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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: May 9, 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 May
9, 1997, attached hereto as Exhibit 99.
Item 7. Financial Statements and Exhibits
(c) Exhibits
(i) Exhibit 99 -- Press Release dated May 9, 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: May 21, 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: MAY 9, 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 REPORTS ADDITIONAL DATA FROM
KAPOSI'S SARCOMA TRIAL AT INTERNATIONAL CONFERENCE
LA JOLLA, CALIFORNIA -- May 9, 1997 -- Today at The Second International
Conference on Human Herpes Viruses 6, 7, and 8 in Pisa, Italy, LIDAK
Pharmaceuticals (NASDAQ NNM: LDAKA) reported additional data from its clinical
trials with the topical formulation of its proprietary drug, n-docosanol
(LIDAKOL(R)), in the treatment of cutaneous Kaposi's sarcoma.
Previously, the Company reported that topical LIDAKOL exhibited promising
efficacy in reducing the progression and severity of Kaposi's sarcoma (KS) skin
lesions in HIV-1-infected patients. The preliminary results of the study were
presented, in Pisa, by Dr. Michael J. Scolaro, the investigator who conducted
the pilot study in Los Angeles.
LIDAK studied the efficacy and safety of n-docosanol 10% cream as a
treatment of cutaneous KS lesions in ten HIV-1-infected patients. In the study,
twenty-eight KS lesions were evaluated weekly for four weeks for effects of
treatment on pigmentation, size and form (i.e. hard, soft, raised, flat,
swollen) of the lesions. Topical treatment with n-docosanol 10% cream resulted
in a highly significant (p<0.00098) decrease in overall mean lesion size with
nearly 20% of lesions diminishing by more than 50%. Nine of the ten patients
experienced pronounced lightening of lesion pigmentation within four weeks.
Pertinent additional results presented by Dr. Scolaro at the Second
International Conference on Human Herpes Viruses 6, 7, and 8 were as follows:
1) By three months after treatment initiation, all ten patients (100%)
manifested a decrease in lesion size;
2) Histological assessments in two of these patients, comparing
pre-treatment and post-treatment biopsy specimens, has verified the absence of
KS in one instance, and significant regression of the disease in the other.
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May 9, 1997
LIDAK PHARMACEUTICALS REPORTS ADDITIONAL DATA FROM KAPOSI'S
SARCOMA TRIAL AT INTERNATIONAL CONVERENCE
PAGE 2
3) None of the patients developed any apparent signs of systemic spread of
the disease, including oral KS lesions which are generally the first sign of
systemic dissemination of the disease.
Kaposi's sarcoma is a serious AIDS-related disease for which current
therapy is unpredictable and unpleasant. Recent studies have revealed a close
association between KS and human herpesvirus (HHV)-8. Since n-docosanol inhibits
most herpes viruses, including HHV-6, a close relative of HHV-8, LIDAK reasoned
that it was prudent to study the efficacy and safety of n-docosanol 10% as a
treatment of cutaneous KS lesions. Therefore, these preliminary results suggest
a promising role for n-docosanol 10% cream as a first-line therapy in the
treatment of HIV-1-associated cutaneous KS lesions.
LIDAK Pharmaceuticals is developing therapeutic products against virally
caused diseases, inflammatory disorders and cancer.
# # #
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.
