>>RICHMOND, Calif., Dec. 9 /PRNewswire-FirstCall/ -- During its 2003 Investor Conference, Edwards Lifesciences Corp. (NYSE: EW - News) updated investors on its program with Sangamo BioSciences, Inc. (Nasdaq: SGMO - News) to develop zinc finger DNA-binding protein transcription factors (ZFP TFs) for the treatment of peripheral arterial disease. Edwards said that they expect to file an investigational new drug (IND) application for its ZFP VEGF Therapeutic with the Food and Drug Administration (FDA) in the first quarter of 2004. The AVENGE trial (Activating Vascular ENdothelial Growth Factor A), scheduled to begin in the first half of 2004, will be the first human clinical trial of a ZFP TF designed to activate the endogenous vascular endothelial growth factor A (VEGF-A) gene.
"We are pleased to update our investors and the financial community on our ZFP Therapeutic angiogenesis program and its potential to provide a significant therapeutic alternative for patients suffering from severe peripheral vascular disease," said Michael A. Mussallem, Edwards' chairman and CEO. "We have made significant progress over the past year and look forward to the initiation of the Phase I clinical trial during the first half of 2004." The AVENGE trial is designed to evaluate the safety of the ZFP VEGF Therapeutic in patients with intermittent claudication, the most common type of peripheral arterial disease.
"The initiation of the first ZFP Therapeutic clinical trial -- the AVENGE trial -- will be an important milestone for our company and is the result of an enormous amount of dedication and hard work by Sangamo scientists and our colleagues at Edwards Lifesciences," said Edward Lanphier, Sangamo's president and CEO. "We look forward to continuing to work with Edwards and their clinical collaborators as the first ZFP Therapeutic moves into the clinic."
The collaboration between Sangamo and Edwards began in early 2000 and has focused on the research and development of Sangamo's ZFP TF technology to activate the endogenous VEGF-A gene for treating ischemic cardiovascular and peripheral vascular disease. The ZFP VEGF Therapeutic is a formulation containing plasmid DNA encoding the ZFP TF VEGF activator and a polymer. In the AVENGE clinical trial, the product will be administered by intramuscular injection into the leg of patients with intermittent claudication.
According to the National Heart Lung and Blood Institute (NHLBI), peripheral arterial disease, or PAD, is estimated to affect approximately 8 million people in the United States although the condition is often under diagnosed and under treated. The initial sign of PAD is intermittent claudication, which manifests itself as leg muscle pain during exercise. As the disease progresses, patients can experience leg pain even when resting. Eventually, some individuals with PAD have such poor blood flow that they develop leg ulcers that do not heal. If left untreated, the disease may lead to gangrene and to amputation of the limb.<<
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Wonder what's happening with the Wyeth program. Things seems to me moving more slowly over there. Obviously, the ONYX deal is toast, as it involved their adenovirus program, now dead.
Cheers, Tuck |
