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Abstract

Click to add/remove this article to your list of 'My Favorites' Improved Neurologic Exam and Nerve Conduction Velocities in Diabetic Neuropathy Patients Treated with Vascular Endothelial Growth Factor (VEGF) Zinc Finger Protein Activator (SB-509)

Year: 2007

Abstract Number: 0008-OR

Authors: MARK S. KIPNES, MICHAEL MERREN, WARREN DOUGLAS, SCOTT HAMILTON, YA-LI LEE, KAYE SPRATT, DALE ANDO, San Antonio, TX, San Anselmo, CA, Richmond, CA

Results: Twenty-four patients were treated with escalating doses from one to sixty milligrams (mg) of SB-509, a plasmid DNA expressing a zinc finger transcription factor for VEGF, in a Phase 1a/b clinical trial. Treatment Plan 1 consisted of administration of SB-509 in one leg and placebo in the contralateral leg at dose levels of 1, 5, 10, 15 and 30 mg. Treatment Plan 2 consisted of administration in both legs with either SB-509 or placebo at dose levels of 30 mg and 60 mg. Three placebo patients and three SB-509 patients were treated at each dose level in Treatment Plan 2. Patients were evaluated using the Total Neuropathy Score (TNS), a composite scale incorporating symptoms, neurologic exam, and nerve testing, nerve conduction velocities (NCV), and quantitative sensory testing (QST). A statistically significant improvement in motor NCVs was seen at dose level 6 (60mg) at the six-month time-point when comparing the sum of all motor NCV (2 peroneal and 2 tibial NCV per patient) improvements from baseline to placebo. The mean value of improvement in the SB-509 group (three patients) was 3.934 M/Sec compared to -0.52 M/sec in the placebo group (six patients) ( p < 0.0383). QST testing at six months showed a 43% improvement in vibration units from baseline at dose level 6 in the SB-509 group compared to 20% worsening in the placebo group (p< 0.0058). The TNS at six months showed improvement in this scale with a mean score of 1.675 in the SB-509 group compared to a mean improvement of 0.665 in the placebo group at dose level 6. Improvements in NCV included three patients with unmeasurable NCVs who, after treatment with SB-509, NCV returned and improved over the six-month follow-up. The dose level of 60 mg showed consistent improvements in the neurologic exam, QST and motor NCV. These improvements in neurologic endpoints suggest that SB-509 has novel regenerative potential for the reversal of nerve damage in Diabetic Neuropathy. The 60 mg dose level has been expanded to accrue a total of 24 patients to further evaluate the long term effects of a single treatment of SB-509 and a Phase 2 trial in mild to moderate diabetic neuropathy has been initiated.