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INTRODUCTION Virodene Pharmaceutical Holdings (Pty) Ltd. was established to research and develop Virodene® P058 as a New Generation Drug for the management of HIV/AIDS and other auto-immune diseases. The drug formulation, use, and the drug delivery system were patented internationally. Virodene® P058 has been tested on humans in a Pilot Study, a Phase I Study (Safety in healthy volunteers), and a Phase II Study (Safety and efficacy in subjects living with HIV/AIDS). International Clinical Research Organizations (CRO’s) conducted the Clinical Trials according to ICH guidelines for Good Clinical Practice (GCP), thus ensuring the validity and credibility of Clinical Trial Data/Results. These results include the statistical analyses of Virodene® PO58's safety, efficacy, and pharmacokinetic profile The drug application is convenient, non-toxic and user-friendly. On this
web site you will find the history of Virodene® PO58
, as well as the results of the Pilot Study, Phase I and Phase II Clinical
Trials on healthy and HIV/AIDS infected human volunteers. (Access
to members only) Virodene® P058 was discovered in 1996 by Michelle Olga Patricia Visser It was her research into methods of cryopreservation at the University of Pretoria’s Thoracic Surgery Department, which led Ms Visser to observe and record that DMF, the main ingredient of Virodene® P058, had anti-viral properties. Cryopreservation is the study of freezing organs to temperatures as low as minus 196 degrees centigrade, storing them at these temperatures, and then thawing and reviving them to full function. She also developed a novel cryo-protectant solution, key to achieving these objectives. During her research and following an extensive N,N Dimethylformamide (DMF) Literature search for cryo patent purposes, she discovered the clinical use of polar compounds, including DMF, as possible antiviral agents. Ms Visser
extrapolated that DMF’s effectiveness may extend to cover the
viral activities relating to the HIV/AIDS virus, based on the extensive,
documented research available. Legal History of Virodene At the end of 1995, Cryopreservation Technologies cc (CPT) was founded by Ms Michelle Olga Visser, Mr. Jacques Siegfried (Zigi) Visser, and Mr. Carlos G. Tiefenthaler. The purpose of this company was to patent, develop, and market Ms Visser’s inventions, amongst them, Virodene® P058. In October 1997, new Members joined the Close Corporation, under the administration of Mr. Zigi Visser. By this time, the Pilot Study had been successfully completed, and the Phase I Clinical Trial was nearing approval. On 27 November 1997 minority members, Mr. C. N. Fourie, Dr. C. J. Landauer,
Prof. D. du Plessis, and Dr. G du Preez brought an urgent application
- the first of many - for the liquidation of CPT, in order to displace
the majority interest holders and gain control of the administration
of the Corporation.
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