Viral Genetics (VRAL)

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About Viral Genetics, Inc.

Viral Genetics, Inc. is a biotechnology company researching new treatments and methods of detection for HIV/AIDS, Lyme Disease, staph and strep, cancer and certain other autoimmune and infectious diseases. Two approaches based on patent rights licensed from the University of Colorado and University of Vermont form the basis of our research: Targeted Peptides Therapies (TPT) and Metabolic Disruption Technology (MDT). TPTs are custom-designed protein fragment that work to modify certain immune system reactions that we believe cause or worsen some diseases. The TPT compounds we are studying represent in some sense the second generation of our earlier thymus nuclear protein or “TNP” therapy. MDT encompasses a way to change how some types of cells use fat and sugar/carbohydrates for energy. By manipulating metabolic processes, we believe we can cause some harmful cells – including drug-resistant cancer cells – to die. The same MDT approach has also recently been discovered to have potential in encouraging the production of oils from algae and other plants. As a result of this, we established a subsidiary called VG Energy to develop these applications.

Our management team and advisors include two Nobel Laureates, Dr. Luc Montagnier and Dr. Baruch Blumberg, leading researchers, business and intellectual property veterans and drug development experts.

Technology: Overview As a discovery company, we are focused on finding and developing treatments and methods of detection for HIV/AIDS, Lyme Disease, staph and strep infection, cancer and certain other autoimmune and infectious diseases. Two approaches developed by Dr. M. Karen Newell-Rogers form the basis of our research: Targeted Peptides Therapies (TPT) and Metabolic Disruption Technology (MDT). All of our compounds are in the late preclinical stage and we are now preparing to submit pre-IND documents to the FDA for clinical trials in the US. An investigator’s IND for our glioblastoma therapy using an MDT approach is planned for January 2011.

TPTs are custom-designed protein fragments that work to modify certain immune system reactions that we believe cause or worsen some inflammatory diseases. The TPT compounds we are studying represent in some sense the second generation of our earlier TNP therapy. MDT encompasses a way to change how some types of cells use fat, amino acids and sugars or carbohydrates for energy. By manipulating metabolic processes, we can cause some harmful cells – including drug-resistant cancer cells – to die. The same MDT approach has also recently been discovered to have potential in encouraging the production and storage of biofuels from algae and other plants.

Our Vision Our vision is to build on the innovative research being conducted by Dr. M. Karen Newell-Rogers, by developing the technology from the laboratory stage through to clinical trials and seeking partners for late-stage clinical development. Dr. Newell-Rogers’s work in the areas of Targeted Peptides Technology (TPT) and Metabolic Disruption Technology (MDT) are revealing new facets of many diseases and the body’s response to them. In doing so, we believe that her work is outlining solutions to some of the world’s major health challenges including HIV/AIDS, drug-resistant cancers and autoimmune disease.

Targeted Peptides Explaining Targeted Peptide Technology ("TPT")

This technology targets the body's immune cells and seems to explain the mechanism behind some autoimmune diseases while presenting a possible solution. We are using TPT to develop compounds for treatment of Lyme Disease (VGV-L), Staphylococcus, Streptococcus and Sepsis infection (VGV-S), and a second-generation HIV/AIDS therapy (VGV-X). We are also studying TPT approaches to treatment of Multiple Sclerosis.

Autoimmune diseases occur when the body reacts to itself or self-tissues. In some cases, an external threat from disease-causing organisms activates too many of certain types of immune cells which in turn cause damage the body. A physical trait of those cells also makes them impervious to the body's natural defense system that would ordinarily limit their numbers.

TPT works by tricking those impervious cells into dropping their defenses. They can be fooled into releasing their protective shields, swapping the shield for a synthetic TPT-polypeptide instead. Those peptides, created by our research team, have been engineered to make the cell susceptible to the body's natural defenses. We expect our TPT drug compounds to enable the body to destroy the cells that help trigger the symptoms of autoimmune diseases.

TPT is in some ways our successor to the TNP or thymus nuclear protein compound we previously studied. TNP is a cocktail of histone protein fragments that includes over 2500 peptides. TNP is derived from the thymus, where immune cells develop. Our early line of research investigated TNP for the potential to treat autoimmune diseases and HIV/AIDS, and we conducted six human clinical trials of a TNP-based drug. Since then, TPT has been developed based on the potential identification and explanation of the therapeutic benefit first seen with TNP.

Metabolic Disruption Explaining Metabolic Disruption Technology ("MDT")

A growing body of research indicates that interfering with cell metabolism is the key to targeting cancer cells. The way a cell metabolizes its sources of energy appears to determine whether it will survive the most common treatments for cancer--chemotherapy and radiation. Cells that rely on glucose (or sugar) for fuel are easily damaged and killed. Cells that can run on fat can become deadly. They continue to survive and even thrive during cancer treatments--thereby assisting in the development of drug resistant tumors that can become lethal to their victims.

Every cell in the body produces, consumes, and stores energy using a distinct metabolic strategy to perform its normal functions. Each cell can use carbohydrate, protein, or fat in different proportions to insure that the cell has sufficient energy. The cell’s choice of fuel, i.e. the cell’s metabolic strategy, will change depending on its activation or differentiation state as well as its environment. For example, a cell that is dividing has different energy demands than one that is non-dividing and, thus, must employ an alternative metabolic strategy. Because, in general, cancer cells grow very rapidly, cancer cells have very high energy demands. We have learned that some of the mechanisms the tumor cells use to meet their energy demands are unique to the tumor cell and are not used by normal cells, suggesting that those specific pathways could make clinically relevant therapeutic targets. As a result, our work now indicates that when the tumor cells’ specific energy strategies are interrupted with “metabolic disrupting” agents, the consequences are two-fold: the cancer cells can no longer generate energy needed to survive and the disruption of the intracellular energy levels reduces their ability to repair damage from other cytotoxic agents, resulting in a much greater sensitivity to chemotherapy and radiation.

Tumor cells exhibit at least two generalizeable metabolic features that we have chosen as selective targets, high rate glycolysis (the process of breaking down glucose to smaller carbon-containing units in the cytosol of the cell) and fatty acid oxidation (the process of breaking fats down to smaller carbon containing units in the cell’s powerhouse, the mitochondria). The preferential use of fatty acid oxidation in the mitochondria of drug resistant cells is a particularly important focus of our therapeutic strategy because drug resistance, either acquired through drug treatment or inherent drug resistance, is the leading cause of death for cancer patients. For all of these reasons, our initial clinical compounds are comprised of pharmaceutical compositions that interfere with various aspects of high rate glycolysis and fatty acid oxidation. These include (but are not limited to) dichloroacetate (DCA), etomoxir and 2-deoxyglucose (2-DG).

DCA is an orally-active small molecule drug that inhibits certain aspects of high rate glycolysis and fatty acid metabolism. DCA is very close in structure to an essential intermediate in glucose metabolism, the molecule pyruvate. By mimicking the effects of pyruvate, DCA likely acts in two capacities: first, to function as an inhibitor of high rate glycolysis by sending the cell the message that nutrient reserves are full and second, to interfere with pyruvate dehydrogenase kinase, an enzyme involved in the mitochondrial switch to fatty acid oxidation under conditions of starvation. The second line of our approach involves two other metabolic inhibitors known as etomoxir and 2-DG, which are also orally-active small molecules that selectively block distinct aspects of fatty acid oxidation and glucose/carbohydrate metabolism respectively. Our research indicates that they are capable of interfering with the metabolic strategy of both drug sensitive and multi-drug resistant tumor cells. The choice of these two compounds is the result of elucidating the two distinct metabolic characteristics of drug resistant tumor cells. Preliminary studies both in vitro and in tumor bearing mice have demonstrated a lack of toxicity and impressive therapeutic activity of etomoxir in multi-drug resistant cancer cells and an even more potent combined effect with 2-deoxyglucose on both drug sensitive and drug resistant tumor cells. In addition, these two compounds have striking therapeutic activity in tumor-bearing mice when used together, or in conjunction with, standard chemotherapy.

Through the use of these compounds and others with similar activities, our portfolio of metabolic disrupting agents include agents that disrupt high rate glycolysis, agents that interfere at various control points in fatty acid oxidation and the use of either or both of these categories of metabolic disrupting agents in combination with conventional chemotherapeutic agents to reverse drug resistance. The Company has planned a clinical trial of etomoxir and 2-deoxyglucose on drug-resistant glioblastoma patients under an Investigator’s Investigational New Drug (IND) Application with the FDA for January 2011.

We established a subsidiary called MetaCytoLytics to investigate these agents and several other novel compounds in wound healing (since it too is characterized by proliferating cells). A second, separate subsidiary called VG Energy is researching the use of metabolic disruption agents to enhance the fatty acid content of plants for yield enhancement of plant oils including biofuels.

Development: Overview Building on both our TPT and MDT technologies, we are now developing compounds for study in a variety of diseases focusing on the broad areas of infectious disease, oncology and autoimmunity. Please review the target indications at the menu on the left for more information.

Development: VGV-X: HIV/AIDS Six international, human clinical trials found that our first-generation HIV/AIDS drug compound significantly reduced the viral load by over 90-95% in some patients. That therapy led to the development of a second generation TPT drug compound called VGV-X. We believe that VGV-X may address the reason that our first HIV/AIDS drug reduced the viral load in some patients, but not others. Preparing this therapeutic approach for human clinical trials is a top priority.

Current antiviral treatments for HIV and AIDS are drug combinations that are expensive, difficult to access in many areas of the world, and accompanied by a number of complications, including moderate to severe side effects, onerous dosing regimens, multiple drug interactions, and the development of drug resistant strains of the HIV virus. Based on our experience with an earlier version of VGV-X, we are hopeful that it will continue to demonstrate only moderate side effects and a less onerous dosing regimen.

With over 40 million cases of HIV in the world and growing, including over 25 million in Sub-Saharan Africa alone, we believe that such a therapy would be of significant interest.

Development: VGV-L: Lyme Disease Using the TPT technology, an injection called VGV-L has been developed to treat Lyme disease, an illness that saw a 100% increase in CDC-confirmed cases from 1991 to 2006. Animal studies have been completed with positive results. We are now in the process of introducing our research to the FDA.

This research was supported by grants from two not-for-profit organizations that saw the promise in our approach helping enable us to reach this phase of development. The proposed therapy, like several others in our R&D pipeline, is based on TPT and uses synthetic peptides to "trick" cells that may be responsible for harmful symptoms, making them vulnerable to the body's natural immune response mechanism.

Development: VGV-S: Staphylococcus, Streptococcus And Sepsis Our new VGV-S drug compound has been found to provide an alternative to traditional antibiotics in laboratory animals infected with Staphylococcus or with high levels of Streptococcus. Testing during 2009 determined that some infected mice treated with VGV-S, made full recoveries. A control group of sick animals that were not treated with this therapy either took much longer to recover or did not survive the infections.

The animal results of infection with these bacteria also suggest that VGV-S may have the potential to treat sepsis, a life-threatening systemic infection.

Like some of our other drug compounds, it is based on TPT discoveries made by Dr. Newell-Rogers and her team. Laboratory testing continues, both in the test tube and in animal studies, in preparation for possibly advancing this drug to human clinical trials.

Development: Cancer Based on research published in 2002 the underlying MDT technology seems to identify unique characteristics of drug resistant cancer cells and is rapidly gaining attention as having the potential to offer hope to cancer patients. The early, patented work by Dr. Newell-Rogers has been validated and reinforced by recent research published by other scientists.

Working with several compounds including dichloroacetate (DCA), etomoxir and 2-deoxyglucose (2-DG), we are now working to develop a drug compound and dosing based on MDT for victims of glioblastoma, a particularly deadly brain tumor. Our expectation is that this therapy will be used in conjunction with traditional cancer treatments such as chemotherapy and radiation. The drug's role will be to target the cells capable of surviving those treatments. Drug resistance is the leading cause of death among cancer patients. Our hope is that our new approach may provide novel therapy aimed at dealing with drug resistance.

Viral Genetics has created a wholly owned subsidiary called MetaCytoLytics, Inc., dedicated to advancing new treatments based on MDT.

Development: Detecting Disease Through Saliva Research continues on one of our first areas of interest--a kit that enables physicians to detect disease through a serum or saliva test. Our initial work, based on a thymus nuclear protein compound (TNP), determined that serum can be used as a "litmus" test indicating some types of illness. Recent work suggests that saliva may provide an alternative to serum for detection. The priority for Viral Genetics' research team is to enhance the test's sensitivity and specificity for detecting a variety of illnesses.

Development: Other During and after our human clinical trials, we observed that some test subjects suffering from other clinical conditions and diseases, such as oral and genital herpes, Hepatitis C infection, rheumatoid arthritis, and others, reported anecdotal improvements in the symptoms of these other illnesses.

Our laboratory research in both MDT and TPT has further established these other areas of research, and our Exclusive Licenses have granted us exclusive rights to do so. As part of our future plan, we intend to explore these other areas.

MetaCytoLytics MetaCytoLytics is a subsidiary of Viral Genetics that is focused on the development of our licensed Metabolic Disruption technology that has application in the treatment of certain diseases including drug-resistant tumors through the mechanism of manipulating how certain types of cells use or store fats and sugars to generate internal energy.

Through manipulation of tumor cells internal metabolisms, we are studying how to cause their death and are working to develop treatments for drug resistant tumors – the leading cause of death from cancer. Currently the company is working at development of a compound for the treatment of glioblastoma, a deadly form of brain cancer. A clinical trial at Scott and White Hospital under an investigator’s IND is planned for January 2011.

The compounds under study include dichloroacetic acid (DCA) and a combination of 2 deoxyglucose and etoximir. DCA has been the subject of human clinical trials by unrelated third parties. Our licensed patent rights cover the use of the compounds and the mechanisms underlying them.

We have also established a subsidiary called VG Energy to pursue the non-human applications of the MDT technology, specifically the enhancement of yields of plant oils including refinable oil from algae for biofuel.

Visit: VG Energy, Inc. to learn more.