"One Disease...One Drug...Across Species!"
The Company has specifically designed its research and development model based on translational research practice. Based on this strategy the Company embraces the 'One Disease, One Drug' philosophy, which focuses our product development first on several animal disease models that closely resemble human models. This development is particularly focused on viral disease, as well as animal cancer indications such as canine malignant melanoma.
PVX (formerly PANAVIRA™) our first investigational product, is a novel peptide derived from natural sources. It is being evaluated for the treatment of viral infections in non-food animals (dogs, cats, horses and birds). Data from pilot studies in non-food animal species suggest that PVX demonstrates antiviral activity across a broad spectrum of virus families. Based on the mechanism of action, PVX has potential for therapeutic use in animals and humans.
There are currently no antiviral drugs approved for use in animals. Nuovo Biologics has established an Investigational New Animal Drug (INAD# 011-949) file for PVX with the FDA Center for Veterinary Medicine. The INAD status allows the company to conduct the clinical studies required to support FDA approval to market PVX in the U.S. for non-food animal use.
MMX is our Company's investigational new drug to treat canine malignant melanoma. Pilot studies with canine subjects exhibiting significant tumor reduction. The Company has received a second INAD (#013-035) for MMX to treat Stage II & III canine oral malignant melanoma and a Minor Use Designation for this same disease indication. This Minor Use Designation allows the Company to pursue a Conditional New Animal Drug Application or CNADA. The Minor Use Designation Approval is published on the FDA/CVM website.
The FDA/CVM has determined that Nuovo Biologics' products as innovative and has granted the company a waiver of sponsor user fees, under the Animal Drug User Fee Act (ADUFA).Milestone - March 09, 2010
While the Company is currently focused on animal drug development, we realize the potential of a large human market. The research that the Company is currently undertaking and supervising has translational applications for human and zoonotic disease models. The Company expects to be well positioned to take advantage of human market opportunities. Our current animal research and development information can be used as background data for New Drug Applications (NDA).