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				Sangamo BioSciences’ Partner Edwards Lifesciences Announces Status of the Phase I ‘AVENGE’ Clinical Trial RICHMOND, Calif., Dec. 9 /PRNewswire-FirstCall/ -- During its 2003 Investor Conference, Edwards Lifesciences Corp. (NYSE: EW) updated investors on its program with Sangamo BioSciences, Inc. (Nasdaq: SGMO) 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. About Sangamo Sangamo Biosciences, Inc is focused on the research and development of novel transcription factors for therapeutic gene regulation and repair. The company’s most advanced therapeutic development program involves the use of transcription factors for the treatment of peripheral arterial disease. Other therapeutic development programs are focused on ischemic heart disease, cancer, neuropathic pain, and monogenic diseases. Sangamo’s core competencies enable the engineering of a class of transcription factors known as zinc finger DNA binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TFs) that can control gene expression and consequently, cell function. Sangamo is also developing sequence-specific ZFP nucleases (ZFNs) for therapeutic gene correction as a treatment and possible cure for a variety of monogenic diseases such as severe combined immunodeficiency, sickle cell anemia and chronic granulatomous disease. For more information about Sangamo, visit the company’s web site at www.sangamo.com or www.expressinglife.com. About Edwards Lifesciences Edwards Lifesciences is a leader in advanced cardiovascular disease treatments and the number-one heart valve company in the world. Headquartered in Irvine, Calif., Edwards focuses on four main cardiovascular disease states: heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure. The company’s global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty. Additional company information can be found at www.edwards.com Edwards Lifesciences and Edwards are trademarks of Edwards Lifesciences Corporation. Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office. This press release may contain forward-looking statements based on Sangamo’s current expectations. These forward-looking statements include, without limitation, references to the research and development of novel ZFP TFs and ZFNs, applications of Sangamo’s ZFP technology platform and the filing of an IND application and initiation of human clinical trials. Actual results may differ materially from these forward-looking statements due to a number of factors, including technological challenges, Sangamo’s ability to develop commercially viable products and technological developments by our competitors. See the company’s SEC filings, and in particular, the risk factors described in the companyÆs Annual Report on Form 10-K and its most recent 10-Q. Sangamo assumes no obligation to update the forward-looking information contained in this press release. SOURCE Sangamo BioSciences, Inc. 12/09/2003 CONTACT: Elizabeth Wolffe, Ph.D., of Sangamo BioSciences, +1-510-970-6000, ext. 271, or ewolffe@sangamo.com; or Barry Liden, +1-949-250-5070, for Edwards Lifesciences Web site: http://www.sangamo.com (SGMO EW) back to top
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