Healthcare Industry News: orphan drug designation
News Release - May 11, 2009
DUSA Initiates Clinical Trial of Levulan(R) PDT on High-Risk Solid Organ Transplant RecipientsStudy Will Investigate the Safety and Efficacy of Levulan(R) Photodynamic Therapy for the Treatment of Actinic Keratoses and the Prevention of Skin Cancer Recurrence
WILMINGTON, MA--(Healthcare Sales & Marketing Network)--May 11, 2009 -- DUSA Pharmaceuticals, Inc.® (NasdaqGM:DUSA ) announced today the initiation of a DUSA-sponsored study that will examine the safety and efficacy of multiple broad area photodynamic therapy (PDT) for the treatment of actinic keratoses (AKs) and reduction of new non-melanoma skin cancer (NMSC) in chronically immunosuppressed solid organ transplant recipients (SOTRs) at high risk of developing NMSCs.
"The commencement of this trial is a critical first step towards identifying a novel therapeutic intervention that may prevent the progression of precancerous skin lesions for SOTRs," said Dr. Stuart Marcus, DUSA's Chief Medical Officer. "Current treatment options for these patients, for whom skin cancer is a leading cause of death, often cause discomfort and scarring. We anticipate that this study will establish aminolevulinic acid (ALA) PDT as a well tolerated, alternative treatment with diminished side effects compared to current treatment options for transplant patients with a high risk of AKs and squamous cell carcinoma (SCC)."
The study will examine the effect of multiple courses of Levulan® (DUSA's brand of ALA) plus BLU-U® on the treatment of AKs, as well as the reduction of the incidence of new non-melanoma skin cancers on the scalp or forearms of this patient group over the course of one year.
"This study represents an important first step to address a significant medical need for this patient population," said Bob Doman, DUSA's Chief Executive Officer. "We are excited that multiple treatments with Levulan PDT may provide solid organ transplant recipients at high risk of developing actinic keratoses and squamous cell carcinoma with an effective and well tolerated therapy alternative."
SOTR patients are at a high risk of developing AKs and are also prone to the development of multiple aggressive skin cancers, particularly SCCs, due to their medical immunosuppression. Within 10 years, approximately 60 percent of SOTRs develop pre-malignant skin lesions, such as AKs, and 40 to 50 percent of patients develop NMSC, which accounts for nearly 90 percent of all skin cancers in transplant recipients.(1)
(1) Penn I. Post-transplant malignancy: the role of immunosuppression. Drug Saf. 2000; 23:101-113.
About the Study
The 36-patient multi-center pilot study, at approximately 6 sites, will examine SOTRs with a history of multiple annual SCCs to determine efficacy of treatment with ALA, followed by blue light (10J/cm2) as compared to use of vehicle followed by the same light. The treatment area (scalp or both forearms) must have had > 3 NMSC in the past 12 months, and must include a continuous 25 cm2 target area containing a minimum of 4 AKs, to be eligible for treatment. Study participants will be randomized into two groups -- Group 1 and Group 2 -- and will receive either ALA treatment or vehicle, respectively. Participants in Group 1 will have ALA PDT applied to the scalp or both forearms under occlusive dressing 90 +/- 30 minutes prior to BLU-U treatment for 16 minutes 40 seconds. Group 2 will have vehicle applied to the same areas under the same conditions as detailed for Group 1. Topical treatments to areas outside of the treatment area for AKs will be limited to cryotherapy and curettage with or without desiccation only.
Actinic keratoses (AKs) are rough-textured, dry, scaly patches on the skin caused by excessive exposure to ultraviolet light, such as sunlight. They occur most frequently on sun exposed areas such as the face, scalp, ears, neck, hands and arms. They form on the outermost layer of skin and they can range in color from skin toned to reddish brown. They can also range in size from as small as a pinhead to larger than a quarter.
About NMSC and SCC
Non-melanoma skin cancer (NMSC) NMSCs account for approximately 96 percent of all diagnosed skin cancers, and can usually be cured with minor surgery. Squamous cell carcinoma (SCC), which is classified as a nonmelanoma skin cancer, is the second most common cancer of the skin, accounting for about 2 out of 10 skin cancers. SCCs most commonly appear on sun-exposed areas of the body such as the face, ear, neck, lip, and back of the hands, however if not treated early on, they can spread to other areas. More than 250,000 new SCCs are diagnosed every year in the United States. SCCs are more aggressive in chronically immunosuppressed patients. Within 10 years of a solid organ transplant, approximately 40 to 50 percent of SOTR patients develop NMSC.
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 and 2 actinic keratoses (AKs) of the face and scalp. DUSA also markets other dermatology products, including ClindaReach®. DUSA is researching Levulan® PDT for the treatment of AKs and the reduction of new non-melanoma skin cancer (NMSC) in chronically immunosuppressed solid organ transplant recipients (SOTRs). DUSA applied for orphan drug designation in 2008 and is awaiting a decision by FDA on this request. In addition, DUSA is supporting research related to oral leukoplakia in collaboration with National Institutes of Health (NIH). DUSA is based in Wilmington, Mass. Please visit our Web site at www.dusapharma.com.
Forward Looking Statements
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 intention to examine a new therapeutic indication, the potential prevention of disease progression, anticipation of results of the study as an effective and well-tolerated treatment, and the currently planned study protocol. 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, actions by health regulatory authorities, the uncertainties regarding clinical research, reliance on third parties, sufficient funding, and other risks and uncertainties identified in DUSA's Form 10-K for the year ended December 31, 2008.
Source: DUSA Pharmaceuticals
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.