UPDATE: Largest Interventional Canine Clinical Trial Begins Next Stage

UPDATE (June 11) — In January, Arizona State University received a multi-year, $6.4 million grant to support a clinical trial assessing the effectiveness of a specific vaccine in preventing any type of canine cancer. And now, 3 universities are getting ready to start the next stage of work—actually testing the vaccine.

Over the last decade, Stephen Albert Johnston, PhD, director of the ASU Biodesign Center for Innovations in Medicine and CEO of Calviri, Inc., a cancer vaccine company, and his team have worked toward identifying tumor antigens that are common among cancers. Identifying common tumor antigens is one of the key components of his new vaccine, a multi-valent frameshift peptide vaccine.

“No one else has proposed any other way you could possibly make a prophylactic vaccine,” Dr. Johnston said. “So, if we’re the only game in town, and there’s even a 10% chance it might work, we should try it.”

Beginning in July, Colorado State University, the University of Wisconsin-Madison, and the University of California, Davis, plan to inoculate 800 middle-aged dogs with Dr. Johnston’s new vaccine.

Half of the dogs in the trial group will be chosen at random to receive the preventive vaccine and the others will receive a placebo injection. Each dog will receive an annual booster dose and a physical exam and will be tracked over 5 years for signs of any cancer or side effects.

Dr. Johnson believes the investigators will know whether the preventive vaccine is working within a year or 2, and he hopes it will protect against as many as 80% of new tumors.

(January 14) — The largest interventional canine clinical trial ever conducted has recently received the financial backing necessary to move forward.

Arizona State University has been awarded a multi-year, $6.4 million grant to support a clinical trial assessing the effectiveness of a specific vaccine in preventing any type of canine cancer. The money will be provided by the Open Philanthropy Project, a grant-giving organization largely funded by Facebook co-founder Dustin Moskovitz and his wife Cari Tuna. The Open Philanthropy Project is particularly focused on providing grants for scientists whose “high-risk” ideas have been turned down by the government.

The grant was presented to Stephen Albert Johnston, PhD, director of the university’s Biodesign Center for Innovations in Medicine and CEO of Calviri, Inc., a cancer vaccine company. Dr. Johnston’s clinical trial had previously been rejected for funding by the U.S. National Institutes of Health.

This $6.4 million grant will be used to further the work Dr. Johnston and his team have done over the last decade to identify tumor antigens that are common among cancers. Identifying common tumor antigens is one of the key components of the vaccine, called a multi-valent frameshift peptide (FSP) vaccine. Through the trial, researchers hope to prove that vaccinations with FSPs can help the body recognize—and destroy—cancer cells prior to the materialization of tumors.

“Open Philanthropy was the only organization that responded to support our high-risk project, the biggest cancer intervention trial in dogs ever,” Dr. Johnston said.

Luhui Shen, PhD, senior science director of the vaccine project, said the research team has been working for over 10 years developing a vaccine that could potentially prevent cancer. “Our next goal is to test the vaccine in owner-enrolled healthy dogs. We are fairly confident that if the vaccine works in dogs, it could work in people.”

To date, the vaccine has been tested for efficacy in mice and is shown to be safe in dogs.

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• Diagnosing and Treating Cancer

The Clinical Trial

The trial will be supervised by Douglas Thamm, VMD, director of clinical research at the Flint Animal Cancer Center at Colorado State University. Researchers will test the cancer-prevention efficacy of the vaccine in 800 healthy, middle-aged companion dogs.

Dogs in the trial group will be chosen at random to receive either the preventive vaccine or a mock version. Throughout the length of the trial, all the dogs will continue to maintain their normal lives at home and receive biannual exams with a complete clinical pathology workup. Any dogs enrolled in the study who develop cancer—regardless of whether they receive the vaccine or mock version—will be provided with a credit toward medical expenses.

Researchers anticipate that dogs receiving the mock vaccine will develop cancer at normal rates, but hope to see a decrease in cancer rates among the canines who receive the actual vaccine.

Future Trials

Cancer is one of the leading causes of death in companion dogs, and the cancers developed in canines are very similar to those diagnosed in humans. Similarly, the immune systems of dogs respond to tumors and vaccines much like humans.

According to grant details made public by the Open Philanthropy Project, the funding will be split into an initial payment to support trial set-up and recruitment. If successful, additional payments will be released to fund all aspects of the trial including examination, vaccination, and follow up over 5 to 7 years. If the vaccine is successful in preventing cancers in canines, researchers expect that the trial will also lead to validating the need for similar human clinical trials.

“If the vaccine works it should be inexpensive enough that everyone in the world could get it,” Dr. Johnston said.