Comparative Neuromuscular Laboratory

NEUROMUSCULAR CASE OF THE MONTH - JUNE 2002

A randomized, placebo controlled, double-blind, multicenter canine axonal degeneration clinical trial with Prosaptide™ TX14(A)

Background
No effective therapy exists for canine idiopathic peripheral neuropathy with chronic axonal degeneration. The Myelos Corporation, a wholly owned subsidiary of BioTechnology General Corporation, is sponsoring a randomized, placebo-controlled, double-blind, multi-center clinical trial to test a new experimental drug, Prosaptide™ TX14(A), for therapeutic efficacy in this debilitating nerve disease.

Rat Peripheral Neuropathy Studies
Prosaptide™ has an excellent safety profile to date and has shown demonstrable efficacy in the treatment of diabetic peripheral neuropathy in rats. The drug attenuated and reversed nerve conduction velocity deficits, prevented loss of sensation and reduced neuropathic pain in this animal model [1-3].

Pilot Study in Canine Axonal Degeneration
Additionally, a small, open-label, pilot Prosaptide™ study for canine idiopathic peripheral neuropathy with chronic axonal degeneration yielded encouraging results. Nine dogs were enrolled for six months of thrice weekly dosing. Briefly, the results were as follows:

2 dogs were dropped from the study. One died of unrelated causes and one dog owner was non-compliant.
6 of the 7 remaining dogs were still ambulatory at the end of 6 months dosing showing no signs of clinical worsening.
- 5 dogs showed clinical improvement with no degradation in neurological exams, nerve conduction velocities (NCVs) or nerve biopsies.
- 3 dogs were clinically improved and showed encouraging neurological exams post-trial.
- 2 dogs showed improved biopsies and/or improved sensory NCVs post-trial.
- One dog showed evidence of nerve regeneration post-trial.

Ongoing Canine Axonal Degeneration Trial
We were sufficiently encouraged by these preliminary results to initiate a more comprehensive, 18 month Prosaptideä trial in the same indication. Dogs are currently being screened and enrolled for this new study at nine veterinary centers across the USA. For further information please contact one of these sites or the corporate sponsor listed below.

Contacts for Enrollment in the Myelos Prosaptide Trial for Canine Axonal Degeneration:

Dr. Alan Potthoff Animal Neurological Center 352 Warren Ave. Portland, ME 04103 Phone: (207) 878-3122 Email: anc@maine.rr.com	Dr. Scott Plummer Veterinary Neurosurgical Center 4202 E. Raymond Street Phoenix, AZ 85040 Phone: (602) 437-1488 Email: sbplummer@aol.com	Dr. Don Levesque Veterinary Neurosurgical Center 4445 N. Rainbow Blvd. Las Vegas, NV 89108 Phone: (702)655-1216 Email: mail@vetneuro.com
Dr. Marc Kent 501 DW Brooks Drive Veterinary Teaching Hospital University of Georgia Athens, GA 30602 Phone: (706)542-9384 Fax: (706)542-6460 Email: uganeuro@vet.uga.edu	Dr. Joan Coates University of Missouri Veterinary Teaching Hospital Columbia, MO 65211 Phone: (573) 882-7821 Email: coatesJ@missouri.edu	Dr. Michael Podell Animal Emergency & Critical Care Center 1810 Skokie Blvd. Northbrook, IL 60062 Phone: (847) 564-5775 Fax: (847) 564-5899 Email: mpodell@attbi.com
Dr. Robert Kroll Northwest Veterinary Specialists 16756 SE 82nd Drive Clackamas, OR 97015 Phone: (503) 557-8672 Email: RAKNeuro@msn.com	Dr. David Lipsitz Veterinary Specialty Hospital of San Diego P.O. Box 9727 Rancho Santa Fe, CA 92067 Phone: (858) 756-0790 Email: dlipsitz@ucdavis.edu	Dr. Paul Cuddon Veterinary Specialists of N. Colorado 201 W. 67th Ct Loveland, CO 80538 Phone: (970) 278-0668 Email: Rhino10234@aol.com
Ms. Phuong Chau Myelos Corporation 4940 Carroll Canyon Road, Suite M San Diego, CA 92121 Phone: (858) 777-5900 Email: chau@myelos.com	Dr. Andrew Hopkins North Florida Neurology 280 Corporate Way Orange Park, FL 32073 Phone: (904) 269-7070 Email: nfneuron@aol.com	Dr. Natasha Olby North Carolina State Univ College of Veterinary Medicine Raleigh, NC 27606 Phone: (919) 513-6476 Email: Natasha_olby@ncsu.edu