OxyFile #341
MEDIZONE ITALIAN TRIALS INFORMATION FROM SEC DOCUMENTS
During the last quarter of 1995, Medizone International, Inc.
(the "Company") was advised by San Raffaele Hospital of the
University of Milan ("Milan") and the Regional Oncology Center and
AIDS Treatment Center at Aviano ("Aviano") that their respective
ethics committees had approved the commencement of human trials to
study the effects of Medizone (the drug) on patients infected with
HIV (in the case of Aviano) and Hepatitis B (chronic-active)
trials (in the case of Milan), subject to the receipt of specific
affirmative approvals for these trials from the Italian Ministry
of Health.
On May 8, 1996, the Italian Ministry of Health issued its
approvals, which were thereafter communicated to the Company. The
Italian Scientific Society for Ozone Oxygen Therapy ("ISSOT") will
supervise these Phase I clinical trials which were designed by the
Company as classical Phase I trials of its patents (both of
Medizone, the drug, and the Company's technology) to determine,
in a dose-ranging study, the relative toxicity of this treatment
against surrogate markers of efficacy. Each of these trials is
designed to take approximately one year to complete, although
there can be no assurance that such time-frame will be adhered to
once the trials commence.