Immunocidin® Demonstrates an Acceptable Safety Profile Following Intravenous Administration in Dogs and Cats with Various Malignancies

18 June 2018

Napanee, Ontario - NovaVive Inc., an animal health immunobiology company, is pleased to report that positive data related to its canine cancer immunotherapy was presented last week at the 2018 American College of Veterinary Internal Medicine (ACVIM) Forum in Seattle, Washington. Dr. Jeannette Kelly, veterinary oncologist with Veterinary Cancer Care (an oncology referral clinic in Santa Fe, New Mexico), presented data from a clinical and safety evaluation of multiple intravenous (IV) administrations of Immunocidin® in dogs and cats with various malignancies.

Immunocidin is approved in the U.S.A. and Canada for the intratumoral treatment of mixed mammary (breast) tumors and mammary adenocarcinoma in dogs. The product is a formulation of Mycobacterium Cell Wall Fraction (MCWF) which contains mycobacterial cell walls complexed with bacterial nucleic acid (DNA and RNA). MCWF has been demonstrated to induce innate immune responses and cell-mediated immunity. It has been shown that the presence of nucleic acids triggers apoptosis (programmed cell death) in cancer cells.

Dr. Kelly, who is a board certified oncologist (DACVIM oncology), tested Immunocidin in a pilot clinical study that enrolled 44 patients (40 dogs and 4 cats). These animals were confirmed to have cancer through histology or cytology examination. Ten of the dogs were diagnosed with lymphoma. Eleven of the animals had measurable pulmonary metastasis (cancer started in another part of the body and spread to the lungs). They were treated with diluted Immunocidin either as a stand alone agent or alongside chemotherapy according to the standard chemotherapy protocols.

A total of 157 Immunocidin treatments were administered, with minimal adverse events observed (5 animals displayed mild lethargy or fever). Those animals with pulmonary metastasis remained stable or showed regression. The average survival time (from diagnosis) of the 23 study animals who are still alive ranges from 1.1 to 39.8 months.

Dr. Kelly concluded that the safety of IV administration of Immunocidin to dogs and cats with cancer is sufficient to warrant further research. She believes that the product may help treat additional cancer types beyond mammary tumors as an adjunct treatment in combination with standard protocols. She plans to conduct additional, controlled clinical studies to demonstrate the efficacy of Immunocidin as conjunctive therapy to standard treatments for hemangiosarcoma, lymphoma, osteosarcoma and soft tissue sarcoma.

“NovaVive is very pleased with the outcome of this pilot clinical trial and the positive feedback from Dr. Kelly,” said Dr. Aleksandar Masic, Vice-President, Research & Development at NovaVive Inc. “The results demonstrated an excellent safety profile in dogs and cats with various malignancies including terminal cases, suggesting that the IV route of administration for Immunocidin is appropriate for use in general and specialty veterinary clinics. Furthermore, there was no negative interaction observed when Immunocidin was given at the same time as chemotherapy, suggesting this is a safe concurrent treatment which could be beneficial in extending survival time and improving the quality of life of animals with cancer.”

About NovaVive Inc.

NovaVive is a private company founded in July, 2014. The Company has an advanced veterinary immunotherapeutic platform based on mycobacterium cell wall fraction (MCWF) technology with 5 regulator-approved products in the U.S. One formulation has been developed as an anticancer therapy in dogs and horses. Other formulations have demonstrated the capability of reducing the reliance on antibiotics in the treatment of bacterial diseases of horses and cattle or effectively treating viral equine respiratory disease. The Company’s development plan is to identify additional livestock and companion animal diseases that may be effectively treated with its immunotherapeutic technology platform. For more information about the Company, please visit www.NovaVive.ca, or contact:

Graeme McRae, President  
Graeme.McRae@NovaVive.ca
Phone: 613-391-3837         

or            

Jennifer Shea, V-P, Investor Relations & Business Development
Jennifer.Shea@NovaVive.ca
Phone: 613-391-2097

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