NATAP: New Drug for Diabetuc Neuropathy

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Sangamo BioSciences Initiates Phase 2 Clinical Trial of Novel Therapy for Diabetic Neuropathy

PR Newswire Europe (inc. UK Disclose) - Nov. 29, 2006

RICHMOND, Calif., Nov. 29 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. today announced that the company has initiated a multi-center Phase 2 clinical trial of SB-509 for diabetic neuropathy (DN). The clinical trial is a double-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. 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.

The Juvenile Diabetes Research Foundation (JDRF) is providing up to $3 million of financial support for the study. Regulatory acceptance of the trial triggered the first milestone payment from the Foundation.

"Based on the extremely encouraging data that we have observed in our Phase 1 studies, we are very pleased and excited to initiate this Phase 2 trial," said Dale Ando, M.D., Sangamo's vice-president of therapeutic development and chief medical officer. "Our primary objective in the Phase 2 study will be to determine the effect of treatment with SB-509 on the clinical profile of neurologic damage in association with DN. In our Phase 1 studies we observed anecdotal clinical improvements after a single treatment in quantitative sensory testing (QST) which measures perception of vibration, and improvements in average total neuropathy score (TNS), a composite of several measurements including neurologic exam, QST, nerve conduction velocity (NCV) studies and neurologic symptoms."

Activation of VEGF-A has been demonstrated to have potent and 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 diabetes-induced nerve damage. Data from Sangamo's Phase 1 trials demonstrate that a single treatment of SB-509 was well-tolerated and that no drug-related severe adverse events were observed. Injection site reactions were the most common adverse events reported in both treated and placebo groups and were mild and reversible. Importantly, subjects in the Phase 1b study and in the top dose cohorts of the Phase 1a trial were treated within the pharmacologically effective dose range that had been demonstrated to be efficacious in preclinical animal studies, and anecdotal improvements in clinical symptoms were observed.

"This is Sangamo's first Phase 2 trial, an important milestone that demonstrates that we are making significant progress in translating our zinc finger DNA-binding protein (ZFP) technology into a novel class of drugs capable of addressing unmet medical needs," said Lanphier, Sangamo's president and CEO. "We commence this study on a strong scientific, clinical and economic foundation, having reported positive safety findings and preliminary, anecdotal evidence of clinical improvement from our Phase 1 studies of this drug. Currently, patients with DN are treated with analgesics and antidepressants to control pain symptoms. In contrast, SB-509 is designed to address the underlying problem of nerve damage and therefore could have a profound impact on the lives of patients suffering with diabetic neuropathy. It is also gratifying to have the commitment and support of an organization of the stature of JDRF as we advance the clinical development of this drug."

About the Phase 2 study of SB-509

The clinical trial is a double-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. The trial will be conducted at multiple sites. SB-509 is an injectable formulation of plasmid DNA that encodes a ZFP TF, designed to upregulate the VEGF-A gene.

Approximately 100 subjects will be enrolled into the trial. Subjects will be randomized to one of two groups in a 2:1 ratio. The larger group (approximately 66 subjects) will be treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into the lower limb every 2 months. The remaining group (approximately 33 subjects) will receive an equal volume of placebo on the same schedule. Each subject will receive a total of three treatments (Day 0, 60 and 120). Subjects will receive injections in a distribution pattern that targets the major peripheral nerves in the legs and feet.

The symptoms of diabetic peripheral neuropathy and any changes that occur during the trial will be evaluated based on neurological examination data, electrophysiological testing data, subject neurological questionnaire, and subject pain assessment. Specifically, investigators will use the following tests: the visual analog scale for pain intensity (VASPI), total neuropathy score (TNS) to assess signs and symptoms of the condition. A composite scoring system is widely regarded by neurologists as the most comprehensive approach to evaluating changes in nerve health. In addition to qualitative assessment of symptoms, the TNS includes electrophysiological testing using nerve conduction velocity (NCV) to assess the rate at which a nerve can conduct an electrical signal, and quantitative sensory testing (QST) with the Vibratron II instrument, to assess the threshold of detection of vibration. In addition, skin biopsies will be taken to evaluate the direct therapeutic effect of SB-509 on nerve regrowth. This test is a very sensitive marker of DN severity and may provide an important mechanistic marker for efficacy.

The trial is expected to take approximately 12 months to screen and enroll subjects, four months for subject treatment and a further 8 months for subject follow-up. Individuals interested in participating in this trial should visit http://www.clinicaltrials.com/ or the Sangamo website at http://www.sangamo.com/ .

About Diabetic Neuropathy

Diabetic peripheral neuropathy is one of the most frequent complications of diabetes. Symptoms include numbness, tingling sensations and pain particularly in the toes or feet. This may gradually evolve to 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 may go unnoticed. Despite treatment, these areas of trauma may become infected and this infection may spread to the bone, necessitating amputation of the lower leg. More than 60 percent 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. According to the Centers for Disease Control, the incidence of diabetes in the United States is growing rapidly. From 1980 through 2002, the number of Americans with diabetes more than doubled.

About Sangamo BioSciences, Inc.

Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic development program is currently in a Phase 2 clinical trial for evaluation of safety in patients with diabetic neuropathy. Phase 1 clinical trials are ongoing to evaluate a ZFP Therapeutic for peripheral artery disease. Other therapeutic development programs are focused on ischemic heart disease, neuropathic pain, cancer and infectious and monogenic diseases. Sangamo's core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN) for therapeutic gene modification as a treatment for a variety of monogenic diseases, such as X-linked SCID and hemophilia, and for infectious diseases, such as HIV. Sangamo has established several Enabling Technology Agreements with companies to apply its ZFP Technology to enhance the production of protein pharmaceuticals. For more information about Sangamo, visit the company's web site at http://www.sangamo.com/ .

This press release may contain forward-looking statements based on Sangamo's current expectations. These forward-looking statements include, without limitation, references to the clinical trials of SB-509, the research and development of novel ZFP TFs and ZFNs, clinical trials and therapeutic applications of Sangamo's ZFP technology platform. Actual results may differ materially from these forward-looking statements due to a number of factors, including uncertainties relating to the timing of completion of the Phase 2 clinical trial of SB-509, whether the results of the Phase 2 clinical trial will validate the safety and efficacy of SB-509, 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 company's 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.

Sangamo BioSciences, Inc.

CONTACT: Wolffe, Ph.D. of Sangamo BioSciences, Inc.,

+1-, ext. 271, or ewolffe@...; or of Burns

McClellan, Inc., +1-

Web site: http://www.sangamo.com/