Viral Genetics Issues 2010 Year in Review, 2011 Outlook Viral Genetics (USOTC:VRAL) Intraday Stock Chart
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Viral Genetics (Pink Sheets: VRAL) ("the Company") has released its 2010 Year in Review and 2011 Outlook by CEO Haig Keledjian. The following is a brief summary of that report. A copy of the full 14-page report is now available on the company website (www.viralgenetics.com). Additionally, the company has now added two comprehensive research reports available on the website by Zacks Equity Research and Research 2.0. In 2010 the Company moved closer to its goal of bringing new drugs to market by positioning itself for the significant step of advancing the clinical trial process in 2011. The Company expanded its research facilities and capabilities and is looking forward to gathering data from potential drug therapies using its patented Metabolic Disruption Technology (MDT) and Targeted Peptide Technology (TPT). New data sources include an investigator study of MDT therapies for drug-resistant cancers at Scott and White Hospital this spring, funded in part by a recent $1.5 million anonymous grant to the hospital.
"Progress throughout the past year has brought us closer to fulfilling our mission of bringing new drug therapies to the marketplace," notes Viral Genetics CEO Haig Keledjian in the review. "In 2010 we made concrete, measurable steps towards that goal, while also expanding our research to include the development of biofuel technologies through our new subsidiary, VG Energy. We're well positioned to execute against our business objectives in 2011."
Viral Genetics' patents and proprietary technology are being developed in collaboration with several Texas A&M University researchers and support from the State of Texas. Last year, the Company's lead scientist, Dr. M. Karen Newell Rogers, joined the faculty at Texas A&M University Health Science Center's College of Medicine and the Department of Surgery, Scott and White Hospital in Temple, Texas. Now located in a hospital environment and surrounded by leading clinicians, Dr. Newell Rogers has access to significantly enhanced resources for transitioning her research from the lab to patients in the clinic. Additionally, she was awarded a $750,000 grant from the Texas Emerging Technologies Fund to research biofuels, which enabled the opening of a new research facility in Georgetown, Texas. In parallel, the Company expanded its research team and brought on specialized staff, in part to assist in the regulatory process with the U.S. Food and Drug Administration (FDA).
The Company in 2010 submitted to the FDA a pre-IND (Investigational New Drug) letter for its Targeted Peptide HIV/AIDS compound, APi1177 (also known as VGV-X when in injectable form). The FDA issued a pre-IND number and a date in the first quarter of 2011 to meet with the agency for a formal review of the drug's development path and to present the plan for US trials. A "pre-IND meeting" precedes a full Investigational New Drug application and typically requires additional preclinical studies, but provides comments and feedback from the FDA that will essentially facilitate a blueprint for Viral Genetics' researchers to follow in developing the drug.
Building on the successes of 2010, researchers at Scott and White Hospital anticipate initiating clinical trials in 2011 to treat "treatment refractory" patients with drug-resistant forms of skin, ovarian, breast, and other cancers under investigator INDs for Viral Genetics' MDT compounds. An "investigator study" is one in which a physician directly asks the FDA for permission to use experimental drug compounds on patients that generally are considered to have limited treatment options. The principle investigator on the initiative is Ed Childs, M.D., with Juan Posada, M.D., serving as the lead oncologist and co-investigator. The compounds being studied in these trials are combinations of drugs or other compounds that, individually, are already approved by the FDA for non-cancer indications, but will be used in combination with standard cancer treatments with the goal of enhancing overall effectiveness in shrinking or eliminating tumors. Viral Genetics' intellectual property in this area protects the actual compounds and combinations of compounds for use in cancer therapy, as well as the underlying methods targeting the mechanism of action.
Potential Applications in Biofuels
Dr. Newell Rogers' work in 2010 with MDT, used to target the unique metabolic demands of tumor cells, has also shown potential in modifying the metabolic strategy of algae and plants through the same underlying mechanism, thus creating a new approach for improving the yield of biofuels including raising algae oil yields in pilot studies by 300%. The promise of this technology prompted Viral Genetics to form VG Energy, Inc. to further develop and potentially market biofuel technology. A working preliminary note examining this technology by new advisor and biofuels expert, John Sheehan, is available on the VG Energy website (www.vgenergy.net).
On January 3, 2011, Viral Genetics settled the nearly 5 year-old lawsuit that was before the U. S. District Court for the Northern District of Illinois (No. 06 C 1813) regarding the Company's previous efforts in South Africa. This settlement frees up management time and Company resources that were previously consumed by the expensive litigation process and it allows Viral Genetics to continue the pursuit of the registration of an HIV/AIDS drug in Africa – the single largest potential market for such a product. See the Company's January 28, 2011 press release for more information.
Enhanced Advisory Board
Several notable advisors joined Viral Genetics' Board of Advisors in 2010, including Nobel Laureate Baruch S. Blumberg, MD, Ph.D. and biofuels expert John Sheehan. Dr. Blumberg is the discoverer of the Hepatitis B virus, and the inventor of the vaccine for it. The Company also retained two independent research firms, Zacks and Research 2.0 Partners, to research and write reports on the Company and its stock as a means of providing further exposure to Viral Genetics among the North American investment community.
About Viral Genetics, Inc.
San Marino, California-based Viral Genetics discovers drug therapies. Founded in 1994, the biotech company is researching treatments for HIV/AIDS, Lyme Disease, Strep, Staph and drug resistant tumors. A majority-owned subsidiary called VG Energy is dedicated to exploring biofuel and agricultural applications for one of the technologies in its licensed portfolio. For more information please visit www.viralgenetics.com.
About VG Energy, Inc.
VG Energy Inc. is an alternative energy and agricultural biotech company that is a majority-owned subsidiary of Viral Genetics Inc., a biotechnology company researching new treatments and methods of detection for diseases including cancer, HIV/AIDS and others. Using its Metabolic Disruption technology ("MDT"), Viral Genetics' cancer research led to discoveries with major consequences in a wide variety of other industries, including bio-fuel and vegetable oils. VG Energy Inc. holds the exclusive worldwide rights to the licensed MDT patents for us in the increase of production of various plant-derived oils from algae and seeds. Importantly, these pivotal discoveries promise to allow the biofuel industry to overcome its major obstacle in the area of production efficiency: namely an increase in production yields leading to feasible economic returns on investment allowing renewable biodiesel to be competitive with fossil fuels. For more information please visit www.vgenergy.net.
Viral Genetics' Researcher and Advisor Set to Share Award
Time for Lyme Will Honor Dr. M. Karen Newell Rogers and Mr. Richard Gerstner
SAN MARINO, Calif., Feb. 15, 2011 /PRNewswire/ -- Viral Genetics, Inc. (Pink Sheets: VRAL) announced today that lead researcher Dr. M. Karen Newell Rogers and Advisor Mr. Richard Gerstner will receive the Lauren F. Brooks Hope Award, presented by Time for Lyme, Inc. The award presentation is set for the Illusions of Lyme Gala, April 2, 2011, in Stamford, CT. Dr. Newell Rogers is being recognized for her research on Targeted Peptide treatment for Lyme Disease at the University of Colorado at Colorado Springs and Texas A&M University. Mr. Gerstner helped Dr. Newell Rogers to initiate research on a treatment for the disease and has supported her research with funding.
"We are very proud of Dr. Newell Rogers' work and appreciative of the support that Mr. Gerstner has provided," said Viral Genetics' CEO, Haig Keledjian. "This award is a confirmation that Dr. Newell Rogers' research into a treatment for Lyme Disease is showing results."
"I would like to personally thank Mr. Gerstner for his original gift," added Monica Ord, Viral Genetics' Senior Vice President for Corporate Development and Communications. "Since that day, and with the steadfast support of Tyme for Lyme, Dr. Newell Rogers has uncovered not only a promising treatment but new information about this disease that is invaluable. We have never had such a willingness of immediate support in any other disease as with the Lyme community. We applaud you."
Dr. Newell Rogers and Viral Genetics are now completing the development of a molecule for the treatment of Lyme disease. This molecule is comparable to the Company's APi1177 Targeted Peptide molecule being studied for HIV/AIDS, which appears to rely on a similar underlying mechanism to assist in the control of chronic inflammation believed to be responsible for certain symptoms of Lyme Disease. Preliminary animal studies of this compound showed positive results in decreasing levels of inflammation in Borrelia infection in animals. Viral Genetics' goal is to initiate review of this drug candidate by the United States Food and Drug Administration through a pre-IND filing in 2011. Dr. Newell Rogers' research has been funded, in part, by grants from Time for Lyme, Inc., Mr. Richard Gerstner, and funding from Turn the Corner Foundation.
M. Karen Newell Rogers, Ph.D., is currently the Raleigh R. White Jr. Endowed Professor of Surgical Research at Scott and White Hospital's Department of Surgery, affiliated with Texas A&M University Health Science Center's College of Medicine, located in Temple, Texas. She was previously at the University of Colorado at Colorado Springs, where she began her research into Lyme Disease.
Richard T. Gerstner serves on the Advisory Board of Viral Genetics and is also on the Advisory Committee to Columbia University's Lyme and Tick Borne Diseases Research Center. He has served in executive management in numerous technology companies, including IBM and Telular Corporation.
About Viral Genetics, Inc.
San Marino, California-based Viral Genetics discovers drug therapies. Founded in 1994, the biotech company is researching treatments for HIV/AIDS, Lyme Disease, Strep, Staph and drug resistant tumors. A majority-owned subsidiary called VG Energy (www.vgenergy.net) is dedicated to exploring biofuel and agricultural applications for one of the technologies in its licensed portfolio. Online at www.viralgenetics.com
About Time for Lyme
Time For Lyme, Inc. (TFL), formerly The Greenwich Lyme Disease Task Force, is a 501(c)(3), all volunteer, nonprofit organization, and an affiliate of the national Lyme Disease Association (LDA). The organization promotes education about tick-borne illness, including detection, prevention, and advocacy for students and families. Online at www.timeforlyme.org.
"The work being undertaken by VG Energy is showing great promise as a viable and cost effective alternative energy source," said Viral Genetics' CEO, Haig Keledjian. "This report by Mr. Sheehan helps to point the way forward for us, and the coverage from EnergyBoom.com indicates that we are making progress and garnering attention from industry. Our next steps are focused on moving from the laboratory to a production setting."
Mr. Sheehan's report indicates that VG Energy's proprietary technology has the potential to create algal biofuel at prices that are competitive with current prices for crude oil. The process that VG Energy and its lead researcher, Dr. M. Karen Newell Rogers, are using could potentially lower the cost for algal oil production by significant amounts, making it comparable with conventional oil. This process results in increased lipid production in the algae cells as well as increasing the ability to recycle these cells. The report models several different production techniques currently in use with their productivity enhanced by use of VG Energy's compounds through increased lipid production and recyclability, showing a range of prices at which algae oil can be produced. VG Energy is planning studies to demonstrate these yields in practice. Mr. Sheehan is currently the Biofuels Coordinator in the Institute on the Environment at the University of Minnesota, and was previously a project manager at the National Renewable Energy Laboratory in Golden, CO.
The process that VG Energy uses to boost algal oil production is a direct result of work undertaken by Dr. Newell Rogers for cancer treatment. This process, called Metabolic Disruption Technology (MDT), is meant to disrupt cancer cells' ability to burn fat reserves, making them more susceptible to traditional treatments. The same technology appears to also act as a long sought lipid trigger to cause algae cells to store increased fat, making them more productive as an energy source. When the process was applied to algae cells in the lab, extractable lipid, or fat, production was increased by a minimum of 300%. Additionally, the process enables the cells to release fats outside the cell walls, making much of the algae recyclable. The combination of increased lipid production and recyclability appears to make algae economical as a source for a potential biofuel. Dr. Newell Rogers, the Raleigh R. White, Jr. Endowed Professor of Surgical Research at Texas A&M Health Sciences Center and Scott and White Hospital in Temple, Texas, is continuing her research into biofuel technology.
About VG Energy
VG Energy Inc. is an alternative energy and agricultural biotech company that is a majority-owned subsidiary of Viral Genetics Inc., a biotechnology company researching new treatments and methods of detection for diseases including cancer, HIV/AIDS and others. Using its Metabolic Disruption Technology ("MDT"), Viral Genetics' cancer research led to discoveries with major consequences in a wide variety of other industries, including bio-fuel and vegetable oils. VG Energy Inc. holds the exclusive worldwide license to the MDT patent rights for use in the increase of production of various plant-derived oils from algae and seeds. Importantly, these pivotal discoveries promise to allow the biofuel industry to overcome its major obstacle in the area of production efficiency: namely an increase in production yields leading to feasible economic returns on investment allowing renewable biodiesel to be competitive with fossil fuels. For more information please visit jttp://www.vgenergy.net
About Viral Genetics, Inc.
San Marino, California-based Viral Genetics discovers drug therapies. Founded in 1994, the biotech company is researching treatments for HIV/AIDS, Lyme Disease, Strep, Staph and drug resistant tumors. A majority-owned subsidiary called VG Energy (www.vgenergy.net) is dedicated to exploring biofuel and agricultural applications for one of the technologies in its licensed portfolio. Online at http://www.viralgenetics.com
Biofuels, Finance Algal Fuel: VG Energy Study Shows Price Parity Possible with Conventional Oil By Mitchell Anderson on March 7, 2011
Proprietary technology owned by VG Energy could create algal biofuel at costs competitive with current prices for conventional crude according to a report released by the company this week.
The study was authored by John Sheehan, former project manager at the National Renewable Energy Laboratory and currently the Biofuels Coordinator in the Institute on the Environment at the University of Minnesota. Sheehan also serves on the technical advisory board of VG Energy, a majority owned subsidiary of biotech start-up Viral Genetics (VRAL).
His projections are based on existing industrial processes and early lab results from VG Energy that indicate algae-derived diesel and jet fuel substitutes could be produced at prices competitive with conventional oil at $94 per barrel. This potential price breakthrough comes as world oil prices are spiking well beyond $100 and conventional producers are intimating that world supplies will be squeezed for the foreseeable future.
According to the study:
The introduction of VG Energy’s additives offers the ability to knock down the cost of algal oil production by almost a factor of ten as a result of productivity improvements. If oil secretion currently observed in the lab can be fully demonstrated in larger scale growth systems, there is a potential for further decreasing costs by another factor of roughly two. These represent dramatic changes in the economics of algae technology, and are truly game-changing. A lot of work remains to be done to establish the robustness of the VG Energy’s lab results, but these preliminary economic analyses show that the promise of the technology warrants further investment and investigation.
The long sought after technique to boost algae oil production has an unlikely origin. Viral Genetics researcher Dr. Karen Newell has been developing novel techniques to disrupt tumor metabolism to prevent them from burning fat reserves, making them more susceptible to chemotherapy and radiation.
This same metabolic switch appears to be the elusive lipid trigger that algal biofuel researchers have been seeking since the 1990’s that forces algae to store energy as fat rather than carbohydrates or protein.
When these trace chemical amendments developed by Viral Genetics to fight cancer were added to algae cultures in the lab, they were found to increase extractable lipid production by more than 300%.
“What they have stumbled on indirectly through a fairly unrelated field of research is the possibility that you really can turn on lipid production in algae,” said Sheehan. “For the last five years of the research at the National Renewable Energy Lab, we were entirely focused on exactly this question.”
Algae is attractive for biofuels due to their ability to grow much more quickly than terrestrial crops because they are very simple organisms. The problem is that algae tend to only want to produce the oil when they are stressed or believe they are in a scarce environment.
According to Sheehan, “algal biofuel researchers have been looking for the so-called ‘lipid trigger’ for over a decade. Our goal was to find a way to promote storing of organic carbon in algae in the form of oil, and that is what Karen Newell has appeared to have stumbled on.”
VG Energy’s techniques also cause algae to release fats outside of their tough cell walls creating the potential to recycle algal biomass without destructively extracting the oil. Sheehan feels that a 75% biomass recycle rate is possible, contributing to greatly reduced production cost projections.
Along with the enormous potential market to create economic biofuels, VG Energy’s technique could also create high value nutritional oils such as omega 3 fats at approximately one quarter the price of conventional sources. This market, while far smaller than transportation fuels, is still worth about $1.4 billion annually and growing at 10% per year.
Sheehan, who has been a leading expert in this algal biofuel research for more than fifteen years says that he is “cautiously excited” about the potential price breakthrough, but stresses that much must happen before you can economically fill up your tank with fuel refined from algae.
“VG Energy has made a really interesting discovery but a lot of work remains to turn this into a viable commercial process.”
VG Energy Contracts BioProcess Algae To Verify ''Lipid Trigger'' Results For Commercial Biofuels Production BY PR Newswire — 11:09 AM ET 03/25/2011 SAN MARINO, Calif. March 25, 2011 /PRNewswire/ -- VG Energy, a subsidiary of Viral Genetics, Inc. (VRAL) , announced today that it has retained alternative energy producer BioProcess Algae, LLC to verify lab results on a large scale for the development of commercial production of its potential biofuel process. VG Energy has developed proprietary technology, with results reproduced multiple times from test-tube to small-pond studies, which holds promise in producing algal biofuel on a commercial scale, at prices competitive with or better than current oil prices. "VG Energy's technology has shown great promise as a viable and cost-effective additive for alternative energy sources," said Haig Keledjian, CEO of VG Energy and Viral Genetics (VRAL). "We are thrilled to be working with BioProcess Algae to take the next steps and move from the laboratory to a viable production setting." The agreement came together quickly and was facilitated by VG Energy SVP Monica Ord. "I have Richard Branson and Mike Willis from Virgin Green to thank for the introduction to Green Plains Renewable Energy (GPRE) and BioProcess Algae," said Ord. "We have repeated our proof of principle research studies multiple times, internally and through Texas A&M, which have clearly demonstrated the effectiveness of the compound on a small scale. BioProcess Algae gives us the ability to move quickly into full autotrophic, mixotrophic and heterotrophic scale-up studies, and we are excited to begin." A process increasing lipid production in algae cells and considerably improving their rate of recyclability has been discovered by VG Energy and its lead researcher, Dr. M. Karen Newell Rogers, the Raleigh R. White, Jr. Endowed Professor of Surgical Research at Texas A&M Health Sciences Center and Scott and White Hospital in Temple, Texas. A recent report by biofuels expert John Sheehan models several current production techniques, with their productivity enhanced by VG Energy's process, with the results showing potential for a cost-effective energy source. A direct result of work undertaken by Dr. Newell Rogers for cancer treatment, this process, Metabolic Disruption Technology (MDT), appears to act as a long-sought lipid trigger to cause algae cells to store increased fat, making them more productive as an energy source. When the process was applied to algae cells in the lab, extractable lipid, or fat, production was increased by a minimum of 300%. Additionally, the process enables cells to release fats outside the cell walls, making much of the algae recyclable and increases its viability as an alternative energy source.
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