective in stimulating blood vessel growth and increasing blood flow in ischemic limbs. EW-A-401 is a polymer formulation of a plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor (ZFP TF), designed to upregulate the vascular endothelial growth factor A (VEGF-A) gene. VEGF-A has been shown to be an important factor for stimulating blood vessel growth.
"This is a significant step for Edwards and for our ZFP Therapeutic angiogenesis program," said Michael A. Mussallem, Edwards' chairman and CEO. "Sangamo's ZFP TF platform has unique therapeutic advantages that have the potential to provide a significant alternative for many of the more than 8 million Americans suffering from peripheral artery disease, and possibly other forms of advanced cardiovascular disease in the future."
"As the first human clinical trial of any ZFP TF, the AVENGE trial is an important step for Sangamo BioSciences and for the patients this technology has been designed to help," said Edward Lanphier, Sangamo's president and CEO. "We believe that our approach has significant advantages as it more closely mimics the natural process of vascular development. Our VEGF ZFP TF is designed to activate a patient's own VEGF-A gene, stimulate the production of multiple VEGF-A protein isoforms and the growth of histologically and functionally normal blood vessels."
Peripheral Arterial Disease Affects Between 8 Million and 10 Million Americans
According to the American Heart Association, PAD is estimated to affect between 8 million and 10 million people in the United States, although the condition is often under-diagnosed and undertreated. PAD is caused by blockages to the arteries that supply the legs with blood. The initial sign of PAD is leg muscle pain during exercise. As the disease progresses, patients can experience leg pain even when resting.
Source: Sangamo BioSciences, Inc. and Edwards Lifesciences Corporation