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Biotech / Medical : Sangamo Therapeutics, Inc. SGMO -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (151)	1/10/2005 9:30:49 AM
From: tuck	Read Replies (1) \| Respond to of 368

>>RICHMOND, Calif., Jan. 10 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (Nasdaq: SGMO - News) announced today that it has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for SB-509, a novel therapeutic designed to protect and stimulate the regeneration of peripheral nerve function in diabetics suffering from peripheral neuropathy. "Our first IND filing is a major milestone for Sangamo and brings us closer to addressing a serious unmet medical need for the diabetic population," said Edward Lanphier, Sangamo's president and chief executive officer. "Currently, the only approved drugs being used treat the symptoms of diabetic neuropathy, there is nothing approved for therapy of peripheral nerve function. We believe that our ZPF Therapeutic, SB-509, may provide a new approach to treating this debilitating condition." SB-509 is an injectable formulation of 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 demonstrated to have direct neuroproliferative, neuroregenerative and neuroprotective properties. In preclinical animal efficacy studies, SB-509 has proven effective in protecting motor and sensory nerve function in a diabetic model and in stimulating nerve regeneration. Pending FDA review of the IND, a multicenter Phase I/II human clinical trial is scheduled to begin in the first half of 2005. The single-blind, dose-escalation study is designed to evaluate clinical safety of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. "The Phase I/II trial is powered primarily to assess the safety and maximum tolerated dose of SB-509. However, the subjects enrolled in the study will be diabetics suffering from diabetic neuropathy," said Dale Ando, M.D., Sangamo's vice president, therapeutic development and chief medical officer. "In a single visit, SB-509 will be administered to subjects via injection into one leg and placebo administered into the contra-lateral limb. This will allow us to evaluate effects of SB-509 on neurologic symptoms and electrophysiologic nerve function in the treated versus the untreated limb compared to baseline. The study is a multi-center trial involving sites experienced in treating diabetic neuropathy and there is great interest by these centers in participating in the initial trial of this novel approach and compound." Diabetic Neuropathy Diabetic peripheral sensory motor neuropathy is one of the most frequent complications of diabetes. Symptoms include numbness, tingling sensations and pain particularly in the toes or feet. This is gradually replaced by loss of sensation and motor function as nerve damage progresses. Ulcers and sores may appear on numb areas of the foot because pressure or injury goes unnoticed. Despite adequate treatment, these areas of trauma frequently become infected and this infection may spread to the bone, necessitating amputation of the leg or foot. More than 60% of non-traumatic lower-limb amputations in the United States occur among people with diabetes. In the period from 2000 to 2001 this translated to approximately 82,000 amputations. The American Diabetes Association estimates that there are approximately 18.3 million people with diabetes in the United States and that of those about 60% to 70% have mild to severe forms of neuropathy. According to the CDC, diabetes is becoming more common in the United States. From 1980 through 2002, the number of Americans with diabetes more than doubled.<< snip Cheers, Tuck