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New Neuropathy Treatment To Regenerate Nerve Function
New Neuropathy Treatment To Regenerate Nerve Function -- Posted by Gumbo on 02-02-05 19:01
New Neuropathy Treatment To Regenerate Nerve Function
A novel therapeutic designed to protect and stimulate the regeneration of
peripheral nerve function in diabetics suffering from peripheral neuropathy
Sangamo BioSciences Files New Drug Application for ZFP Therapeutic to Treat
Diabetic Neuropathy. Sangamo announced that it has submitted an
investigational new drug application (IND) to the U.S. Food and Drug
Administration (FDA) for ZFP, a novel therapeutic designed to protect and
stimulate the regeneration of peripheral nerve function in diabetics
suffering from peripheral neuropathy.
"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," stated their CEO,
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."
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