<PAGE> 1
FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 11, 1999
DUSA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
NEW JERSEY 0-19777 22-3103129
(State or other (IRS Employer
jurisdiction of (Commission Identification
incorporation) File Number) Number)
181 UNIVERSITY AVENUE, SUITE 1208
TORONTO, ONTARIO M5H 3M7 CANADA
(Address of principal executive offices, including ZIP code)
(416) 363-5059
(Registrant's telephone number, including area code)
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ITEM 5. OTHER EVENTS.
The Registrant reports positive results from its Phase l/ll
multi-center clinical study using Levulan(R) PDT for hair removal.
Thirty patients were enrolled in this study at 3 clinical trial sites in the
United States. Upper leg (thigh region) areas were treated with topical
Levulan(R) 20% in solution formulation, followed by treatment with red laser
light at 635 nm or broad-bandwidth non-laser red light 4 hours after the
solution was applied. Laser and broadband light was used at a variety of dose
rates and total light doses. Controls used in this study included drug without
light, light with vehicle alone as well as untreated sites. Subjects were
followed for 6 months after a single treatment with Levulan(R) PDT. Both
independent objective human hair counting and computer pattern recognition
methods from standardized photography were used to determine accurate and
objective hair counts.
Efficacy analyses carried out 6 months after the single Levulan(R) PDT treatment
showed the following: For the non-laser light sources, the highest light dose
rate and light dose showed a reduction in hair count from baseline of
approximately 10-15% as compared with that seen in the no treatment control
site. Levulan(R) plus laser light delivered at high doses showed the best
result, a 20-24% reduction as compared with control sites. Mild to moderate
burning and stinging during light exposure was experienced by the majority of
patients using both types of light sources. Hyperpigmentation was also observed
in the majority of patients treated using this protocol, in some cases
persisting throughout the 6 months of follow-up.
Dr. Stuart Marcus, Senior VP and CSO of DUSA stated "We find these results on
hair removal encouraging. This well controlled trial clearly demonstrated a
measurable and meaningful reduction in hair counts. The results show that a
biologically targeted method of hair removal using Levulan(R) and light can
cause significant hair removal following a single treatment, particularly for
actively growing follicles." Dr. Marcus continued "Since as many as 83% of the
hair follicles on the leg are not in an active growth state at any one time, it
was not expected that one treatment would eliminate the majority of hair in that
location. Therefore, the 20-24% hair loss we observed in this early stage trial
may indicate that a high percentage of the actively growing follicles were
destroyed with a single treatment."
"However, substantial research and testing will be required in order to develop
a commercial product. DUSA's future research on hair removal may include
treatment of other body areas with more actively growing hair, multiple
treatments to target hairs growing at different times, use of deep-penetrating
non-laser red light sources, and optimization of drug delivery in order to
minimize hyperpigmentation," Dr. Marcus said. "In summary, this study offers
significant preliminary evidence that Levulan(R) PDT is the first biologically
targeted method for removing human hair and DUSA intends to move forward with
development of this exciting opportunity."
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Except for historical information, this report contains certain forward-looking
statements that involve known and unknown risk and uncertainties, which may
cause actual results to differ materially from any future results, performance
or achievements expressed or implied by the statements made. These
forward-looking statements relate to the Company's beliefs and expectations
regarding clinical trial results and the interpretation of the results, future
research and various protocols which may be conducted, the Company's intention
to develop the hair removal indication and commercialization of a hair removal
product. Such risks and uncertainties include, but are not limited to, the
results of future clinical trials, the status of its patents and proprietary
protection for this indication, reliance on third parties to manufacture (in
compliance with FDA regulations), the availability of funds for ongoing
operations and further development activities and other risks detailed from time
to time in the Company's United States Securities and Exchange Commission (SEC)
filings.
ITEM 7. FINANCIAL STATEMENTS AND OTHER EXHIBITS.
(c) Exhibits
[99] Press Release dated June 11, 1999.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned, hereunto duly authorized.
DUSA PHARMACEUTICALS, INC.
By: /s/ D. Geoffrey Shulman
D. Geoffrey Shulman, MD, FRCPC
President and Chief Executive Officer
Dated: June 11, 1999
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EXHIBIT 99
DUSA PHARMACEUTICALS, INC.
FOR IMMEDIATE RELEASE
DUSA PHARMACEUTICALS, INC. REPORTS POSITIVE RESULTS FROM
LEVULAN(R) PDT CLINICAL TRIAL FOR HAIR REMOVAL
TORONTO, ONTARIO JUNE 11, 1999 - DUSA Pharmaceuticals, Inc. (NASDAQ NMS:
DUSA) today reported positive results from its Phase l/ll multi-center clinical
study using Levulan(R) PDT for hair removal.
Thirty patients were enrolled in this study at 3 clinical trial sites in the
United States. Upper leg (thigh region) areas were treated with topical
Levulan(R) 20% in solution formulation, followed by treatment with red laser
light at 635 nm or broad-bandwidth non-laser red light 4 hours after the
solution was applied. Laser and broadband light was used at a variety of dose
rates and total light doses. Controls used in this study included drug without
light, light with vehicle alone as well as untreated sites. Subjects were
followed for 6 months after a single treatment with Levulan(R) PDT. Both
independent objective human hair counting and computer pattern recognition
methods from standardized photography were used to determine accurate and
objective hair counts.
Efficacy analyses carried out 6 months after the single Levulan(R) PDT treatment
showed the following: For the non-laser light sources, the highest light dose
rate and light dose showed a reduction in hair count from baseline of
approximately 10-15% as compared with that seen in the no treatment control
site. Levulan(R) plus laser light delivered at high doses showed the best
result, a 20-24% reduction as compared with control sites. Mild to moderate
burning and stinging during light exposure was experienced by the majority of
patients using both types of light sources. Hyperpigmentation was also observed
in the majority of patients treated using this protocol, in some cases
persisting throughout the 6 months of follow-up.
Dr. Stuart Marcus, Senior VP and CSO of DUSA stated "We find these results on
hair removal encouraging. This well controlled trial clearly demonstrated a
measurable and meaningful reduction in hair counts. The results show that a
biologically targeted method of hair removal using Levulan(R) and light can
cause significant hair removal following a single treatment, particularly for
actively growing follicles." Dr. Marcus continued "Since as many as 83% of the
hair follicles on the leg are not in an active growth state at any one time, it
was not expected that one treatment would eliminate the majority of hair in that
location. Therefore, the 20-24% hair loss we observed in this early stage trial
may indicate that a high percentage of the actively growing follicles were
destroyed with a single treatment."
<PAGE> 2
"However, substantial research and testing will be required in order to develop
a commercial product. DUSA's future research on hair removal may include
treatment of other body areas with more actively growing hair, multiple
treatments to target hairs growing at different times, use of deep-penetrating
non-laser red light sources, and optimization of drug delivery in order to
minimize hyperpigmentation," Dr. Marcus said. "In summary, this study offers
significant preliminary evidence that Levulan(R) PDT is the first biologically
targeted method for removing human hair and DUSA intends to move forward with
development of this exciting opportunity."
DUSA Pharmaceuticals, Inc. is a development stage pharmaceutical company engaged
primarily in the development of Levulan(R) Photodynamic Therapy (PDT) and
Photodetection (PD) for multiple medical indications. PDT and PD utilize
light-activated compounds such as Levulan(R) to induce a therapeutic or
detection effect. DUSA is a world leader in topically or locally applied PDT and
PD. The Company is incorporated in New Jersey, with executive offices in
Toronto, Ontario, R&D administration in Valhalla, New York and manufacturing,
technology and operations offices in Wilmington, MA.
Except for historical information, this news release contains certain
forward-looking statements that involve known and unknown risk and
uncertainties, which may cause actual results to differ materially from any
future results, performance or achievements expressed or implied by the
statements made. These forward-looking statements relate to the Company's
beliefs and expectations regarding clinical trial results and the interpretation
of the results, future research and various protocols which may be conducted,
the Company's intention to develop the hair removal indication and
commercialization of a hair removal product. Such risks and uncertainties
include, but are not limited to, the results of future clinical trials, the
status of its patents and proprietary protection for this indication, reliance
on third parties to manufacture (in compliance with FDA regulations), the
availability of funds for ongoing operations and further development activities
and other risks detailed from time to time in the Company's United States
Securities and Exchange Commission (SEC) filings.
FOR FURTHER INFORMATION CONTACT:
DUSA PHARMACEUTICALS, INC. - D. Geoffrey Shulman, MD, President & CEO
Tel: 416.363.5059 Fax 416.363.6602 OR VISIT OUR WEB SITE AT
www.dusapharma.com
