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: March 14, 1996
(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
On March 14, 1996, the Company announced the results of a
preliminary review of two Phase 3 U.S. and Canadian clinical
trials conducted jointly with its European licensee, Yamanouchi
Europe B.V., of n-docosanol 10% cream (LIDAKOLTM) in the
treatment of oral herpes. The double blind, placebo-controlled
studies, in which patients were treated early in the course of
oral herpes episodes, demonstrated that LIDAKOL had a very good
safety profile and was well-tolerated. With regard to the
primary study endpoint of healing time, the duration of cold sore
lesions averaged 5 days in both the LIDAKOL and placebo-treated
groups. The duration of oral herpes episodes among these early-
treatment patients was significantly reduced, by 35% or more, as
compared to the average duration of prior untreated episodes
reported by these patients.
In addition, in one of the studies LIDAKOL treatment
resulted in a statistically significant benefit as compared to
placebo in aborting the progression of oral herpes outbreaks to
the vesicle, or blister, stage in patients who initiated
treatment when they experienced redness as the early sign of an
outbreak. Lesions were aborted in 76% (16 of 21 patients) of the
LIDAKOL-treated patients versus 37% (7 of 19 patients) of the
placebo-treated group.
As a result of the outcome of the studies, the Company
believes it will be required to conduct another clinical study
before it can file for marketing approval by the FDA of LIDAKOL
as an early-stage treatment of oral herpes. The additional
clinical study will be designed to verify the possible anti-
herpes activity of the control substance, and to demonstrate
statistically significant reduction in healing time by LIDAKOL
treatment versus an inactive placebo.
The Company has sponsored three separate double-blind,
placebo-controlled Phase 3 clinical studies of LIDAKOL in the
United States and Canada. The results now being reported are
from two of these studies in which a total of 648 immunocompetent
patients initiated treatment early in an oral herpes episode
(involving an initial sensation, redness, or a small bump, but
not a blister). The third study conducted in 544 immunocompetent
patients who initiated treatment at later stages of an episode
(where blisters and/or ulcers had already appeared) has been
concluded and the results are currently being analyzed.
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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: March 14, 1996 By:/s/Michael H. Lorber
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Vice President/CFO & Secretary
