Independent Study Utilizing Cyclic Levulan PDT Finds 95 Percent Reduction in New Squamous Cell Carcinoma Lesions in Solid Organ Transplant Recipients Over a 2-Year Period

WILMINGTON, Mass., Nov. 10 /PRNewswire/ -- The results of an independent investigator study just published in the online version of Dermatologic Surgery demonstrate that Levulan® Photodynamic Therapy (PDT) may reduce the rate of recurrence of squamous cell carcinomas (SCCs) in solid organ transplant recipients (SOTRs), a population with a high incidence of nonmelanoma skin cancer. This pilot study, which will also appear in the print version of the December issue of Dermatologic Surgery, was conducted by researchers at the University of Minnesota Department of Dermatology and found that the median number of SCCs was reduced by 79 percent at 12 months after cyclic Levulan PDT treatment and by 95 percent at 24 months, when compared to the pre-PDT year measurement date.
 

"These results are another step forward in managing and improving the health of SOTR patients who have a much higher risk than the general population of developing SCCs, a skin cancer that is often times deadly in this patient population," said Andrea Willey, M.D., study investigator, Assistant Clinical Professor of Dermatology at the University of California, Davis and practicing dermatologic surgeon at the Laser & Skin Surgery Center of Northern California and Solano Dermatology Associates.
 

SCC, the second most common nonmelanoma skin cancer, has been associated with higher mortality rates in an at-risk population, like SOTRs. According to medical literature, these patients tend to develop multiple tumors that may be more likely to spread due to suppressed immune systems. For these patients, proactively managing the disease becomes a priority in order to reduce the risk of developing invasive SCCs.
 

"As we have previously stated, we were encouraged enough by the results of this study, which are now published, to have initiated a DUSA sponsored, multi-center study to explore the potential benefits of Levulan PDT in this patient population," said Bob Doman, DUSA's President and Chief Executive Officer. "DUSA is excited to be repeating the protocol used at the University of Minnesota in this pilot study to see whether the results can be duplicated in our Phase II study."
 

About the Independent Study
 

This prospective, open-label pilot study conducted at the University of Minnesota's solid organ transplant clinic assessed a group of 12 men and women who had received kidney and/or heart transplants over the past 5 to 30 years. Areas of skin with a high number of persistent keratotic lesions on the forearms, hands, chest, and lower legs were identified for treatment. All SCCs in the treatment and non-treatment areas were treated using Mohs micrographic surgery during the 12 months before initiation of PDT. New SCCs and SCCs in situ that developed during the course of the study were confirmed histologically and treated with Mohs micrographic surgery. Levulan® Topical Solution was applied to the target skin areas and allowed to incubate. This was followed by blue light irradiation with the BLU-U®, blue light photodynamic therapy illuminator. Levulan PDT was repeated at four to eight week intervals for two years.
 

Pretreatment SCC lesion counts for the 12-month point before enrollment were obtained from patient records. The median reduction in the number of SCC lesions was 79 percent at 12 months after initiation of cyclic PDT treatments and 95 percent at 24 months when compared to the number of lesions at the 12-month pre-treatment date. The reduction in the number of SCC lesions was statistically significant at both the 12 and 24 month time points. Adverse events were mild and transient and included erythema, edema, desquamation and focal crusting. These results suggest that cyclic PDT with topical treatments like Levulan® Kerastick® may reduce the incidence of SCCs in SOTR.
 

About DUSA Pharmaceuticals
 

DUSA Pharmaceuticals, Inc.® is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan® Photodynamic Therapy technology platform, and complementary dermatology products. Levulan® Kerastick® (aminolevulinic acid HCl) for Topical Solution 20% plus blue light illumination using the BLU-U® blue bight photodynamic therapy illuminator is approved for the treatment of minimally to moderately thick actinic keratoses (AKs) (Grade 1 or 2) of the face or scalp. DUSA also markets other dermatology products, including ClindaReach®. DUSA is researching Levulan PDT for the treatment of AKs and the prevention of new non-melanoma skin cancer in chronically immunosuppressed solid organ transplant recipients. DUSA is based in Wilmington, Mass. Please visit our Web site at www.dusapharma.com.
 

About University of Minnesota Department of Dermatology
 

The Clinical Research Division in the Department of Dermatology at the University of Minnesota conducts ongoing studies of novel therapeutic agents. Established to explore new drugs, devices, and therapies, the Clinical Research Division is dedicated to pioneering innovative breakthroughs in the field of dermatology. Housed within the Department of Dermatology, the Clinical Research Division has ample office space and a fully equipped lab dedicated to tissue acquisition, immunohisto chemistry, laser scanning confocal microscopy, and more. Division personnel perform multiple clinical trials concurrently, including current studies looking at new treatments for psoriasis, CTCL, atopic dermatitis and alopecia areata. The department is known for its focus on phase II clinical trials - investigational studies positioned at the cutting-edge of discovery. Clinical research trials are available to the general public.
 

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 reduction in rate of recurrence of SCCs, appearance of the results in print, spread of SCCs in patients with suppressed immune systems. 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, the clinical trial process and results obtained, actions by health regulatory authorities, actions of third parties, and other risks and uncertainties identified in DUSA's Form 10-K for the year ended December 31, 2008.
 

Source: DUSA Pharmaceuticals, Inc.

CONTACT: Investor Relations: Chad Rubin, The Trout Group LLC,
+1-646-378-2947; Media: Dayna Hochstein, Spectrum, +1-202-955-6222 Ext. 2524,
both for DUSA Pharmaceuticals, Inc.
 

Posted: November 2009

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