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Susan Mallery, DDS, PhD

Award Name CCTS Dentistry Pilot
Award Date 04/14/2009

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Preventive Topical Gel for Premalignant Oral Lesions

The Ohio State University College of Dentistry, in collaboration with the Center for Clinical and Translational Science (CCTS), has awarded Susan Mallery, PhD and her co-Investigators, Drs. Peter Larsen, Gary Stoner and Zhongfa Liu, with funding for a project aimed at refining a chemopreventive formulation of a berry-based topical gel on premalignant oral lesions.

Distinct features of this new formulation include compound delivery from a mucoadhesive patch to locally deliver an augmented chemopreventive formulation that includes the synthetic vitamin A derivative fenretinide, and an anthocyanin enriched extract from freeze dried black raspberries.

Mallery, a professor in oral pathology, followed up on Larsen’s lead regarding the use of a patch versus a gel as a method of applying cancer-prohibiting substances in the mouth. In a previous berry gel based clinical study conducted by Mallery, Larsen and Stoner, 30 percent of the population responded in a very positive fashion, including patients designated as “high risk” due to multiple lesion recurrences.

“We were left wondering, ‘Why are [the patients] responding so well?’” said Mallery. “Comparing these data to our subsequent pharmacokinetic study which showed large, patient-related variations in gel uptake, we decided that if we found a way to control delivery and dose of the chemopreventive compounds, we would increase treatment efficacy.”

A Pharmaceutical chemist, Dr. Steven Schwendemen at the University of Michigan, has lent a hand to the chemopreventive patch project. The enhanced formulation of fenretinide and an anthocyanin-enriched freeze-dried black raspberry extract will be delivered from bioadhesive patches which will be designed by Dr. Schwendeman’s lab.

“We will be conducting the proof of the principal pharmaceutical studies in rabbits due to a variety of features including cost, accessibility to ear veins, and abundant gingival tissue”, said Larsen. “By switching to patches, we are hoping to get better results than with the gel. Previous studies conducted by other groups have relied exclusively on systemic (pill form) administration, and were unable to deliver sufficient fenretinide to the oral cavity without inducing toxicities.”

These preclinical rabbit pharmacokinetic studies will generate critical proof of concept data, answering whether the bioadhesive patches effectively deliver therapeutically relevant doses of the chemopreventives to the oral cavity and whether they will serve as the foundation for a future human clinical trial grant application.

As the interest for participation in oral cancer chemoprevention trials remains high among patients with precancerous oral lesions in the Central Ohio area, these OSU investigators are optimistic regarding future clinical prospects.

By Amy Hoover, June 2, 2009

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