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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report: June 24, 1997
(Date of earliest event reported)
LIDAK PHARMACEUTICALS
(Exact name of registrant as specified in its charter)
CALIFORNIA
(State or other jurisdiction of incorporation)
0-18734 33-0314804
(Commission File Number) (IRS Employer
Identification No.)
11077 North Torrey Pines Road, La Jolla, California 92037
(Address of principal executive offices) (Zip code)
(619) 558-0364
(Registrants telephone number, including area code)
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Item 5. OTHER EVENTS
The registrant incorporates by reference herein the press release dated
June 24, 1997, attached hereto as Exhibit 99.
Item 7. Financial Statements and Exhibits
(c) Exhibits
(i) Exhibit 99 -- Press Release dated June 24, 1997.
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
LIDAK PHARMACEUTICALS
Date: June 27, 1997 By:/s/David H. Katz
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David H. Katz, M.D.
President and Chief Executive Officer
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EXHIBIT 99
DATE: June 24, 1997 LIDAK PHARMACEUTICALS CONTACT: Lisa Dawn Katz
NEWS RELEASE Director,
Communications &
Investor Relations
LIDAK Pharmaceuticals
(619) 558-0364,
ext. 256
David H. Katz, M.D.
President/CEO
LIDAK Pharmaceuticals
(619) 450-1538
LIDAK PHARMACEUTICALS' MALIGNANT MELANOMA VACCINE, LP2307
PHASE 1/2 CLINICAL TRIAL COMPLETED SUCCESSFULLY
LA JOLLA, CALIFORNIA -- June 24, 1997 -- LIDAK Pharmaceuticals (NASDAQ
NNM: LDAKA) reported today the completion of a Phase 1/2 clinical trial studying
the safety and efficacy of its Large Multivalent Immunogen (LMI) vaccine,
LP2307, in stage three and four malignant melanoma patients. LP2307 Injectable
Suspension is created by attaching melanoma cellular antigens onto cell-size
microspheres. The technology aims to elicit tumor-specific immune responses
against each patient's melanoma with possible stabilization of the disease and
prolongation of life. This trial was the first time LP2307 had been tested in
humans, and the treatment proved to be safe and well-tolerated. The possible
efficacy of this treatment is now under review.
A total of 17 patients, one with stage three and 16 with stage four
malignant melanoma, completed the Phase 1/2 clinical trial which was conducted
by Dr. Malcolm S. Mitchell, Director of the Center for Biological Therapy and
Melanoma Research at the Cancer Center of the University of California, San
Diego. Criteria for the study conformed with the staging system adopted by the
American Joint Committee on Cancer and defined stage three melanoma as limited
nodal metastases and stage four as advanced regional metastases or any patient
with distant metastases. This clinical trial was designed to examine primary
endpoints of safety, tolerance and to determine the optimum biological dose of
LP2307. The efficacy of the study will be evaluated as a secondary endpoint with
consideration for an expanded trial. The study design called for three groups of
six patients. The patients in each group received three monthly injections at
one of three dose levels, with each patient being followed for a total of four
months. LP2307 at all of the dose levels was well tolerated and five of the
patients in the study continued treatment beyond the four month initial phase.
LIDAK anticipates having a final analysis of all of the study endpoints by the
end of the third quarter of 1997.
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June 24, 1997
LIDAK PHARMACEUTICALS' MALIGNANT MELANOMA VACCINE, LP2307
PHASE 1/2 CLINICAL TRIAL COMPLETED SUCCESSFULLY
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LIDAK's LMI technology is a novel proprietary approach to immunotherapy of
cancer designed to stimulate tumor-specific killer cells, known as cytotoxic T
lymphocytes (CTL), to combat invading tumor cells in the cancer-bearing host. In
experimental laboratory models, LMI has been shown to stimulate increased CTL
responses specific to a variety of tumor types and to improve the survival rates
in cancer bearing mice.
Commenting on the announcement, David H. Katz, M.D., LIDAK's president and
chief executive officer, stated, "Accomplishing the successful translation from
in vivo laboratory models to human patients in the clinic represents an
important milestone in our development efforts with the LMI technology. It is
encouraging that LP2307 Injectable Suspension appears to be safe and
well-tolerated. We hope that further evaluation of the study will support data
from our experimental laboratory models, in which LMI has been shown to
stimulate increased CTL responses specific to a variety of tumor types and to
improve the survival rates of cancer-bearing mice." Malcolm S. Mitchell, M.D.
added, "I was pleased to have completed this initial study of a novel
therapeutic technology for malignant melanoma with LIDAK Pharmaceuticals.
LP2307 has proved to be safe and well-tolerated in this trial."
LIDAK Pharmaceuticals is developing therapeutic products against virally
caused diseases, inflammatory disorders and cancer. LIDAK recently completed the
patient enrollment and treatment portion of two Phase 3 clinical trials studying
its proprietary drug, n-docosanol (LIDAKOL(R)) as a treatment for oral herpes.
The studies were conducted on over six hundred patients at 22 clinical sites
around the United States. The Company anticipates data availability during the
summer of 1997, as previously reported.
# # #
The information contained in this press release should be reviewed in
conjunction with the Company's Annual Report on Form 10-K and other publicly
available information regarding the Company, copies of which are available from
the Company upon request. Such publicly available information sets forth many
risks and uncertainties related to the Company's business, including risks and
uncertainties related to drug development and clinical trials.
