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

tain assays during this stage -- that is, reducing the amount of HIV virus (viral load) or blocking reproduction of the virus -- this batch of in vitro studies is primarily geared towards meeting FDA guidelines that have been designed specifically for the anti-retroviral drugs commonly used to treat HIV/AIDS.

Step three of the IND plan is to complete standard animal safety, pharmacology, and toxicology studies designed to highlight any safety or toxicity issues. The Company has identified a potential laboratory partner to complete these animal studies. The Company's strategy is to submit the IND after completion of step one or two, but prior to step three, on the basis that step three would be completed as a condition to moving ahead in humans. Conditional on availability of funding, the Company believes it will be able to submit an IND application for APi1177 in 3-6 months.

MDT Cancer Study -- Scott and White Hospital

The clinical trial protocol for this study, which is being funded by a grant of $1.5 million to the hospital, is now being prepared for review by the Institutional Review Board (IRB) of Scott and White Hospital located in Temple, Texas and affiliated with Texas A&M University Health Sciences Center.  The review is the final step prior to submission of the Investigator IND (I-IND) to the FDA. IRB review is primarily focused on establishing, monitoring and reviewing the treatment of research subjects in experiments, ensuring certain ethical standards are maintained.

The enrollment and treatment phase of the study can commence following IRB and FDA approval of the protocol. While the Company had earlier indicated that patient enrollment and treatment was expected to start in the spring, the final protocol for the clinical trial was delayed due to the addition of new types of cancers to be studied as well as difficulty in obtaining a non-MDT compound being used in one arm of the study for one type of cancer. The ame
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SOURCE Viral Genetics
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