The Power of Prevention, Part 2: Promising Patchjamesline.com /the-power-of-prevention-part-2-promising-patch/

April 29, 2014 9:42 am

Approximately 300,000 Americans annually develop precancerous lesions in the mouth, and about 30percent of these lesions progress to oral cancer.

The lesions are often surgically removed, but they tend to recur with unfavorable outcomes. The AmericanCancer 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 SoloveResearch Institute (OSUCCC – James) hope soon to begin clinical testing of an adhesive medicated patchthat releases an anticancer drug called fenretinide directly into precancerous oral lesions to help preventmalignancy. The patch is designed to hold the medication in place so that none of it spreads to the rest ofthe body, diminishing potential side effects.

Principal investigator (PI) Susan Mallery, DDS, PhD, a professor in the College of Dentistry at Ohio Stateand a member of the OSUCCC – James, says the team has tested the medicated patch in simulatedsaliva and in laboratory models. In both scenarios, doses of the drug comparable to levels needed foreffective 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 fenretinidebecause of drug toxicity and rapid loss of the drug from the body. But this medicated patch, with its soundadherence 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 atthe University of Michigan and a collaborator with Mallery’s lab team – has three layers: a disk saturatedwith fenretinide and other substances that make it more soluble in saliva; an adhesive ring to hold the diskin place; and a backing to hold in the medication.

Mallery’s team – which also includes co-PIs Peter Larsen, DDS, professor of Oral and MaxillofacialSurgery at Ohio State, and Gary Stoner, PhD, emeritus professor of Medical Oncology at Ohio State – isworking with Ohio State’s Drug Development Institute and with the university’s TechnologyCommercialization Office to negotiate with a pharmaceutical firm for a human clinical trial that wouldinvolve 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 microscopicdiagnosis, size and clinical appearance of the lesion.” They would also check to see whether the treatedlesions show any molecular signs of progressing toward oral cancer.

Mallery says this work “has the potential to change the treatment model for these lesions.”