Dusa signs oral pre-cancer agreement

Dusa Pharmaceuticals has signed a second clinical trial agreement with the National Cancer Institute (NCI), Division of Cancer Prevention (DCP).

The new agreement covers the clinical development of Levulan photodynamic therapy (PDT) for the treatment of oral cavity dysplasia. It follows a similar agreement dated September 27, 2004, covering the treatment of high-grade dysplasia (HGD) within Barrett's Esophagus (BE).Levulan is Dusa's brand of aminolevulinic acid, or ALA.

Dusa and the NCI DCP will be working together to prepare an overall clinical development plan for Levulan PDT in oral cavity dysplasia, starting with a Phase I/II study and continuing through Phase III studies if appropriate.

The immediate plan is for the NCI DCP to solicit clinical protocols from its extramural expert clinical investigator consortium, after which time Dusa and the NCI DCP will finalise the clinical trial design. The NCI DCP will use its resources to file its own IND. Dusa will provide Levulan, device(s) and the necessary training for the investigators involved in the studies. Dusa will maintain full ownership of its existing intellectual property and, subject to successful Phase II and III clinical trial results, intends to seek FDA approval in due course.

Independent investigator studies ¹ have reported that ALA may be used to both identify and to remove dysplasia within the oral cavity and larynx. Dusa and the NCI DCP will be carrying out clinical testing of Levulan PDT to determine its potential to provide an entirely new approach to the prevention of oral cavity cancer.

Dr. Ramon Franco, director of the Division of Laryngology at the Massachusetts Eye and Ear Infirmary, uses ALA-PDT to treat his patients with laryngeal keratosis. He said: 'Based on my experience with this experimental therapy to date, I believe that ALA-PDT holds great promise for the treatment of all oral precancers. There is currently no widely accepted treatment for oral precancers and the current standard of care is "watchful waiting" for the development of cancer.'

Dr Stuart Marcus, Dusa's VP scientific affairs and CMO, commented: 'We are very pleased that the NCI DCP is bringing its resources to bear on this collaborative clinical development effort. The treatment of oral cavity dysplasia is an example of a significant unmet medical need. Publications of the results of independent investigator studies in this area have reported positive results for ALA PDT in the treatment of oral cavity pre-cancers, using ALA given by both topical and systemic dosing. The goal of the new Dusa/NCI collaboration is the development of a simple, safe and effective treatment for this precancerous condition.'

Oral Cancer and Dysplasia

Approximately 30,000 Americans will be diagnosed with oral cancer this year, and another 12,500 will be diagnosed with cancer of the larynx, or voice box. Risk factors include tobacco use and alcohol consumption. Some types of pre-malignancy, such as leukoplakia (visible as white patches seen on the lining of the oral cavity and larynx), are relatively common and affect approximately 2.1m Americans. As many as 25% of leukoplakias are dysplastic at the first visit, and dysplasia currently appears to be the best predictor that a lesion will progress to cancer; There is currently no effective treatment for preventing progression of leukoplakia to cancer.