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.
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.
