DUSA Pharmaceuticals Initiates LEVULAN Phase I/II Clinical Trial For Treatment Of Acne.

Health/Medical Writers

WILMINGTON, Mass.--(BW HealthWire)--Nov. 27, 2000

DUSA Pharmaceuticals, Inc. (Nasdaq:DUSA) reported today the initiation of its new Phase I/II clinical trial using the Company's LEVULAN(R) Photodynamic Therapy (PDT) in the treatment of acne vulgaris.

Acne is the most commonly treated skin disease in the United States and Canada, with millions of patient visits per year afflicting primarily teenagers and young adults.

The study will be conducted at two clinical trial sites, involving a minimum of 50 patients with moderate to severe acne vulgaris of the face. The trial is designed to test the safety and effectiveness of varying LEVULAN(R) PDT drug concentrations with red light in the treatment of acne. The goal is to take advantage of LEVULAN(R)'s preferential uptake by sebaceous glands and P acnes, in order to achieve successful clearing of acne lesions, while attaining an acceptable side effect profile.

DUSA is collaborating with Schering AG Germany (NYSE: SHR) and its U.S. subsidiary, Berlex Laboratories, Inc., on the development of this important dermatological indication. Schering AG obtained exclusive worldwide marketing and distribution rights (excluding Canada) for the LEVULAN(R) PDT System for dermatology indications.

Evidence that LEVULAN(R) PDT could be a useful acne therapy comes in part from earlier DUSA studies, as well as a recently published independent investigator study from Massachusetts General Hospital. As reported in the Journal of Investigative Dermatology, this clinical study, involving 22 patients, demonstrated "obvious and significant improvement of acne of the back for at least 10 weeks after a single PDT treatment, and for at least 20 weeks after four treatments" with 20% LEVULAN(R) and red light. This paper, titled "Topical ALA-Photodynamic Therapy for the Treatment of Acne Vulgaris", by W Hongcharu, C R Taylor, Y Chang, D Aghassi, K Suthamjariya, and R Rox Anderson, was published in the August 2000 issue of the Journal of Investigative Dermatology (Volume 115, pages 183-192).

In addition to the significant and extended improvement in acne seen over time after LEVULAN(R) PDT, a significant decrease in sebum (oil gland) output for the entire 20 weeks of the study was also seen in the treated areas. Sebaceous glands were also reduced in size after therapy, and remained smaller for the duration of the 20 weeks of follow-up. Additionally, Propionibacterium acnes, the bacterium associated with acne, appeared to be significantly decreased for at least 20 weeks after LEVULAN(R) PDT. Side effects seen in the study, using the 20% concentration of LEVULAN(R), included pain during light treatment, a transient inflammatory reaction, and hyperpigmentation that completely faded over several weeks. These were similar to the side effects seen in the DUSA study using the same 20% LEVULAN(R) concentration and blue light.

Dr. Stuart Marcus, DUSA's VP, Scientific Affairs, and CSO, stated, "We are excited by the prospects, in this new clinical trial, of demonstrating a significant and prolonged effect of LEVULAN(R) PDT against common inflammatory acne, while we seek to improve the side effect profile of the treatment."

DUSA Pharmaceuticals, Inc. is a biopharmaceutical company engaged primarily in the development of LEVULAN(R) Photodynamic Therapy (PDT) and Photodetection (PD) for multiple medical indications. PDT and PD utilize light-activated compounds such as LEVULAN( to induce a therapeutic or detection effect. DUSA is a world leader in topically or locally applied PDT and PD. The Company is incorporated in New Jersey, with offices in Wilmington, MA, Valhalla, NY, and Toronto, Ontario.

Except for historical information, this news release contains certain forward-looking statements that involve known and unknown risk and uncertainties, which may cause actual results to differ materially from any future results, performance or achievements expressed or implied by the statements made. These forward-looking statements relate to the development and purpose of studying LEVULAN(R) for acne, the expectations of enrollment and of demonstrating efficacy in the study, and the joint development of this indication with Schering AG. Such risks and uncertainties include, but are not limited to, continuing support of the development plan in conjunction with our dermatology partner, results of the clinical study, development of an appropriate commercial light device, the regulatory approval requirements, intellectual property risks, reliance on third-party manufacturers, and other risks identified in DUSA's SEC filings from time to time.