[SB-509 for diabetic neuropathy goes to PII]
>>SAN FRANCISCO, Jan. 12 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (Nasdaq: SGMO - News) today announced that it will outline plans for a Phase 2 clinical trial of SB-509 in subjects with mild to moderate diabetic neuropathy at its presentation at the 24th annual JPMorgan Healthcare Conference. SB-509 is a novel ZFP Therapeutic(TM) designed to upregulate the expression of the patient's own vascular endothelial growth factor (VEGF) gene to protect and stimulate the regeneration of peripheral nerve function in diabetics suffering from peripheral neuropathy. Edward Lanphier, Sangamo's president and CEO, will present details of the study at the Conference at 1:30 p.m. today, Thursday, January 12, 2006 (PST).
"The progression of our first ZFP Therapeutic program into Phase 2 clinical trials is a significant clinical development milestone for Sangamo," said Mr. Lanphier. "We announced completion of enrollment of subjects in the Phase 1 study of SB-509 in November 2005 and did not observe any drug-related severe adverse events or dose-limiting toxicity. We expect to present data from the Phase 1 study at the American Academy of Neurology Meeting in San Diego in April 2006 and the American Diabetes Association Scientific Sessions in Washington, DC in June 2006. We are on track to initiate the Phase 2 study of SB-509 in the second half of 2006."
Sangamo is proposing to undertake a placebo-controlled, multi-treatment Phase 2 study in diabetic subjects with mild to moderate sensory/motor neuropathy. Subjects will be assigned to one of three treatment groups which will be administered a placebo, SB-509 every 2 months for three treatments or SB-509 every 3 months for three treatments. Subjects receiving SB-509 will be treated with the maximum tolerated dose of the ZFP Therapeutic by intramuscular injection in both legs. Safety will be monitored throughout the study. Clinical evaluations will include neurological examination and electrophysiological testing. The study will be conducted at multiple centers and subject enrollment is expected to take approximately twelve months.
About SB-509
SB-509 is administered as an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor (ZFP TF(TM)), designed to upregulate the VEGF-A gene. VEGF-A has been demonstrated to have direct neurotrophic and neuroprotective properties. In preclinical animal efficacy studies in a diabetic rat model, SB-509 has proven effective in protecting motor and sensory nerve function from disease-induced nerve damage.
About 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.<<
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