LEXINGTON, Ky. and KALAMAZOO, Mich., Dec. 13 /PRNewswire/ -- NanoMed Pharmaceuticals, Inc. today announced that, under an Inter-institutional Agreement with The Ohio State University, the University of Kentucky Research Foundation has granted the company an option for an exclusive license to a novel Bioadhesive Berry Gel for the chemoprevention and treatment of oral epithelial dysplasia -- the precancerous lesions that develop into oral squamous cell carcinoma (SCC). Despite focused efforts to improve therapy, five-year survival rates for patients with advanced stage SCC remain discouragingly low. Of the estimated 30,000 newly diagnosed cases of oral cancer in the U.S. each year, only half of those diagnosed will be alive in 5 years. Worldwide the diagnoses of head and neck cancer are much greater, with over 350,000 to 400,000 new cases being found each year.
Faculty researchers at The Ohio State University and the University of Kentucky and UK's Center for Pharmaceutical Science and Technology have been collaborating for more than 18 months on the development of freeze-dried black raspberry gels for oral and topical cancer chemoprevention. Freeze-dried black raspberries have been shown to inhibit the growth of several forms of cancer in preclinical studies, and clinical trial results from an open, Phase I, multiple-dose pilot study in healthy volunteers showed that black raspberry extracts are well tolerated in humans. Based on these results to date, the Bioadhesive Berry Gel will be tested in humans.
Russell J. Mumper, Ph.D., vice chair and associate professor in the University of Kentucky, College of Pharmacy, Department of Pharmaceutical Sciences, who is also associate director of UK's Center for Pharmaceutical Science & Technology and a co-founder of NanoMed Pharmaceuticals, oversaw the production of the Bioadhesive Berry Gel. "The promising results in preclinical studies encouraged us to develop the bioadhesive gel," Mumper said. "This gel allows the delivery of more potent black raspberry extracts and is easily administered to the patient."
Mumper, in collaboration with researchers at The Ohio State University and the James Cancer Hospital and Solove Research Institute, will evaluate the Bioadhesive Berry Gel in 20 patients with oral lesions in a Phase I/Ia study to begin this month. The objective of the study is to investigate the chemotherapeutic efficacy of intraoral application of the Bioadhesive Berry Gel to induce regression, prevent recurrence, and inhibit progression in persons with oral epithelial dysplasia.
"As far as we know, there is no one anywhere else in the world using a bioadhesive gel like we are," said Dr. Susan Mallery, a dentist and pathologist in The Ohio State University College of Dentistry and a member of The OSU Comprehensive Cancer Center who has been collaborating with Dr. Mumper.
NanoMed expects that preliminary Phase I/Ia study data will be available by mid-year 2006.
About NanoMed Pharmaceuticals, Inc.
NanoMed Pharmaceuticals, Inc. is an advanced drug delivery systems company developing therapeutic and diagnostic products to treat or detect disease. The Company's initial focus is cancer therapeutics and diagnostics. NanoMed's core technology is Nanotemplate Engineering(TM), a flexible, rapid and scaleable nanoparticle manufacturing technology for the delivery of small molecules, peptides, proteins, plasmid DNA, and diagnostic agents.
NanoMed Pharmaceuticals, Inc.CONTACT: Stephen Benoit, CEO of NanoMed Pharmaceuticals, Inc.,+1-269-372-6256 or benoit@nanomedpharm.com
Web site: http://www.nanomedpharm.com/
