Studies to Evaluate Broad Area Application of Levulan® Kerastick® for the Treatment of Actinic Keratoses (AKs) of the Face or Scalp, and of Upper Extremities
Robert F. Doman, President & CEO – 978.909.2216
Richard Christopher, VP Finance & CFO – 978.909.2211
Chad Rubin, Investor Relations Contact, The Trout Group LLC – 646.378.2947
Cory Tromblee, Media Contact, MacDougall Biomedical Communications – 781.235.3060
WILMINGTON, Mass. – April 24, 2012 — DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), a dermatology company that is developing and marketing its Levulan® Photodynamic Therapy (PDT) platform, announced today that patient enrollment is complete in its Phase 2 clinical trial studying the broad area application with 1, 2 and 3-hour (short) drug incubation for the treatment of actinic keratoses (AKs) of the face or scalp. DUSA also completed enrollment in its pilot Phase 2 clinical trial studying the safety and efficacy of treating AKs on the upper extremities. Both studies are utilizing the Levulan® Kerastick® (aminolevulinic acid HCl) for Topical Solution, 20% with the BLU-U® Blue Light Photodynamic Therapy Illuminator. The FDA-approved labeling for Levulan® Kerastick® requires application of Levulan® to individual AK lesions, but in these clinical trials a broad area application method is being utilized, where Levulan® is applied to an entire skin region.
The face/scalp exploratory study recruited patients at 13 clinical trial sites across the United States, enrolling a total of 233 patients. This vehicle-controlled study is designed to evaluate the effect of incubation time, and spot versus broad area application method, on the safety and efficacy of Levulan® PDT in the treatment of multiple AKs of the face or scalp and to investigate the potential for reduction of the occurrence of AKs in the treatment areas.
The extremities pilot study recruited patients at 3 clinical trial sites across the United States, enrolling a total of 71 patients. This vehicle-controlled study is designed to examine and compare the safety and efficacy of the broad area application method of Levulan® PDT for the treatment of AKs on the upper extremities and to evaluate the effect of occlusion on the safety and efficacy of Levulan® PDT, using blue light after a 3-hour incubation period.
“We are looking forward to the fourth quarter of 2012, when we anticipate reporting the preliminary top-line statistical analysis of the trial results”, stated Robert Doman, President and CEO of DUSA. “We are also excited because the data from these clinical studies could provide us with significant further insight into the potential clinical benefits of Levulan® PDT.”
About Actinic Keratoses (AKs)
Often called “sun spots,” AKs are rough-textured, dry, scaly patches on the skin that are caused by excessive exposure to ultraviolet light such as sunlight and have the potential to progress to squamous cell carcinoma (SCC)—the second most common skin cancer. They occur most often on the face, scalp and ears. They can range in color from skin toned to reddish brown. They can be as small as a pinhead or larger than a quarter. While most AKs remain benign, approximately 10 percent develop into SCC within an average of two years. Since there is no way to know ahead of time which ones will become cancerous, it is very important to seek a dermatologist’s care. Frequent skin examinations are the key to early detection and prevention. It is estimated that up to 58 million people in the United States have AKs.1
DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan® PDT technology platform. Levulan® Kerastick® (aminolevulinic acid HCl) for Topical Solution, 20% plus blue light illumination using DUSA’s BLU-U® Blue Light Photodynamic Therapy Illuminator is currently approved for the treatment of minimally to moderately thick actinic keratoses (AKs) of the face or scalp.
1Lewin Group. Burden of Skin Diseases. 2005.
DUSA is based in Wilmington, Mass. Please visit our website at www.dusapharma.com. Except for historical information, this news release contains certain forward-looking statements that represent our current expectations and beliefs concerning future events, and involve certain known and unknown risk and uncertainties. These forward-looking statements relate to the timing of reporting of trial results, the significance of the results. These forward-looking statements 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, marketing of competitive products, actions by health regulatory authorities, clinical trial risks, expenses and results, changing economic conditions, the status of our patent portfolio, reliance on third parties, and other risks and uncertainties identified in DUSA's Form 10-K for the year ended December 31, 2011.