ethical and commercial: First of all, testing a drug and getting it approved can be a much quicker process on the veterinary side than it is on the human side, offering companies the potential for a more immediate market opportunity.
More importantly, says Szalay, biotech companies don’t want to create the perception that they’re using people’s pets merely as tools for advancing human medicine. “We’ve come to the realization that animals also need our help,” he says.
Ogilvie began recruiting dogs for a trial of Genelux’s veterinary drug, called V-VET1, in late June. Both V-VET1 and its human counterpart, GL-ONC1, are modified versions of vaccinia, the virus that causes cowpox and is the basis of the smallpox vaccine in humans. Genelux modified the virus to boost its therapeutic ability, Szalay says, and to imbue it with targeting and diagnostic capabilities. V-VET1 and GL-ONC1 were constructed to be able to locate, burrow into, and then destroy tumor cells while leaving healthy tissues intact. The drugs also have light-emitting properties that allow oncologists to track their activity in the body using imaging technologies.
Genelux scientific advisory board member Yumon Fong, chief of gastric and mixed tumor service at Memorial Sloan-Kettering Cancer Center in New York, says the idea of using viruses to kill cancer cells—a field of research known as oncolytic virology—has been around for several decades. But only recently has genetic engineering advanced to the point where viruses can be modified to be made safe and to carry extra tumor-killing payloads. And because vaccinia doesn’t normally affect humans (or dogs for that matter), it may score extra points on the safety front. “Vaccinia as a smallpox vaccine has been given to millions of people in the western world,” he says. “Therefore to talk to regulatory agencies about it is reasonably straightforward.”
The initial Genelux dog trial will enroll 25 canines with a variety of tumors, Ogilvie says. Chance, for example, has a relatively common tumor type called an adenocarcinoma under his tail.
Ogilvie’s clinic will use several different imaging scans and tissue tests to determine exactly what the drug is doing in the dogs’ bodies. Ogilvie will share his insights with human oncologists at the Moores Cancer Center at the University of California San Diego, where he serves on the faculty. Genelux CEO Szalay is also on the faculty at Moores, and one of the early-stage trials of the human version of the drug is taking place there, he says.
One of the advantages for dog owners who participate in comparative oncology trials is that their pets’ care is usually subsidized by the drug company, the veterinary clinic, or some combination of the two. Chance’s owner, Ken Willcut, says the only alternative for him would have been to spend more than $2,000 to have his dog’s tumor surgically removed. “For a guy just trying to get by, that’s not an option for me,” says Willcut, who adds that he was concerned about subjecting his 14-year-old dog to major surgery. “He’s got so much life in him. He’s still bouncing off the walls like terriers do. I just wanted to be able to maintain his quality of life.”
More Realistic Than Mice
Natick, MA-based Karyopharm is testing its cancer-fighting technology in both dogs and humans, and like Genelux, it’s examining two separate molecules that act on the same target. Karyopharm is developing compounds that inhibit a protein called CRM1, which prevents the body’s tumor-fighting mechanisms from working properly inside cells.
Karyopharm CEO Michael Kauffman says the dog trials have been particularly valuable for understanding the side effects that can result from blocking CRM1. “From a tolerability standpoint, knowing what this drug does in dogs is immeasurably beneficial for humans,” Kauffman says. That’s because dogs are part of families, he says, and family members can play an important role in
