Matrix III Cisplatin Beads for Equine cutaneous tumors:
RAH currently supports Matrix III Cisplatin Beads under an approved Investigational New Animal Drug Application (INAD 10-829). Having received our MUMS (Minor Use Minor Species is veterinary equivalent of Orphan Drug status in human health) designation we are currently reviewing the FDA-required Target Animal Safety Study (TASS) as the next step in the drug approval process. The nature and requirements of those studies are now under review by Office of New Animal Drug Evaluation (ONADE) and Center for Veterinary Medicine (CVM).
The product has been licensed to the nation’s largest veterinary compounding pharmacy, Wedgewood Pharmacy (www.wedgewoodpharmacy.com), and is sold to veterinarians for general use. In addition, a number of hospitals and clinicians were enrolled in our RAH-sponsored multi-site, field study. These studies provide additional validation of the clinical efficacy and safety under the INAD 10-829 filing. The results are being reviewed by the FDA as a component of our Target Animal Safety Study (TASS).
VetriGel (wound dressing) is considered a device and is, as such, unregulated by the FDA/CVM. In vivo antibiotic release studies show prolonged levels of antibiotic 1.5 cm away from the site of VetriGel implantation. This observation explains the efficacy of VetriGel in treating a wide range of localized infections. Additional in vivo studies currently in progress are scheduled for publication on these VetriGel antibiotic combinations, to expand awareness and proactively drive increased sales revenues for these products to veterinarians. VetriGel has been used extensively in horses and is being used in dogs.
Texas A&M is currently reviewing a proposal from Dr. Shem Oliver, ACVS resident, for evaluation of a biodegradable delivery matrix (VetriGel) for delivery of amikacin sulfate into the tarsocrural joint of horses, under the direction of Joanne Hardy, DVM, PhD, DACVS, DACVEC, Clinical Associate Professor, Texas A&M University. VetriGel has been used experimentally in the management of a variety of localized infective processes in animals. (please see Clinical Trials section)