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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): January 7, 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, DUSA Pharmaceuticals, Inc. (the "Registrant"), reported
on January 7, 1999 interim data from its multi-center Phase I/II clinical trial
on Levulan(R) Photodetection (PD) of bladder cancer in high-risk patients. These
results indicate that Levulan(R) PD was able to detect 13% additional cancers
that were missed with standard white light cystoscopy.
In this study, all patients were examined for bladder cancer using
standard white light cystoscopy as a baseline. Patients then underwent
Levulan(R) PD using blue light, as well as random biopsies (a supplemental
method of bladder cancer detection using a series of biopsies of
normal-appearing areas), in order to compare the number of additional cancers
that could be detected using these techniques. By the end of 1998, clinical
investigators had enrolled and tested 59 patients and had detected a total of 95
cancers, including 24 carcinomas-in-situ (a high-risk type of bladder cancer).
The protocol permits enrollment of up to approximately 100 patients.
The baseline data showed that looking inside the bladder with white
light cystoscopy alone detected 72 cancers, or 75.8%, while missing 23 cancers,
or 24.2%. For carcinomas-in-situ, white light cystoscopy detected 14 cancers, or
58%, but missed 12 cancers, or 42%. The Registrant's management believes that
the interim results demonstrate the limitations of standard white light
cystoscopy.
Levulan(R) and blue light detected an additional 11 cancers, or 13.2%,
including 4 carcinomas-in-situ, or 17%. Random biopsies detected an additional
12 cancers, or 14.3%, including 6 carcinomas-in-situ, or 20%. Only one cancer
detected by Levulan(R) PD was also found by random biopsy. Therefore, the
Registrant believes that Levulan(R) PD and random biopsies may be complementary
detection methods. There were no significant side effects reported. The
Registrant intends to review the interim clinical trial data with a panel of
urology experts to help guide the design of further clinical trials.
In summary, Levulan(R) and blue light detected 13% more cancers than
white light cystoscopy alone, and 17% more of the higher risk carcinomas-in-situ
at this stage of the study.
Except for historical information, this report, including the Exhibit
attached hereto, 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
comparison of Levulan(R) PD to random biopsy as methods of bladder cancer
detection, the analysis of bladder cancer trial results by urologists and the
design of additional trials and the status of discussions with potential
dermatology marketing partners. Such risks and uncertainties include, but are
not limited to the results of clinical trials, whether the Company's NDA filing
will receive marketing approval, the status of its patents and proprietary
protection, reliance on third parties to manufacture (in compliance with FDA
regulations), uncertainties regarding the marketing of its products and whether
a marketing
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alliance will be consummated, unanticipated expenses relating to potential
regulatory requests, 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 January 7, 1999.
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: D. Geoffrey Shulman
D. Geoffrey Shulman, MD, FRCPC
President and Chief Executive Officer
Dated: January 8, 1999
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DUSA Pharmaceuticals, Inc.
For Immediate Release
DUSA ANNOUNCES INTERIM POSITIVE RESULTS IN
BLADDER TRIAL - 13% ADDITIONAL CANCERS DETECTED
Toronto, Ontario, January 7, 1999 - DUSA Pharmaceuticals, Inc. (NASDAQ NMS:
DUSA) reported today that in its multi-center Phase I/II clinical trial on
Levulan(R) Photodetection (PD) of bladder cancer in high-risk patients,
Levulan(R) PD was able to detect 13% additional cancers that were missed with
standard white light cystoscopy.
In this study, all patients were examined for bladder cancer using standard
white light cystoscopy as a baseline. Patients then underwent Levulan(R) PD
using blue light, as well as random biopsies (a supplemental method of bladder
cancer detection using a series of biopsies of normal-appearing areas), in order
to compare the number of additional cancers that could be detected using these
techniques. By the end of 1998, 59 patients had been enrolled and tested, with a
total of 95 cancers detected, including 24 carcinomas-in-situ, a high-risk type
of bladder cancer.
The baseline data showed that looking inside the bladder with white light
cystoscopy alone detected 72 cancers, or 75.8%, while missing 23 cancers, or
24.2%. For carcinomas-in-situ, white light cystoscopy detected 14 cancers, or
58%, but missed 12 cancers, or 42%.
Levulan(R) and blue light detected an additional 11 cancers, or 13.2%, including
4 carcinomas-in-situ, or 17%. Random biopsies detected an additional 12 cancers,
or 14.3%, including 6 carcinomas-in-situ, or 20%. Only one cancer detected by
Levulan(R) PD was also found by random biopsy. Therefore Levulan(R) PD and
random biopsies appear to complement each other. There were no significant side
effects reported.
In summary, Levulan(R) and blue light detected 13% more cancers than white light
cystoscopy alone, and 17% more of the higher risk carcinomas-in-situ.
Dr. Geoffrey Shulman, DUSA's President and CEO, stated "DUSA is very pleased
that Levulan(R) PD was able to detect these additional cancers that were not
found using all other current methods. These interim results, from an ongoing
study, demonstrate the limitations of standard white light cystoscopy, which
missed nearly 25% of bladder cancers. Therefore, it appears that the combination
of Levulan(R) PD, random biopsies and white light cystoscopy are all required to
maximize the detection of bladder cancer. DUSA will now be reviewing the
clinical trial data with a panel of urology experts to help guide the design of
further clinical trials."
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 has filed a New Drug Application (NDA) with the US Food and Drug
Administration (FDA) for its lead indication, pre-cancerous actinic keratoses of
the face and scalp, and is involved in ongoing discussions with potential
dermatology marketing partners. The Company is incorporated in New Jersey, with
executive offices in Toronto, Ontario, and R&D administration in Valhalla, New
York.
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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 comparison of
Levulan(R) PD to random biopsy as methods of bladder cancer detection, the
analysis of bladder cancer trial results by urologists and the design of
additional trials, and the status of discussions with potential dermatology
marketing partners. Such risks and uncertainties include, but are not limited to
the results of clinical trials, whether the Company's NDA filing will receive
marketing approval, the status of its patents and proprietary protection,
reliance on third parties to manufacture (in compliance with FDA regulations),
uncertainties regarding the marketing of its products and whether a marketing
alliance will be consummated unanticipated expenses relating to potential
regulatory requests, 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
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