Clinical Trials

Clinical and Safety Evaluation of Multiple Intravenous Administrations of Immunocidin® in Cats and Dogs with Malignancies

Jeannette Kelly1, Megan Padget1, Chad Johannes2, Aleksandar Masic3

Veterinary Cancer Care, Santa Fe, New Mexico, USA

Iowa State University, Ames, Iowa, USA

NovaVive Inc, Belleville, Ontario, Canada

Mycobacterium Cell Wall Fraction (MCWF) is a non-specific immunomodulator derived from a non-pathogenic mycobacterium, Mycobacterium phlei currently licensed in Canada and USA for treatment of mixed mammary tumors and mammary adenocarcinoma in dogs marketed as Immunocidin®. MCWF has been used for treatment of other malignancies such as osteosarcoma, transitional cell carcinoma, soft tissue sarcoma, hemangiosarcoma and transitional venereal tumors in dogs. MCWF is considered a bifunctional anticancer agent that induces apoptosis in cancer cells and stimulates cytokine and chemokine synthesis by immune system cells.

The purpose of the present research was to assess clinical and safety profile of Immunocidin® following multiple intravenous administrations in cats and dogs with various malignancies. In addition, we explored Immunocidin® immunomodulatory potential and effectiveness as an adjunct treatment to oncology standard of care for treatment of various neoplasias in dogs and cats.

Prior to the start of the study, the experimental protocol was reviewed and approved by institutional animal care and use committee. The study was single site-specific, non-blinded, clinical pilot-study conducted at oncology referral clinic Veterinary Cancer Care, Santa Fe, New Mexico, USA. Inclusion criteria for the study were: life expectancy of a minimum of 6 weeks, confirmed neoplasia by histology or cytology and no concurrent radiation or steroid therapy. Total of 35 patients were enrolled in the study. Patients enrolled in the study had the following tumor types: mast cell tumor (1 canine), thyroid carcinoma (1 canine), high grade soft tissue sarcoma (3 canines), lymphoma (8 canines/ 2 felines), fibrosarcoma (1 canine), osteosarcoma (2 canines), injection site sarcoma (1 feline), oral melanoma (2 canines), anal gland adenocarcinoma ( 2 canines), transitional cell carcinoma (1 canine), hemangiosarcoma (4 canines) , mammary adenocarcinoma (3 canines), histiocytic sarcoma (2 canines), pulmonary carcinoma (1 canine), multiple myeloma (1 canine) and pheochromocytoma (1 canine). Immunocicin® (MCWF emulsion) was supplied by NovaVive INC., Canada.

Concurrent use of Chemotherapy and Immunocidin® for treatment of canine Lymphoma and Osteosarcoma

Immunocidin® is a non-specific immunotherapy approved for the treatment of canine mammary tumors. Medical records of dogs who received Immunocidin between 2016 and March 2019 at Veterinary Cancer Care P.C., Santa Fe, NM were reviewed for this retrospective study. Our aim was to report the effect of concurrent chemotherapy and Immunocidin in cancer-bearing dogs. Twelve dogs met the inclusion criteria: confirmed Lymphoma or Osteosarcoma via cytology or histopathology; chemotherapy treatment; two or more Immunocidin treatments; and a minimum of three months of follow-up after first Immunocidin treatment. Chemotherapy agents, route/number of Immunocidin treatments and survival times were reviewed. Lymphoma patients received Doxorubicin and/or Vincristine, alone or combined with other chemotherapeutic agents; Osteosarcoma patients received Carboplatin or Carboplatin-Cisplatin-based chemotherapy. Immunocidin was administered intravenously in all dogs, and also intralesionally in two dogs. Adverse events within hours of Immunocidin administration were mild, and primarily consisted of hyperthermia and lethargy. Median survival time for dogs with Lymphoma (n=8) was 234 days (range: 135-984) and Osteosarcoma (n=4) – 291 days (range: 104-455). The median follow-up period from first Immunocidin treatment was 7 months (range: 4-24) for Lymphoma, and 10 months (range: 3-14) for Osteosarcoma. Until the last reviewed follow-up, 6 dogs (50% in each group) were still alive. Immunocidin may have potential as a well-tolerated adjunct to chemotherapy for Lymphoma and Osteosarcoma. Prospective trials are warranted to evaluate the potential immunologic effects of systemic Immunocidin administration in dogs as well as standardized protocols combining chemotherapy and Immunocidin in the treatment of Lymphoma and Osteosarcoma.

Intralesional Chemotherapy Clinical Trial

Intralesional chemotherapy is the administration of cancer fighting drugs directly into the tumor, tumor site, or adjacent tissues. The goal is to provide local tumor control by achieving high local chemotherapeutic drug concentrations. Because the chemotherapy is not given into a vein, the side effects tend to be few. The advantages are ease of administration, low risk of side effects, low cost, and the option for subsequent treatments in the event of a tumor recurrence.

For additional information regarding the use of intralesional chemotherapy to treat acanthomatous ameloblastoma in dogs please see our publication:

Acanthomatous ameloblastoma in dogs treated with intralesional bleomycin.

Veterinary and Comparative Oncology, Volume 8, Issue 2, pages 81–86, June 2010

Intralesional 5-Fluorouracil treatment for Soft Tissue Sarcoma in Dogs

Soft tissue sarcomas (STS) are a group of similarly behaving cancers that account for 15% of the tumors of skin and subcutaneous tissue in dogs. The most effective treatment for STS is wide surgical excision (removing the tumor and several centimeters of the surrounding tissue) followed by radiation. Radiation can be logistically challenging and financially challenging. 5-Florouracil (5-FU) is a commonly used systemic chemotherapy drug that has shown promise as a local (intralesional) treatment alternative to radiation. At Veterinary Cancer Care we are concluding a six-year preliminary trial of intralesional 5-FU post-surgery in dogs with STS. If proven effective, this would provide a lower cost alternative to radiation therapy available to all veterinarians. We hope to publish results in the near future. While we compile data for publication we are continuing to offer this treatment.

For currently published results using 5-FU in dogs with STS see the following publication:

Postsurgical intra-incisional 5-Fluorouracil in dogs with incompletely resected, extremity malignant spindle cell tumours: A Pilot Study.
Veterinary and Comparative Oncology, Volume 5, Issue 4, pages 239–249, December 2007