May 01, 2008 06:30 ET

Phase I Clinical Trial of Photodynamic Therapy (PDT) Underway for Potential New Treatment of Oral Precancerous Lesions

DUSA Pharmaceuticals, Inc.® collaborates with the National Cancer Institute to evaluate Levulan® (aminolevulinic acid, ALA) PDT as treatment for oral leukoplakia

WILMINGTON, MASSACHUSETTS--(Marketwire - May 1, 2008) - A Phase I clinical trial, using a DUSA Pharmaceuticals, Inc. (NASDAQ GM:DUSA) product, has been launched by the National Cancer Institute (NCI) to study an entirely new approach for the prevention of oral cancer, which may affect more than 30,000 Americans this year.(1) 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 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.(2)(3)(4) 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. This is called photodynamic therapy (PDT). 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.

About the Study

During 2004, DUSA signed a clinical trial agreement with the National Cancer Institute (NCI) Division of Cancer Prevention (DCP), for the clinical development of Levulan® photodynamic therapy (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 (PDT), 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.

About DUSA Pharmaceuticals

DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan® Photodynamic Therapy (PDT) technology platform, and complementary dermatology products. Levulan PDT is currently approved for the treatment of Grade 1 or 2 actinic keratoses of the face or scalp, and is being studied for the treatment of acne. DUSA's other dermatology products include ClindaReach™ and Nicomide®. DUSA is also researching additional indications for internal uses of Levulan PDT including oral leukoplakia as described above. DUSA is based in Wilmington, Mass. Please visit the company's website at www.dusapharma.com for more information.

About Medical College of Wisconsin

The Medical College of Wisconsin in Milwaukee, www.mcw.edu, is a private, freestanding academic institution dedicated to leadership and excellence in advancing the prevention, diagnosis and treatment of disease and injury through education, discovery, patient care and community engagement. A major national research center and academic medical center, its faculty physicians and scientists direct or collaborate on more than 3,000 research studies, publish over 1,400 peer-reviewed scientific papers, and provide care in virtually every specialty of medicine to approximately 297,000 patients annually.

About The National Cancer Institute

The National Cancer Institute (NCI) is a component of the National Institutes of Health (NIH), one of eight agencies that compose the Public Health Service (PHS) in the Department of Health and Human Services (DHHS). The NCI, established under the National Cancer Institute Act of 1937, is the Federal Government's principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. The NCI coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

Forward Looking Statements

Except for historical information, this news release contains certain forward-looking statements that involve known and unknown risk and uncertainties. These forward-looking statements relate to the effect of ALA in combination with the laser, the consequences of the therapeutic intervention, the impact of the results on the design of future trials, the parties' respective financial responsibilities, the anticipated dose and protocol parameters, DUSA's commitment to studies, and the anticipated completion date of the trial. These risks and uncertainties are further qualified by important factors that could cause actual results to differ materially from future results, performance or achievements expressed or implied by those in the forward-looking statements made in this release. These factors include, without limitation, actions by health regulatory authorities, changing market and regulatory conditions, the maintenance of our patent portfolio, dependence on third-party vendors and manufacturers, governmental funding, clinical trial results, and other risks and uncertainties identified in DUSA's Form 10-K for the year ended December 31, 2007.

(1) American Cancer Society.: Cancer Facts and Figures 2007. Atlanta, Ga: American Cancer Society, 2007

(2) Tsai, J.C., Chiang, C.P., Chen, H.M., Huang, S.B., Wang, C.W., Lee, M.I., Hsu, Y.C., Chen, C.T. and Tsai, T. Photodynamic therapy of oral dysplasia with topical 5-aminolevulinic acid and light-emitting diode array. Lasers Surg. Med. 34: 18-24, 2004.

(3) Fan, K.F., Hopper, C., Speight, P.M., Buonaccorsi, G., MacRobert, A.J. and Bown, S.G. Photodynamic therapy using 5-aminolevulinic acid for premalignant and malignant lesions of the oral cavity. Cancer, 78: 1374-1383, 1996.

(4) Sieron, A., Adamek, M., Kawczyk-Krupka, A., Mazur, S. and Ilewicz, L. Photodynamic therapy (PDT) using topically applied delta-aminolevulinic acid (ALA) for the treatment of oral leukoplakia. J. Oral. Pathol. Med. 32:330-336, 2003.

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