AEGiS-PRn: Medizone Signs Letters of Intent to Commence Human HIV/AIDS Clinical Trials in Europe; Improved Ozone Technology Delivery System to Enhance Market Potential

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Medizone Signs Letters of Intent to Commence Human HIV/AIDS Clinical Trials in Europe; Improved Ozone Technology Delivery System to Enhance Market Potential

PR Newswire; Tuesday December 2, 7:36 am EST

SALT LAKE CITY, Dec. 2 /PRNewswire/ -- Medizone International, Inc. (Bulletin Board: MZEI.U) ("Medizone") announced today that it will begin an aggressive clinical trial program in Italy during the second quarter of 1998, with an in-vitro study for viralcidal and dose-ranging activity. The initial Phase I trial conducted in healthy adults will test the safety, tolerance and toxicity of the MEDIZONE(TM), patented "thin-film" ozone technology and delivery system. Phase II trials will follow testing the efficacy of MEDIZONE(TM) in treating HIV/AIDS and Hepatitis B patients. The initial Phase II trials will address the pharmacokinetics of the current antiretroviral drugs ZDV, 3TC and Indinavir used on patients during concomitant administration of MEDIZONE(TM). It is expected that the antiretroviral activity of MEDIZONE(TM), as demonstrated in previous animal studies, will prove to be an adjunct to existing therapies, thereby prolonging and improving quality of life.

Following extensive discussions in Italy involving Milton G. Adair, President and CEO, and Dr. Gerard Sunnen, Director of Science, letters of intent were signed with three key clinical researchers. Mr. Adair stated, "We are very fortunate to have such a prominent scientist as Dr. Marianno Franzini, Professor at the Universita of Pavia and President of the Italian Scientific Society for Oxygen-Ozone Therapy ("ISSOT") agree to perform a Phase I study." In addition, two distinguished investigators, Dr. Umberto Tirelli, Chief, Division of Oncology and AIDS at the National Cancer Center, Aviano, Italy and Dr. Carlo Giaquinto, Professor at the Department of Pediatria, Universita di Padova, Padova, Italy have agreed to perform Phase II HIV/AlDS and Hepatitis B studies upon the completion of Dr. Franzini's study. Professor Tirelli was a guest of the Stanford University Department of Medical Oncology last summer. Professor Giaquinto, a former Fellow at the Albert Einstein School of Medicine in New York, has been the invited speaker on Pediatric AIDS at more than 100 international conferences. He is the author or co-author of more than 110 articles and books published nationally and internationally. Mr. Adair continued, "Medizone has a unique and exciting opportunity to work with such gifted men."

Mr. Adair stated, "We originally planned to begin our human trials during the first quarter of 1998, however, while in Italy, we were presented with the opportunity to significantly improve the design of our patented "thin-film" ozone generating delivery system. The Company believes the redesign could dramatically enhance our overall market potential. Based on this potential, we aggressively began pursuing this opportunity even though it meant delaying the trials by a few months." Increasing overall market potential could enhance future revenue projections which should more than offset the short delay in starting the trials.

All clinical trials will be conducted to meet the European Union standards which are as rigorous as the United States Food and Drug Administration standards. The new technology delivery system will also be designed and manufactured to European ISO 9002 standards, considered by many as the most demanding standard in the world. To support its European activity, the Company is in negotiations with a highly reputable Italian contract research organization to oversee and monitor all phases of the clinical research.

In other news, the Company announced that their agreement with JRH Biosciences of Lenexa, Kansas, announced April 22, 1997, has been cancelled. "Medizone is in discussions with other potential development partners that offer a better fit with Company objectives. Licensing our patented viral decontamination process specially for the treatment of bovine serum offers us a significant commercial opportunity. We want to find the strongest partner and negotiate the most favorable terms possible," stated Mr. Adair.

Medizone International, Inc. is a research and development stage company engaged in the development of an ozone-based treatment for diseases caused by lipid enveloped viruses, including Acquired Immune Deficiency Syndrome (AIDS), Hepatitis B and Herpes; and in the development of its patented technology for the decontamination of blood and blood products. For information call CTC, 937-434-2700, or Medizone International, Inc., 801-274-8400.

This press release contains forward-looking statements about the Company's goals and anticipated future performance. The industry in which the Company proposes to operate is dynamic and intensely competitive and there are many factors that could cause the forward-looking statements contained herein not to occur or the timing of their occurrence to be delayed. With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve substantial risks and uncertainties, including, but not limited to, the results of ongoing clinical studies, economic conditions, product and technology development, production efficiencies, product demand, competitive products and competitive environment, availability of raw materials and critical manufacturing equipment and facilities and other risks identified in filings made with the Securities and Exchange Commission.

SOURCE: Medizone International, Inc.

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