LIDAK Pharmaceuticals Achieves Positive Results With LIDAKOL(R) In
Phase 3 Herpes Clinical Trials; Will Apply to FDA For Marketing
Approval
LA JOLLA, Calif., Aug. 14 /PRNewswire/ -- LIDAK Pharmaceuticals (Nasdaq-NNM:LDAKA) announced that treatment
of recurrent oral herpes outbreaks with its topical anti-viral drug, LIDAKOL(R), resulted in a statistically significant (P=0.035
or less) reduction of the healing times of acute herpes episodes versus the placebo control. This data was established in just
completed, large (743 patients) multi-center, double-blind Phase 3 clinical trials. Healing time is the critical primary end-point
efficacy parameter required by the U.S. Food and Drug Administration (FDA) for new drug marketing approval of this drug.
In secondary end-points evaluated in these trials, treatment with LIDAKOL also reduced, to a statistically significant degree
versus placebo-treatment (P=0.0027), the time until patients were free of herpes-associated symptoms, which included pain,
itching, tingling and burning. As observed in previous studies, there was a higher incidence of aborted outbreaks in
LIDAKOL-treated versus placebo-treated patients. In one subset of patients, the difference in aborted episodes between
LIDAKOL and placebo treatments was statistically- significant (P=0.048), but the difference was not statistically significant
among all patient subsets (P=0.109).
``The favorable outcome of these Phase 3 studies verifies and confirms our long-standing confidence in the clinical importance
of LIDAKOL as a topical treatment for this serious infectious disease caused by herpes viruses,'' stated David H. Katz, M.D.,
president and chief executive officer of LIDAK. ``Anticipating the possibility of these positive results, we continued efforts
during the past 12 months to prepare the required documentation to file a New Drug Application (NDA) for marketing
approval of LIDAKOL with the FDA. We are prepared to complete and file this application by year end 1997,'' Katz
concluded.
Katz also noted that LIDAK plans to make detailed data from the trials available in the future through published articles in
peer reviewed journals and presentations at scientific conferences.
LIDAK Pharmaceuticals has licensed marketing and distribution rights to LIDAKOL in most territorial regions, including
Japan to Grelan Pharmaceuticals, Co., Ltd.; all of Europe and certain African and Mid-East countries to Yamanouchi Europe,
b.v.; Israel to C.T.S. Chemical Industries; Korea to Boryung Pharma; and the entire North American continent to Bristol-
Myers Squibb Company.
In commenting on the results Arend Paasman, the president and chief executive officer of Yamanouchi Europe said, ``As the
European partner of LIDAK in the development of this drug we are encouraged by the results of these combined Phase 3
studies. We believe that the new data, which we will analyze in more detail in the coming weeks, considerably increases our
chances for obtaining marketing approval for LIDAKOL in Europe.''
LIDAK Pharmaceuticals is developing therapeutic products against virally caused diseases, inflammatory disorders, allergies
and asthma, and cancer.
SOURCE: LIDAK Pharmaceuticals
More news for referenced ticker symbols: LDAKA, and related industries: medical.
Help
Important Disclaimers and Legal Information
Questions or Comments?
what happens tomorrow? |
