AEGiS-PRn: Phase II Human Clinical Trial of HIV Patients Using Organetics' Virolyzer Model PS-1 Soon to Start

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

Phase II Human Clinical Trial of HIV Patients Using Organetics' Virolyzer Model PS-1 Soon to Start

PR Newswire - November 29, 1995

MINNEAPOLIS, Nov. 29 /PRNewswire/ -- Organetics, Ltd., is a privately held, Minneapolis, Minn. based medical device corporation that was formed in 1989. Organetics developed and patented the Virolyzer(TM) PS-1 system, an integrated blood perfusion system that performs various extracorporeal treatment procedures. The company will sponsor a Phase II human clinical trial approved by the FDA involving HIV patients using the Company's Virolyzer(TM) Model PS-1 extracorporeal device.

The treatment, which consists of elevating a patient's core body temperature to approximately 107.6 degrees Fahrenheit, or 42 degrees Celsius, for 90 minutes, incorporates the Virolyzer(TM) PS-1 to heat the patient's blood. The Food and Drug Administration approved the Phase II trial after Organetics successfully completed a Phase I trial earlier this year in Livingston, N.J.

Patients will be selected and randomized, with one-half treated with the Virolyzer(TM) PS-1 and one-half receiving current accepted antiretroviral therapy.

During the FDA-approved Phase I study, patients were randomized to receive heat treatments at either 41 degrees Celsius or 42 degrees Celsius for 90 minutes. All patients underwent the therapy without significant complications. In addition to demonstrating improved immune assessment, all patients treated at 42 degrees Celsius in the Phase I trial have experienced an improved quality of life.

CONTACT: Paul Burmeister, General Manager of Organetics, 612-786-8000/ 16:59 EST

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