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Viral Genetics Updates HIV/AIDS and Drug Resistant Cancer Research Programs
Date:6/14/2011

SAN MARINO, Calif., June 14, 2011 /PRNewswire/ -- Viral Genetics, Inc. (Pinksheets: VRAL) continues to make the transition to a clinical-stage company. The Company's two lead pharmaceutical programs -- APi1177 for HIV/AIDS, and various Metabolic Disruption (MDT) compounds for drug-resistant cancers -- are being advanced towards clinical development under sponsor- or investigator-initiated Investigational New Drug (IND) pathways. An IND application is the submission that a company provides to the FDA requesting permission to conduct clinical trials on humans. Each program is continuing as detailed below.  

HIV/AIDS -- APi1177 Pre-IND

The Company recently communicated with the United States Food and Drug Administration (FDA) through submission of a pre-IND package for APi1177. As a result of this dialogue, the Company is focused on a three-step plan leading towards filing a full IND and clinical trials in the US.

Step one of the plan is securing a manufacturer to supply APi1177 in sufficient quantity and meeting established quality standards throughout the remainder of the development and clinical trial process. Up until this point the Company's manufacturer has produced "research grade" drug which has been sufficient for early preclinical studies conducted to date, but all drug used going forward must be produced in compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards. A suitable manufacturer has been identified and they are now working with the Company's research-grade manufacturer to reproduce the product used in earlier-stage studies.

Upon completion of this, step two of the development plan is to move forward with a limited number of relatively-brief laboratory studies designed to establish any "in vitro" antiviral efficacy for APi1177 as well as to highlight any potential issues relating to interaction with existing HIV antiviral drugs. While "efficacy" results may be achieved in cer
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SOURCE Viral Genetics
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