DUSA collaborating with the National Cancer Institute to evaluate PDT for oral cancer

May 5, 2008, Wilmington, MA--A Phase I clinical trial using DUSA Pharmaceuticals' Levulan product has been launched by the National Cancer Institute (NCI) to study photodynamic therapy (PDT) for the prevention of oral cancer, which may affect more than 30,000 Americans this year.

Chronic mouth lesions, the most common of which is a condition known as oral leukoplakia, are early indicators of oral cancer. There is currently no effective treatment for preventing the progression of oral leukoplakia to cancer. The long-term goal of this project is to examine aminolevulinic acid (ALA) photodynamic (PDT) therapy as a preventive treatment for oral cancer by the selective removal of oral leukoplakia.

Oral leukoplakia is a condition involving the formation of white spots on the surfaces of the mouth and tongue. Previous studies have shown that ALA PDT may be used to identify and treat the condition. ALA, the active ingredient in DUSA's product, Levulan, is a chemical that is produced naturally at low levels in humans. If ALA is given to the body at higher levels, the drug can build up inside of pre-cancerous cells. When a laser light is pointed at a pre-cancerous cell, ALA may increase the effect of the laser causing the cell to die. The purpose of the present trial is to examine the safety and tolerability of orally administered ALA PDT and to determine the optimal dose of light therapy.

"The commencement of this trial is a critical first step towards identifying a novel therapeutic intervention that may prevent the progression of precancerous lesions into oral cancer," said Dr. Stuart J. Wong, Protocol Lead Investigator, Medical College of Wisconsin. "The data obtained from this study will be critical to the design of future trials that can examine the effectiveness of ALA PDT for the treatment of oral leukoplakia and/or prevention of oral cancer." Patient selection has begun at the Medical College of Wisconsin, with the University of Chicago to follow as a second site.

During 2004, DUSA signed a clinical trial agreement with the NCI Division of Cancer Prevention for the clinical development of Levulan PDT for the treatment of oral leukoplakia. The NCI DCP will be responsible for the clinical trial costs, while DUSA will provide Levulan, laser light device(s), and the necessary training for the investigators involved in the studies. In the study, the same dose of ALA will be administered orally to six groups of patients with oral leukoplakia. The oral dose will be followed in three to four hours by laser light treatment, with the first group getting the lowest light dose and increasing the light dose for each new group. Safety evaluations will be performed following treatment of each group. Biopsies of target oral lesions and/or tissue where oral lesions previously existed will be performed at registration and completion to evaluate treatment.

"DUSA is pleased to support the National Cancer Institute in the development and initiation of this pilot clinical protocol, which presents a unique opportunity to use Levulan PDT as a new treatment for oral leukoplakia, a condition for which there is no standard therapy," said Bob Doman, president and CEO of DUSA. "The launch of this trial underscores DUSA's commitment to supporting studies that will examine the potential of Levulan PDT as a preventive cancer treatment across different patient populations."

Researchers anticipate that the study will be completed within 12-24 months and based on results, hope to move forward with a phase II trial. Visit http://clinicaltrials.gov for more information on the trial.

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