DUSA Pharmaceuticals reports encouraging results in Phase I/II acne clinical trial.

MISSISSAUGA, Ontario--(HealthWire)--Oct. 7, 1996--DUSA Pharmaceuticals Inc. (NASDAQ NMS: DUSA) reported today encouraging results from its Phase I/II dose-ranging clinical trial using topical ALA Photodynamic Therapy (ALA PDT) for the treatment of acne vulgaris.

This study on inflammatory acne was conducted by Dr. Luciann Hruza of Washington University School of Medicine in St. Louis. The initial phase consisted of ALA application without exposure to light, in order to determine optimal drug concentrations, and the preferred time before light treatment.

The treatment portion of the study was then carried out on 80 acne lesions (including controls) in 10 patients. A single light treatment was administered at six different doses of light, using DUSA's proprietary non-laser red light source, and two different drug concentrations.

After seven days, significant clearing (80-100% improvement), was seen in up to 75% of the ALA PDT treated areas, compared to none of the 'light alone' control sites, and 29% of the 'ALA alone' control sites. After 21 days, significant clearing had occurred in up to 80% of the ALA PDT sites, compared to 40% of the 'light alone' control sites, and 25% of the 'ALA alone' control sites. The treatments were well tolerated, with no adverse events reported.

Dr. Geoffrey Shulman, DUSA's president and CEO, stated "Although this trial was designed as a proof of principle study, and was not sized for statistical significance, we are encouraged that ALA PDT appears to be a potential new approach in the treatment of acne. The company is now working on a new protocol incorporating multiple treatments, in preparation for a Phase IIa clinical trial expected to start in the new year. Acne is the most common skin condition seen by physicians in the United States, with acne medications accounting for an estimated $400 million per year."

DUSA Pharmaceuticals Inc. is a development stage New Jersey pharmaceutical company engaged primarily in the development of ALA Photodynamic Therapy ("PDT") and Photodiagnosis ("PD") for multiple medical indications. PDT and PD utilize light-activated compounds such as ALA to induce a therapeutic or diagnostic effect. DUSA is a world leader in topically or locally applied PDT and PD.

Expect for historical information, this news release contains certain forward looking statements that involve risk and uncertainties which may cause actual results to differ materially from the statements made. Such factors include, but are not limited to, changing market conditions, clinical trials, results, the establishment of new corporate alliances, the impact of competitive products and pricing, the timely development, FDA approval and market acceptance of the company's products, and other risks detailed from time to time in the company's United States Securities and Exchange Commission (SEC) filings.

CONTACT: DUSA Pharmaceuticals Inc., Mississauga

D. Geoffrey Shulman, MD, FRCPC 

905/677-4554

Fax: [phone]

or

Sunrise Financial Group, New York

Derek Caldwell, 212/421-1616

Fax: [phone]