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
