A unique compound that may help chemotherapy work substantially better than in the past was recently patented by a USC/Norris Cancer Center researcher.
Colin P. Spears, an associate professor in the Department of Medicine, received a patent for a preparation of tetrahydrofolate, a molecule that helps the anti-cancer drug 5-flourouracil work many times more effectively than it would otherwise.
People with cancer of the colon, pancreas or rectum could be most helped by the new compound.
Spears worked with Swedish researcher Bengt Gustavsson to conduct trials of the tetrahydrofolate They compared its action to leucovorin, another drug often used to increase the efficiency of 5-flourouracil, or 5-FU.
In addition to working up to one hundred times more effectively than leucovorin, the tetrahydrofolate shows fewer side effects. Patients taking leucovorin can experience several adverse reactions, including dehydration, nausea and vomiting.
“Leucovorin has a lot of negative aspects to it,” said Spears. “The toxicity profile of the tetrahydrofolate is clearly better than leucovorin.”
Now that Spear’s research group has secured patent protection and a bulk supplier for their invention, they hope to begin phase II clinical trials in cancer patients in the coming year.
The patent covers both naturally occurring and synthetic forms of the tetrahydrofolate preparation. Spears and Gustavsson discovered that the unnatural, or synthetic, form of the tetrahydrofolate compound, combined with 5FU, works better than any of the other combinations they tried.
“That was a completely unexpected finding,” said Spears.
Gustavsson had previously designed a unique injection system, called the air-free Protector� syringe, which guarantees that no air comes in contact with the preparation during treatment. The tetrahydrofolate is too sensitive to contact with air to be delivered any other way.
The special syringe had previously been designed by Gustavsson for a different purpose altogether, an “extremely lucky” breakthrough in the chemotherapy research, Spears said. The preparation helps 5FU to inhibit the action of thymidylate synthase, an enzyme necessary for new cell growth. Previous studies have shown that in cancers, as much as ten times the normal amount of the enzyme can be present.
Spears and Gustavsson were awarded a U.S. patent for the chemotherapeutic agent on July 9 of this year and have assigned the patent to USC.