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Commonly Asked Questions from Veterinarians

Q. What is canine oral melanoma?
A. Canine oral melanoma is an aggressive cancer of dogs, most commonly occurring in the oral cavity, nail bed, footpad and mucocutaneous junctions. It also can occur in a dog’s skin. Melanoma is the most common oral tumor in dogs.1

Q. What treatment options currently exist for the disease?
A. Traditional therapeutic options for canine oral melanoma may include: surgery to remove the tumor; radiation therapy to treat any tumor cells in the surrounding tissues and local lymph nodes; and chemotherapy for any tumor cells that have metastasized. Because oral melanoma has a history of being highly resistant to chemotherapy, researchers have focused on immunotherapy to address metastatic disease.1,2

Q. How does ONCEPT® Canine Melanoma Vaccine, DNA work?
A. This therapeutic vaccine uses DNA expressing the human tyrosinase gene. The tyrosinase encoded by the xenogeneic (different-species) DNA used in this vaccine is homologous to canine tyrosinase and has been shown to stimulate an immune response to canine melanoma cells expressing tyrosinase. The use of DNA from a non-canine species results in tyrosinase that is not considered a self-antigen by the canine immune system, thereby stimulating a good immune response. The human tyrosinase protein is different enough from the canine tyrosinase protein that it will stimulate an immune response. Yet it is similar enough to the canine tyrosinase that the immune response will target canine melanoma cells.1,2

Q. What data prove the efficacy of ONCEPT?
A. Studies of xenogeneic DNA melanoma vaccines led by Philip Bergman, DVM, MS, PhD, Dipl ACVIM Onc., from 2000 to the present have included more than 100 dogs with oral melanoma and have produced promising results. While the effect of DNA vaccines varies from one animal to another, dogs that have participated in vaccine studies have recorded increased survival times.1,2 These studies have been published in VaccineCancer Immunity and Clinical Cancer Research.

Q. What is the indication for using ONCEPT?
A. The vaccine is indicated for the treatment of dogs with stage II or III oral melanoma for which local disease control has been achieved.3

Q. Can other medications and/or treatments be used concurrently?
A. There are no known contraindications for use of this product in dogs with oral melanoma.3

Q. What adverse effects have been documented following use of the vaccine?
A. A transient, low-grade fever may be observed in some dogs.

Q. What is the dosage for ONCEPT Canine Melanoma Vaccine, DNA, and how and where is it administered?
A. The therapeutic vaccine is administered transdermally in four doses biweekly. Dogs should receive a booster dose every six months thereafter. Each 0.4 mL dose is injected in the medial thigh using the Canine Transdermal Device.3

Q. Since this is a vaccine, can it be used as a preventive?
A. Currently, this vaccine has only been approved for use as a therapeutic vaccine in dogs that have oral melanoma. Most experts believe that the incidence of canine oral melanoma is too low to justify a preventive vaccine for all dogs.

Q. Why isn’t ONCEPT available to general practitioners?
A. This is a unique biotherapeutic with a highly specialized mode of action. It is critical to maintain control over the proper use of this vaccine in clinical cases. Veterinarians are encouraged to work with specialists in their area for referrals.

Q. How do I find a cancer specialist to whom I can refer potential patients?
A. If you require assistance to locate a cancer specialist, please visit www.acvim.org and www.vetcancersociety.org.

Q. Where can I get additional information about ONCEPT Canine Melanoma Vaccine, DNA?
A. For additional information about the vaccine, please contact Merial Technical Solutions at
1-888-MERIAL-1, Option 3.