Can clinical trials on household pets help advance research on treatments for human diseases?
A growing number of researchers believe that they can…
At the end of last year, New Haven-based Kolltan Pharmaceuticals conducted a clinical trial in dogs that showed KTN0158 substantially shrank mast cell tumors. Due to the promising effect its drug had on skin cancers in canine participants, Kolltan Pharmaceuticals was able to begin human clinical trials targeting KIT, a gene thats linked to a couple different types of cancer.
“The dog trial had a dramatic impact on our strategy to develop this product for people,” Kolltan Pharmaceuticals president Jerry McMahon said to Science magazine.
New Decisions and New Opportunities
Kolltan Pharmaceutical’s study commenced shortly after an influential industry workshop took place in Washington, D.C.
The meeting, sponsored by the U.S. National Academies of Science, Engineering and Medicine, brought together 200 veterinarians, physicians, pharmaceutical companies and regulators with the goal of making pet clinical trials a bigger part of mainstream drug development.
A major roadblock for future pet clinical trials was removed during this meeting. An FDA representative in attendance confirmed that drugs wouldn’t be prohibited from testing in humans if they caused a problem in pets. This assurance will open the door to more research using household pets– such as the promising KTN0158 study.
The Cost Effectiveness of Pet Clinical Trials
“Drug development is not a sustainable model the way it is now. It’s too much money and too much time,” says Amy LeBlanc, who oversees pet clinical trials at the U.S. National Institutes of Health (NIH).
A typical clinical trial, which moves from rodents to larger lab animals (such as monkeys) and then to humans, is considered cost-ineffective by many experts in our industry.
Not only can it take 16 years and up to $2 billion to bring a new drug to market, but FDA approval rate is quite low. For investigative cancer drugs: a mere 11% tested in mice ever get approved for testing with humans participants.
This is why more researchers are approving of expanding pet clinical trials. There are several reasons why household pets can provide better results than lab mice and rodents:
- Lab animals are highly inbred
- Lab animals are very sterile; their immune systems have to be obliterated
- Pets live in the same environments as humans
- Pets get many of the same diseases humans do without having their immune system modified. In fact, cancer is the leading cause of death for older dogs and cats
- Pets are genetically diverse
- Pets can have a diet that is more similar to humans than lab animals
Chand Khanna, founder of NIH’s Comparative Oncology Program and chief science officer with Ethos Veterinary Health, summed it up well. “When it comes to pet clinical trials, We can ask much more scientifically rigorous questions that are more likely to intersect with human health.”
What’s Being Done to Address the Ethical Concerns?
When it comes to conducting clinical trials with household pets, there are more ethical concerns than when testing lab animals.
However, there are groups like Philadelphia startup The One Health Company working to address these concerns. Theyre using search technology in order to find sick animals who are a match for clinical trials.
Co-founder and chief operating officer of The One Health Company Benjamin Lewis explains that his company scrapes data from clinical trial sites databases to scout pets with naturally occurring diseases. Pet health data is not bound by HIPAA laws, because pets are legally property. This has made it easier for the startup to amass its own database of 450,000 pets.
“Nobody talks about animal testing because its so taboo. We work the same way as a human clinical trial, except we recruit sick pets instead of sick people,” says Lewis.
These trials are both pet- and human-friendly. Pets stay with their families, who collect data via their smartphones. Unlike in-lab animal testing, diseases are never induced and putting a pet to sleep is never an option.
The role of pet clinical trials holds a lot of promise, even if they arent apart of mainstream clinical research just yet. The FDA’s assurances and the KTN0158 study should mean that more groups will be willing to fund these types of studies. Even if the results dont translate directly to human beings, it should translate to better treatments for our pets.
Matthew Breen, a geneticist at North Carolina State University in Raleigh, leaves us with a compelling thought:
“If we save these dogs, it has an impact on every single family that owns a dog. When I get involved in these trials, it’s about helping the family. If we’re helping the human or the dog, is there really any difference?”
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