Study Start Date: 09/01/2006
Study End Date: 12/31/2009

Prosaptide^(TM) TX14(A) in Feline Diabetic Neuropathy

Neuropathy is a devastating complication of diabetes mellitus that affects up to 50% of the human population with this disease. Diabetic cats also develop a neuropathy that is comparable in many respects to human diabetic neuropathy. In recent studies of feline diabetic neuropathy (Mizisin et al 2002; Mizisin et al 2007), neurological dysfunction ranged from very mild to severe, with plantigrade posture when standing or walking the most striking abnormality. As in human diabetic neuropathy, motor and sensory nerve function is impaired in diabetic cats. Evidence that neurotrophic support is altered in experimental diabetes has focused attention on the use of exogenously administered neurotrophic factors to treat diabetic neuropathy.

Prosaptide^(TM) TX14(A) is a secreted injury-repair protein capable of promoting nerve regeneration and has shown efficacy in treating nerve dysfunction in experimental diabetes, suggesting that the therapeutic utility of this drug encompasses metabolic as well as physical nerve injury. Within the framework of this clinical trial, this study will utilize clinical, neurological, behavioral, electrophysiological and histological assessments of cats with spontaneously occurring diabetes mellitus to evaluate the therapeutic efficacy of Prosaptide^(TM) TX14(A) at reversing established neurological complications in these animals. Successful completion of this double-blind, placebo-controlled clinical trial would benefit both companion animals and humans with the debilitating neuropathy that occurs in diabetes mellitus.

Study Design:
Prospective, Placebo-controlled, Randomized, Double-blinded

Sample Size:
60 diabetic cats

Inclusion criteria:
Patients need to meet several inclusion criteria:

1. Confirmation of diabetes mellitus
2. Clinical signs of diabetic neuropathy
3. Ambulatory without assistance
4. No evidence of peripheral neuropathy of another etiology
5. Not hyperthyroid.

Exclusion Criteria:

1. Hyperthyroidism
2. Peripheral neuropathy from another cause

Study Endpoints:
Diabetic cats will be treated with the study drug or placebo for a period of 8 months. The study end-point will be the 8 month time-point.

Samples:
Muscle, nerve, and foot pad biopsy specimens will be submitted by the board certified neurologists participating in this study. Clinicians interested in enrolling cats in this study will need to refer candidate cases to neurologists for enrollment in the study. A complete protocol for this study is provided to the neurologists and the referring clinicians if requested.

Participating Neurologists
Dr. David Lipsitz
Veterinary Specialty Hospital of San Diego, San Diego, CA
Dr. Tammy Stevenson
Southern California Veterinary Referral Group, Irvine, CA
Dr. Karen Vernau
University of California, Davis, Davis, CA
Dr. Michael Podell
Animal Emergency & Referral Center, Northbrook, IL
Dr. Andrew Hopkins
North Florida Veterinary Neurology, Orange Park, FL
Dr. Stephanie Kube
VCA South Shore Veterinary Specialists, Weymouth, MA
Dr. Curtis Dewey
Cornell University, Ithaca, NY
Dr. Marc Kent
University of Georgia, Athens, GA
Dr. Anne Katherman
Veterinary Neurology And Neurosurgery, Virginia Beach, VA

Costs/Reimbursements:
Costs of documenting blood work, electrophysiology, and collection of biopsy specimens will be covered up to approximately $2,100 total per cat. This will cover 3 visits. The first visit will include EMG, NCV and biopsies. There will be a 4 month visit with just neurological examination, and final visit at 8 months with repeat biopsy collection.

Full Disclosure information:

• The study is funded by a grant from the Juvenile Diabetes Research Foundation.
• The investigators do / do not have any conflict of interest.
• The study will be published if results are negative.
• The study will be reported on VIN.
• TThe authors will acknowledge VIN if the study is published and VIN has contributed significantly to recruitment.