Viral Genetics, Inc. Releases Initial Findings of Lyme Disease Study

SAN MARINO, Calif.---Viral Genetics, Inc. (OTC:VRAL), a biotechnology company that discovers and develops immune-based therapies, today unveiled to the general public initial findings of its ongoing Lyme Disease study. Viral Genetics initially unveiled its new model and early findings on Saturday, October 18th, at the 2008 International Lyme & Associated Diseases Society (ILADS) Scientific Session. The study, which was financed by a grant specifically allocated for Lyme Disease research, could also potentially offer answers to other immune-based diseases including HIV/AIDS. The team hopes the study will settle the longstanding and controversial debate in the medical community over methods of treatment.

Lyme Disease, Challenges & The Debate

Lyme Disease, the most frequent tick-borne disease in the U.S. and Europe, is caused by bacteria called Borrelia. The disease can have dramatically different outcomes in different people. Symptoms range from debilitating disease to no

Testing is a challenge because symptoms vary and often mimic flu-like symptoms. The bite may not immediately result in antibody production so early negative diagnosis is an issue. The organism is also difficult to culture and slow growing to further complicate detection.

“If infection is detected very early, a round of antibiotics sometimes is enough for some people. In other cases, even with antibiotics, the disease becomes chronic and includes symptoms like arthritis, heart disease, and harm to the nervous system,” said Dr. M. Karen Newell, Ph.D., lead investigator of the study and a professor at the University of Colorado.

Given the vast differences from one patient to another, there is a longstanding debate in the medical community over treatment of Lyme Disease. Some researchers contend Lyme is driven by chronic infection and recommend patients be treated with antibiotics for the long term. Others support the hypothesis that Lyme Disease is a result of autoimmune T cell activation, which occurs subsequent to the initial infection or after the infection has cleared.

“We hope to reconcile this debate, as our model accounts for both the initial disease and the consequent processes that appear similar to autoimmune disease,” said Newell.

Mechanism Of Action

With a commitment to discovering and developing immune-based therapies for HIV and AIDS using its thymus nuclear protein compound (TNP), Viral Genetics’ new model was initially proposed solely for HIV/AIDS. However, by unraveling the mechanism of TNP, Dr. Newell identified its potential promise in other diseases including Lyme.

“Our primary focus is on research and development of new therapies for HIV/AIDS. While we’ve shown consistently that Dr. Newell’s model could potentially serve as a mechanism of action in our HIV/AIDS research and our human trials, up until now, there has not been an animal test model available in HIV/AIDS. Once Dr. Newell identified TNP’s potential in Lyme Disease, where an animal testing model was readily available, we have now clearly shown, for the first time, TNP’s potential for the study of other immune-based diseases,” said Haig Keledjian, co-founder and CEO, Viral Genetics, Inc.

Setting The Stage

The study team attributes the vast differences in people’s response to Lyme Disease to the unique genetic make-up of each individual. The research model developed suggests that a person’s immune response to Borrelia may determine the outcome of the disease.

“To identify the genetic contribution, early studies employed mouse models because there are highly inbred strains that differ only by very well characterized genetic features,” said Newell.

Given each stage of Lyme Disease is characterized by profound inflammation (the “blunt force” of the immune response), the team contends the absence of inflammation is worse. For example, mice with no inflammatory response do not appear as sick, but cannot control infection as quickly as those with intact inflammatory responses.

“In contrast, the response in some mice, which have the appropriate Borrelia TLR 2 and TLR 4, the inflammatory response is sufficient to fight off infection,” added Newell.

The “gate-keepers” of the inflammatory response are the Toll Ligand Receptors (TLR). Bacteria produce Toll ligands that, by binding to the TLR, initiate the inflammatory response. Once that response is triggered, the symptoms for early stages of Lyme Disease are initiated.

In formulating its model, the study team posed the question, what if bacteria get past the gate-keeper and hide out in various tissues, invisible to the immune system? They then asked, what if bacteria find a new disguise, come out of hiding, and the process starts all over again?

Viral Genetics is aimed at finding a key to the gate that unlocks the hiding places without the ‘blunt force’ of the TLR. In other words, the team is now focusing less on the gate-keeper and more on a specific response. In their study model, the key is called a “targeted peptide.”

“Just like a key for each door may be different, the study team contends the ‘targeted peptide’ for each person may depend on their immune traits, and therefore, will dictate how the disease manifests itself,” said Newell.

Summary of Key Findings

Early Lyme Disease research has resulted in three significant findings. First, the study team has identified and synthesized “key” peptides that are predicted to have high binding affinity to an individual’s immune cells based on the genetic traits of their immune system. Secondly, the team has tested the newly identified peptides in mouse models in which the immunological genes are very well characterized. Lastly, the team has shown that the “targeted, computationally predicted peptides” significantly reduce the number and “activation state” of the cells responding to Borrelia proteins.

“In summary, we have seen a dramatic reduction in the number of non-specifically ‘activated’ cells--likely as a result of reducing the inflammation in response to inflammatory Borrelia protein. Our early findings are promising and potentially could unlock the mysteries of Lyme Disease as well as other immune-based diseases including HIV/AIDS. We look forward to moving into the clinical phase of research,” added Newell.

About Viral Genetics

Viral Genetics, Inc. is a biotechnology company that discovers and develops immune-based therapies for HIV and AIDS using its thymus nuclear protein compound (TNP). The company recently entered into an Exclusive License Agreement with the University of Colorado and V-Clip Pharmaceuticals (a subsidiary of the Company) to license technology developed by M. Karen Newell, PhD that appears to explain TNP and provide a means to optimize therapies based on TNP for future clinical trials. TNP may have other potential applications for other infectious, autoimmune, and immunological deficiency diseases that the company intends to study in the future. Viral Genetics believes that its investigational HIV/AIDS drug based on TNP, called VGV-1, represents a unique approach to treating HIV due to the apparently novel mechanism, low toxicity profile, simple dosing regimen, and short-course of treatment. As a type of immune-based therapy, it focuses on boosting the immune system to allow the body to fight HIV more efficiently. VGV-1 has been studied in five human clinical trials for the treatment of HIV/AIDS. Online at www.viralgenetics.com

This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Viral Genetics, Inc. from time to time in its periodic reports filed with the SEC. VGV-1 is not approved by the US Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world. While Viral Genetics believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Viral Genetics to establish the efficacy of VGV-1 in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of VGV-1 in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the forward-looking statements should not be regarded as a representation by Viral Genetics or any other person that the objectives and plans of Viral Genetics will be achieved.