The Power of Prevention, Part 2: Promising Patch
Approximately 300,000 Americans annually develop precancerous lesions in the mouth, and about 30 percent of these lesions progress to oral cancer.
The lesions are often surgically removed, but they tend to recur with unfavorable outcomes. The American Cancer Society reports that an estimated 8,400 deaths from oral cancer are expected in 2014.
But investigators at Ohio State’s Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute (OSUCCC – James) hope soon to begin clinical testing of an adhesive medicated patch that releases an anticancer drug called fenretinide directly into precancerous oral lesions to help prevent malignancy. The patch is designed to hold the medication in place so that none of it spreads to the rest of the body, diminishing potential side effects.
Principal investigator (PI) Susan Mallery, DDS, PhD, a professor in the College of Dentistry at Ohio State and a member of the OSUCCC – James, says the team has tested the medicated patch in simulated saliva and in laboratory models. In both scenarios, doses of the drug comparable to levels needed for effective therapy in humans were achieved, and none of the drug escaped into surrounding healthy tissue.
“Before that study,” Mallery says, “scientists had failed to achieve a therapeutic dose of fenretinide because of drug toxicity and rapid loss of the drug from the body. But this medicated patch, with its sound adherence and strong backing, is so secure that that the drug remains in the lesion area.”
Mallery says the patch – designed in the lab of Steven Schwendeman, PhD, a pharmaceutical chemist at the University of Michigan and a collaborator with Mallery’s lab team – has three layers: a disk saturated with fenretinide and other substances that make it more soluble in saliva; an adhesive ring to hold the disk in place; and a backing to hold in the medication.
Mallery’s team – which also includes co-PIs Peter Larsen, DDS, professor of Oral and Maxillofacial Surgery at Ohio State, and Gary Stoner, PhD, emeritus professor of Medical Oncology at Ohio State – is working with Ohio State’s Drug Development Institute and with the university’s Technology Commercialization Office to negotiate with a pharmaceutical firm for a human clinical trial that would involve patients with precancerous oral lesions who are eligible to wear the patch.
In that study, Mallery says, the team would “evaluate tissues before and after treatment for microscopic diagnosis, size and clinical appearance of the lesion.” They would also check to see whether the treated lesions show any molecular signs of progressing toward oral cancer.
Mallery says this work “has the potential to change the treatment model for these lesions."
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