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OxyFile #13
Medizone International Completes Arrangements to
Manufacture Equipment for Use in Collaborative Clinical
Trials in Italy to Study Effect of Ozone Therapy on
AIDS, Hepatitis B Patients.
September 8, 1993, New York, New York...........Medizone
International, Inc. (OTC-MZEI) announced today the
completion of contractual arrangements for the manufacture
of he hardware components of five Medizone Drug Delivery
Systems. This equipment is intended to be delivered to
Italy for use in a collaborative research project designed
to examine, in Phase 1 clinical trials, the efficacy of
ozone therapy and Medizone's patented technology in the
treatment of various blood-related human diseases,
including AIDS and Hepatitis B.
Medizone President Dr. Joseph S. Latino explained that the
manufacture of the hardware components of the five Medizone
Drug Delivery Systems for shipment to Italy is a major step
towards fulfillment of the Company's obligations under the
collaborative arrangement. The hardware, at an approximate
cost of $68,500, will incorporate, at an additional cost,
disposable gas exchange modules, devices within the scope
of the Company's proprietary thin film technology process.
By letter agreement with the Italian Scientific Society for
Oxygen-Ozone Therapy ("ISSOT") executed in March, 1993, the
Company also agreed to provide FDA approved protocols for
use by the research group, which was designated by the
Italian Ministry of Health to sponsor the project. Dr.
Latino has been invited to join the research group.
Further communications with the ISSOT indicate that an
estimated 300 patients are expected to participate in the
trials, to be conducted at five university-based Italian
hospitals over a period of approximately nine months.
In accordance with the treatment protocol, patients will
undergo a one-hour treatment procedure on alternate days
during the course of a twelve-week period. The treatment
consists of the withdrawal of 300 cc. (approximately ten
ounces) of blood, to be interfaced with ozone/oxygen gas
through extracorporeal circulation (outside the body), and
then reinfused into the patient. Patients will continue to
be clinically monitored for at least nine months after
completion of treatment.
Dr. Latino reiterated the Company's recent announcement of
the successful completion of two stages of a Canadian
research project that demonstrated preliminary scientific
evidence supporting the use of Medizone's proprietary blood
decontamination technology in a live primate (monkey)
model, further evidencing the scientific rational toward
achieving human trial status.
Medizone International Inc. is developing, Medizone(TM), an
ozone-based treatment for diseases caused by lipid
enveloped viruses, including Acquired Immunodeficiency
Syndrome (AIDS), hepatitis B, and herpes; and is also
developing its patented technology for the decontamination
of blood and blood products.
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