DUSA Completes Enrollment for Phase IIb Trial of Levulan® Photodynamic Therapy for Moderate to Severe Acne
WILMINGTON, MASSACHUSETTS–( EMWNews – March 31, 2008) – DUSA Pharmaceuticals, Inc.® (NASDAQ GM:DUSA), is pleased to announce today that the acne Phase IIb trial has achieved its goal of 260 participants, thus completing enrollment. The study’s objective is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy (PDT) treatments with Levulan® Kerastick® in combination with BLU-U® brand blue light versus use of the BLU-U alone in patients with moderate to severe facial acne vulgaris. This trial will evaluate the incremental advantage of adding Levulan to DUSA’s already FDA-cleared BLU-U blue light therapy when treating acne.
“Completion of enrollment is an important milestone as DUSA looks to achieve a moderate to severe acne indication for Levulan PDT. Once the initial results are available, which we expect this fall, DUSA will decide on the next steps needed to develop this indication for potential FDA approval,” said Bob Doman, President and CEO of DUSA. “DUSA continues to support trials in order to advance therapies that offer dermatologists innovative, effective treatments for their acne patients.”
This DUSA-sponsored randomized, controlled, investigator blinded study is being conducted at 14 sites across the country. Levulan in topical solution or the solution without Levulan will be applied to the full face of participants approximately 45 plus minus 15 minutes prior to treatment with 5 or 10 J/cm2 of BLU-U light. Patients will receive treatment once every three weeks with a maximum of four treatments. The primary efficacy assessment will occur three weeks after the last treatment.
According to the American Academy of Dermatology, acne is the most common skin disorder in the U.S., affecting 40 to 50 million Americans. There are many types of acne, the most common of which is called acne vulgaris. Just beneath the surface of the skin lie hundreds of tiny glands called sebaceous glands. Their function is to collect and excrete the oily substance called sebum, to keep the skin healthy. However, the tiny pathway for the sebum to escape often becomes clogged, and a bacterium called P. acnes grows inside. In a short time, the area swells up and forms a lesion on the skin. At certain times of life, this process becomes very active, troublesome and hard to control.
About Levulan® Photodynamic Therapy (PDT)
Levulan PDT is a unique 2-step treatment for Grade 1 or 2 actinic keratoses (AKs that have not yet become enlarged and thick) of the face or scalp. In the U.S., the therapy consists of treatment with Levulan® Kerastick® Topical Solution, 20% followed by illumination with DUSA’s BLU-U® brand light source.
About the BLU-U®
The BLU-U® Blue Light Photodynamic Therapy Illuminator offers effective, non-invasive and pain-free blue light treatment for moderate inflammatory acne. Narrow band blue light causes a photodynamic effect within the pilosebaceous gland that kills P. acnes, the bacteria primarily responsible for acne. BLU-U treatments can be a primary treatment, an alternative to pharmaceuticals and topicals, or an addition to skin care programs.
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 ClindaReachTM and Nicomide®. DUSA is also researching additional indications for internal uses of Levulan PDT. DUSA is based in Wilmington, Mass. Please visit the company’s website at www.dusapharma.com for more information.
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 evaluation of advantages of Levulan PDT, expectations of the timing of results, decisions about next steps in development, and parameters of the protocol. 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, availability of funding, clinical trial results, actions of competitors, and other risks and uncertainties identified in DUSA’s Form 10-K for the year ended December 31, 2007.
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