NovaVive Inc. Announces its Canine Cancer Development Plan

19 April 2016

Belleville, Ontario – NovaVive Inc., a Canadian immunobiology company, today announced its innovative canine cancer clinical development plan.

The Company’s mycobacterium cell wall fraction (MCWF) technology has been developed into a safe and effective treatment for canine mammary cancer (Immunocidin®) that is now registered for sale in the U.S. and Canada. The Company is targeting canine hemangiosarcoma, chemotherapy-induced neutropenia, and palliation as new indications for proprietary formulations of MCWF.

Study protocols have been developed in conjunction with the following leading U.S. veterinary oncologists:

Philip Bergman, DVM, PhD, DACVIM-Oncology, who is a Medical Oncologist (since 1994) and Director, Clinical Studies for VCA based in Bedford Hills, New York. Dr. Bergman is an adjunct faculty member of Memorial Sloan-Kettering Cancer Center and past President of the Veterinary Cancer Society and ACVIM Board of Regents.

Craig Clifford, DVM, who is a Medical Oncologist (since 2003) and Director of Clinical Studies for Hope Veterinary Specialists in Malvern, PA. Dr. Clifford was responsible for the development of both  the Veterinary Cancer Society’s resident review session and the Northeast Veterinary Co-operative Oncology Group. He serves on several industry Scientific Advisory Boards.

Cancer is the most common cause of death in dogs over the age of 2 years, and 1 in 4 dogs will die of cancer. In the U.S. alone, there are more than 70 million dogs. The Company estimates that more than 1,000,000 U.S. dogs are diagnosed with cancer each year. Of these, approximately 300,000 are euthanized after diagnosis and 700,000 are treated at a clinic, where 45% will receive palliative care and the remainder will receive chemotherapy (alone or in combination with other interventions).

Hemangiosarcoma is an aggressive, malignant tumor of blood vessel cells that usually appears in the skin, soft tissue, spleen (most common site) or liver. Current therapies (surgery and/or chemotherapy) offer limited benefit. The Company believes that a formulation of MCWF may extend survival time and improve quality of life in dogs with this cancer.

Dogs receiving chemotherapy treatment may suffer debilitating side effects, including neutropenia (low white blood cell count). Early studies have demonstrated that an MCWF formulation can alleviate neutropenia.

Dogs with cancer that are nearing the end of their lives can be treated with a formulation of MCWF that has shown a dramatic improvement in quality of life with few side effects. This allows the animal and its human family to better prepare for euthanization.

“Hemangiosarcoma, chemotherapy-induced neutropenia and palliation represent areas of unmet need or areas where existing therapies induce difficult side effects in dogs with cancer,” said Graeme McRae, President of NovaVive Inc. “The first of these studies is expected to commence within the next 6 months. The Company believes that each study will take 18 months or less to complete.

About NovaVive Inc.

NovaVive is a private company founded in July, 2014. The Company acquired an advanced veterinary immunotherapeutic platform based on mycobacterium cell wall fraction (MCWF) with four regulator-approved products. Some of these formulations have demonstrated the capability of reducing the reliance on antibiotics in the treatment of certain diseases of horses and cattle. Other formulations have been developed as an anticancer therapy in dogs and horses. The MCWF technology was formerly part of Bioniche Animal Health.

NovaVive also acquired the global license to mycobacterial cell wall-nucleic acid complex (MCNA) for treating animal cancers. MCNA is an advanced formulation of mycobacterium cell walls and nucleic acids formulated for human applications. MCNA has been advanced through Phase III in the treatment of human bladder cancer by Bioniche Life Sciences (now Telesta Therapeutics).


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

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