Study Title: An RC-2 Beta In-Vitro Growth Inhibition Study in Support of the Canine Lymphoma and Canine Mast Cell Tumor Indications Objectives/Purpose of study: The purpose of the In-Vitro Growth Inhibition Cell Line Study is to resolve the DMSO FDA/CVM/ONADE questions regarding the growth inhibitory properties of DMSO, RC-2 Beta (?), and its components and their individual and collective contribution to the efficacy of RC-2 Beta in the treatment of Canine Mast Cell Tumors and Canine Lymphoma, and permit the CVM/ONADE acceptance of the Ogenx Product Development Plan. Experimental Design: Covance Biomarker Center of Excellence has over 100 fully characterized human and mouse cell lines in inventory. These cell lines have been used successfully in many In-Vitro studies characterizing pharmaceutical compounds, as well as biologics and bio-similars, and they have also been used extensively in a wide variety of In-Vivo oncology models. For the RC-2? Growth Inhibition Cell Line Study, Ogenx will provide to Covance two Canine Lymphoma Cell Lines and two Mast Cell Tumor Cell Lines. These cell lines will be propagated in the recommended growth media and tested for pathogens including mycoplasma. Once these cell lines are confirmed to be pathogen free, they will be employed in the RC-2? In-Vitro Growth Inhibition Studies. Study Site: Covance Biomarker Center of Excellence, Greenfield Indiana Justification: Mast Cell Tumors are the most common malignant skin tumor of the dog representing over 20% of the dermal and epidermal masses diagnosed in veterinary medicine. High-grade tumors (Grade II and III) have metastatic rates ranging from 50-90%. Once these tumors spread, the prognosis is poor and most dogs will die of this disease. The median survival time for a dog with a grade III mast cell tumor with aggressive therapy is approximately 1 year, but is reduced to 4-6 months in face of metastasis. New therapeutic approaches, such as RC- 2?, are desperately needed to improve upon current disease outcomes. Lymphoma is the most common malignancy diagnosed in canines representing up to 24% of all neoplasms seen in dogs. This disease is almost inevitably fatal with the median survival time for dogs receiving aggressive combination chemotherapy at 12 months. New therapeutic approaches, such as RC- 2?, are desperately needed to improve upon current disease outcomes.
