Viral Genetics, Inc - Spotlight Company Wiki
Viral Genetics
Viral Genetics, Inc. (VRAL) 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.
Company Overview
- Company Overview
- VGV-1
- The Science
- Drug Timeline
- Clinical Trials
- Executive Team
- Haig Keledjian
- Monica Ord
- Karen Newell
- Bada Pharisi
- Advisory Board
- Luc Montagnier
- Charles Everett Koop
- Eric S. Rosenberg
- Marshall C. Phelps, Jr.
- Richard T. Gerstner
- Anthony Freda, Jr.
- Sam Golube
- HIV Trends
- ARVs and IBTs
- Why We Need IBTs
- What Kinds of Immune-Based Therapies Are Being Studied?
- Thymus Nuclear Proteins
Viral Genetics, Inc. (VRAL) is committed to pursuing the development of thymus nuclear protein for a wide spectrum of diseases, and is currently focused on demonstrating the potential of the injectable VGV-1 drug for the treatment of HIV/AIDS and other auto-immune diseases. Preliminary indications from the company’s South African Phase III trial indicate that VGV-1 worked best in patients with low CD-4 counts. A technology license recently acquired from the University of Colorado may allow the company to accelerate the optimization of VGV-1 for its next clinical trials.
The company’s focus on TNP technology is promising, not only in the realm of treating HIV infection and AIDS, but in the possible use for other illnesses. During and after the company’s 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, Lyme’s Disease, and others, reported anecdotal improvements in the symptoms of these other illnesses. As part of the company’s future development of immune-based therapies, Viral Genetics intends to explore options associated with these areas.
VGV-1
VGV-1 is an injectable therapy based on Thymus Nuclear Protein (TNP) that is extracted from bovine thymus tissue. It consists of TNP suspended in adjuvant and is administered through 16 intra-muscular injections over an eight-week period. As a type of immune-based therapy, it focuses on boosting the immune system to allow the body to fight HIV more efficiently. Thymus nuclear protein technology has been studied in five human clinical trials for the treatment of HIV infection and AIDS.
The Science
More than twenty antiretroviral drugs have been approved for treating HIV, yet there is still a great demand for additional options. New AIDS drugs are most urgently needed for people who have had to abandon existing products due to drug resistance or side effects. For this group, access to a new medication can mean the difference between life and death. More generally, new antiretrovirals can bring benefits such as fewer side effects, less frequent dosing and a lower risk of drug resistance.
There are two kinds of therapy for illness: therapies that attack pathogens directly (viruses, germs and bacteria) and those that help the human body’s natural defenses eliminate pathogens more effectively. On occasion, both therapies are used to compensate or deal with the damage done by the pathogens.
VGV-1 is an injectable drug consisting of thymus nuclear protein suspended in adjuvant that is administered through 16 intra-muscular injections over an eight-week period. Outside the United States, there have been five human clinical trials with HIV infected individuals with varying viral load and CD4 levels. These studies suggest that VGV-1 is well tolerated and associated with decreasing viral load.
The current approach to HIV/AIDS therapeutics involves antiretroviral drugs. While these drugs are effective at controlling the levels of virus and prolonging life, but they do carry significant side effects, have complex dosing regimens, are usually quite expensive, and require daily ingestion of pills indefinitely. All drugs approved for treatment of HIV infection work by directly affecting the virus itself, whether its reproductive cycle or its ability to enter the immune system cells it hijacks in order to propagate.
Unlike other HIV/AIDS treatments, VGV-1 appears to have minimal side effects, an apparent immunological mechanism, minimal compliance issues, and is projected to be cost-effective. Because a treatment cycle with VGV-1 consists of just 16 injections, it is substantially less expensive than ART or HAART which require that drugs be taken once a day, or even more frequently. VGV-1 also works through a mechanism that involves the use of the immune system, rather than attacking the virus itself.
Executive Team
Haig Keledjian
Mr. Keledjian has been instrumental in guiding the growth and development of Viral Genetics, Inc., having acted as its Chairman, Chief Executive Officer and President since its 1995 founding. He has overseen the completion of VGV-1’s five human clinical trials, including the recently completed Phase III trial in South Africa, the creation of Viral Genetics’ global intellectual property portfolio and the financing of Viral Genetics.
Monica Ord
Ms. Ord has been involved in the life sciences industry for over 17 years, including as an entrepreneur with her own health promotion and marketing company, and as an international sales manager for two Fortune 500 companies. She has been active in venture capital and financial consulting with public companies for over 9 years and also has extensive experience in recruitment of high-level executives, advisory board members, and directors in the healthcare industry.
Ms. Ord also is active in the entertainment industry where she excels in sourcing finance for global crises project. She is currently a partner in Paradise FX and owner of Arctica Films, both based in California. She recently partnered with Sir Richard Branson and was executive producer of Global Warming 101 Expedition, Baffin Island '07: “Bear Witness”, a feature-length documentary that followed Sir Richard Branson, his son Sam Branson, and legendary explorer Will Steiger through a 1,200-mile Arctic dogsled journey chronicling the effects of climate change on the native peoples and the environment.
Karen Newell
Dr. Newell is Associate Professor in the Department of Biology at the University of Colorado, Scientific Director of the CU Institute of Bioenergetics, the Clement and Margaret Markert Endowed Professor of Biology, Associate Director, Center for Computational Biology, and Adjunct Assistant Professor at Dartmouth Medical College. She has authored or co-authored several dozen peer-reviewed papers predominantly focused on immunology and cellular metabolism, and she has over 30 issued or pending patents.
Bada Pharisi
Bada Pharasi is an experienced senior manager in the pharmaceutical industry with a track record of both private and public sector positions. While a civil servant, he was instrumental in the development of several national drug policy initiatives. Mr. Pharasi serves as a senior advisor with the “Rational Pharmaceutical Plan Plus” project, a program funded by USAID as part of the President’s Emergency Plan for AIDS Relief. This project is aimed at improving the use and availability of drugs, vaccines, and supplies in the public health sector. Mr. Pharasi also has extensive experience in the drug regulatory environment of South Africa, having served as Chief Director of Registration, Regulation and Procurement for the Department of Health, where he was responsible for policy development, implementation, budgeting and supervision including oversight of the Medicines Administration. The Medicines Administration is a support agency to the Medicines Control Council (the primary drug regulator in South Africa) and administers the Medicines and Relates Substances Control Act. Mr. Pharasi previously worked with Viral Genetics South Africa, the Company’s former distributor in South Africa.
Advisory Board
Luc Montagnier
Dr. Montagnier is best known for his 1983 discovery of the human immunodeficiency virus (HIV), which has been identified as the cause of AIDS. This discovery led directly to the development of a test for detecting the presence of HIV in blood samples. He has received more than 20 major awards, including the Commandeur de la Legion d'Honneur, the Lasker Award, the Gairdner Award, King Faisal Foundation International Prize(known as the Arab Nobel Prize),and this year's Nobel Prize in Physiology or Medicine awarded to him for the discovery of HIV.
He is the co-founder of the World Foundation for AIDS Research and Prevention and co-directs the Program for International Viral Collaboration. As President of the World Foundation for Aids Research and Prevention, he has co-founded two centers for the prevention, treatment, research and diagnosis of AIDS patients in Ivory Coast and Cameroon.
Charles Everett Koop
Charles Everett Koop was born in Brooklyn, New York on October 14, 1916. He obtained his B.A. degree from Dartmouth College in 1937 and his M.D. degree from Cornell Medical School in 1941. After interning at the Pennsylvania Hospital, Dr. Koop pursued postgraduate training at the University Of Pennsylvania School Of Medicine, Boston Children’s Hospital and the Graduate School of Medicine at U. of Pennsylvania, where he obtained a D.Sc. Degree in 1947.
At U. of Penn., Dr. Koop was appointed professor of pediatric surgery in 1959 and then also received a professorship in the department of pediatrics. From 1948 to 1981, Dr. Koop was also Surgeon-in-Chief at the Children’s Hospital of Philadelphia where he was a pioneer in pediatric surgery. He structured an internationally renowned department that established the first neonatal intensive care nursery and was a founder of the American Academy of Pediatric Surgeons.
In February 1981, President Reagan appointed Dr. Koop as Deputy Assistant Secretary for Health. On January 1982, when he was sworn in by the Senate as U.S. Surgeon General, AIDS was a deadly enigma. At the direct request of President Reagan in 1986, Dr. Koop prepared the first national report on AIDS. This explicit, nonjudgmental and monumental document contributed significantly to providing the first accurate and comprehensive information on AIDS. In 1988, Dr. Koop wrote "Understanding AIDS," a Public Heath Service brochure based on CDC guidelines, which was sent to all 107 million households in the U.S. It was the largest mailing ever by the federal government.
“Dr. Koop’s treatment of HIV / AIDS as a public health issue rather than a moral issue was a major breakthrough. The report and mailing educated the public on the magnitude of the epidemic, which garnered support for new research and methods of treatment,” said Monica Ord, SVP of corporate development and communications for Viral Genetics, Inc.
In October 1989, he resigned from office, but his highly regarded leadership on public health topics such as tobacco, organ transplantation, AIDS and the rights of the disabled left the Office of Surgeon General more esteemed than ever before. He has relentlessly continued to educate the public about health issues through his many writings and media appearances. Dr. Koop now serves as Senior Scholar of the C. Everett Koop Institute at Dartmouth Medical School and is a member of the governing boards of several nationally recognized health-related organizations.
Eric S. Rosenberg
Dr. Rosenberg has an extensive background studying HIV. He is best known for his research on early HIV infection, also known as primary HIV infection. His important findings of immune control of HIV infection during structured treatment interruptions in primary infection were previously published and highly cited in journals, including Science and Nature. Dr. Rosenberg is board-certified in Internal Medicine and Infectious Diseases. His research and clinical practice is focused on the immunopathogenesis of HIV infection with additional work related to infectious disease and transplant medicine. Dr. Rosenberg is an Assistant Professor of Medicine at Harvard Medical School, where he has been appointed in various academic capacities since 1995, and is a Staff Physician at the Massachusetts General Hospital in Boston, where he has also been appointed since 1995. He serves in the capacities of Associate Director of the Clinical Microbiology Laboratory, and Director of the Education Unit of the Clinical Research Program at Massachusetts General Hospital.
Dr. Rosenberg is a member of several professional societies and associations, editorial board member of the Journal of Immune-Based Therapies and Vaccines, and Associate Editor of AIDS Clinical Care. Dr. Rosenberg is Chair of the Treatment Working Group of the National Institutes of Health Acute Infection Early Disease Research Program, and a member of the Massachusetts General Hospital Clinical Research Council.
Dr. Rosenberg has been co-chair, co-principal investigator, and principal investigator of clinical trials focused on HIV treatment, and has been the beneficiary of several NIH awards. He is a regular presenter in the field of HIV infection and has published over 50 articles in the literature. Dr. Rosenberg obtained his MD from the Mount Sinai School of Medicine in New York and completed his internship, assistant residency and chief residency in Internal Medicine at the University of North Carolina.
Marshall C. Phelps, Jr.
Marshall C. Phelps, Jr. is currently Corporate Vice President for IP Policy and Strategy for Microsoft. In this position, Mr. Phelps is responsible for establishing global policy and strategy for Microsoft's intellectual property, and interfacing with governments and technology companies about intellectual property issues. During his tenure at Microsoft he has also overseen management of the company's trademark, copyright, patent, trade secret and related divisions. Prior to Microsoft, Mr. Phelps spent 28 years at IBM where he served as vice president for intellectual property and licensing. At IBM, Phelps oversaw the company's patent licensing program and intellectual property portfolio development amongst other things.
In between IBM and Microsoft, Mr. Phelps spent two years as chairman and chief executive officer of Spencer Trask Intellectual Capital Company LLC, which specialized in spin-offs from major corporations such as Motorola Inc., Lockheed Martin Corp. and IBM. Phelps holds a Bachelor of Arts degree from Muskingum College, a Master of Science degree from Stanford Graduate School of Business and a doctorate from Cornell Law School. He is an Executive-in-Residence at the Fuqua School of Business at Duke University, and also serves on the Board of Visitors. He has also recently been asked to advise Japan's Ministry of Economy, Trade and Industry on IP matters and was elected to the initial class of the Intellectual Property Hall of Fame, in 2006.
Richard T. Gerstner
Richard T. Gerstner joins Viral Genetics as an Advisor after a lifetime of executive management positions and investment in the technology arena. Gerstner spent several years as President and CEO of Telular Corporation, a wireless communication company he took public in the 1990s. Prior to that, he spent 32 years at IBM in several capacities including 10 years as a Corporate Vice President during which he served as Chief Planning Officer, Head of the Asia/Pacific region located in Tokyo and Group Executive of IBM Personal Computers, and most recently as head of IBM's PC Group.
He is a director of various technology companies and is Chairman of the Advisory Committee to the Columbia Lyme and Tick-Borne Disease Research Center. Mr. Gerstner holds a BS in Chemical Engineering from Villanova University and an MS in Industrial Engineering from Stanford University.
Anthony Freda, Jr.
Anthony Freda, Jr. comes to Viral Genetics after several decades in business development, engineering, and senior management roles. His career progressed from design engineering to management in the 1960s at Cutler Hammer, an electrical systems and engineering firm now owned by Eaton Corporation, a Fortune 500 electrical systems and engineering firm. While at Cutler Hammer, Mr. Freda ran the international systems business unit and was responsible for all aspects of the Air Traffic Control unit in 20 countries. He followed this with several corporate marketing positions at Telephonics Corp., a division of Griffon Corporation.
In the 1990s, Mr. Freda held several corporate management positions at Telephonics including staff VP for strategic alliances. At the time of his retirement in 1998 he was the General Manager of the Electronic systems division. Mr. Freda received BS and MS degrees in electrical engineering from Villanova University and Polytechnic University of NY in the 1960s. He did his graduate work in business under a Beloit College program.
Sam Golube
Dr. Gulube was appointed the National Medical Director of the South African National Blood Services in May 2006. He served as the Chief Executive Officer of the Universal Service Agency of South Africa from April 2003 to April 2006. During his term he turned that organization around introducing new projects such as Telecontainers and Community Digital Hubs (CDH) that have given the Universal Service Agency a new identity in under served communities it serves. From the year 2000 to 2003 he was the Director of the National Telemedicine Research Centre at the Medical Research Council (MRC) of South Africa. Under his leadership the MRC and the International Digital Partnership established the Telemedicine Testbed in the Mpumalanga Province of South Africa that serves as a Centre of Excellence in the introduction of Telemedicine in Southern Africa. Dr Gulube, MD, is also the Chairman of the Medical Panel of the Presidency of South Africa. He has held various positions with the Medical Research Council of South Africa and the National Department of Health, as well as appointments as a surgeon in the military and at the University of South Florida College of Medicine. Dr. Gulube received his MD from the Morehouse School of Medicine in 1991.
HIV Trends
To date, scientists have not been able to find a cure for HIV. What has been discovered are drugs that put the HIV virus on hold, offering many people longer, healthier lives. These drugs, called antiretrovirals (ARVs), also bring a variety of potential side effects some of which are difficult to live with and get worse over the years. Unfortunately, antiretroviral drugs can't cure HIV -- if you stop using them the virus comes back.
HIV is like herpes -- you can control it, but not get rid of it. Because of this, HIV scientists and activists are looking at a new goal for therapy -- how to get the body to control HIV without antiretroviral drugs.
ARVs and IBTs
A healthy immune system will get rid of or control most viruses by itself. When the immune system cannot do this alone, one way to help is to use chemicals that kill, weaken or stop viruses from making more viruses. In the case of HIV these drugs are called antiretrovirals because HIV is a "retrovirus."
Another way to help the body fight a virus is to boost the body's immune system. When scientists develop a therapy that helps the immune system fight a disease, we call it an "immune based therapy" or IBT.
Why We Need IBTs
We need immune-based therapies because antiretrovirals are not good enough. Antiretrovirals are great drugs, but they must be taken forever, on time, all the time. If you miss doses, they can stop working. And then there are the side effects. Some antiretrovirals make so much fat in your blood doctors are concerned that in the long run the drugs will cause heart attacks. Others antiretrovirals cause problems with your emotions or disturb your sleep with vivid nightmares. Some run the risk of allergic reactions that can be deadly. Many are very hard on the liver. Other antiretrovirals give you lipodystrophy -- making faces and buttocks skinny and bellies and breasts fat.
In addition to side effects, no one knows if the drugs can keep the virus down for a lifetime. And antiretrovirals are very expensive. These are the reasons scientists are looking at immune-based therapies for a less toxic, cost effective alternative.
What Kinds of Immune-Based Therapies Are Being Studied?
All immune-based therapies try to boost the immune system -- allowing your body to fight HIV more efficiently. Several immune-based therapies are being studied. Immune-based therapies vaccines are being tested to see if they can boost the immune system's ability to fight HIV.
Three vaccines have had some success. One is being studied in France, another one, called Remune, was tested in Spain and Merck is testing its version in the U.S. this year. It is clear, vaccines will play some role in helping us fight HIV.
Another effort going on is the use of certain chemicals the body produces and helps cells fight harder like IL-2 and IL-7. These chemicals are called cytokines. There is hope cytokines might help the body get rid of HIV altogether. The U.S. government is working on these studies.
In addition, antibodies have been discovered that help the body suppress HIV without drugs. These antibodies have been tested successfully in monkeys. If they work in people, long drug holidays may be possible. Why is this important? By giving people a "holiday" from taking their antiretroviral therapy, the body gets time to recover from drug toxicities.
Also, a very interesting extract taken from a cow, from a gland called the thymus, is being developed that looks like it helps the body get rid of a lot of HIV. This extract is being called thymus nuclear proteins or by it's initials: TNP.
Thymus Nuclear Proteins
Thymus nuclear proteins used in studies of HIV were developed by Viral Genetics, a small California biotech firm. They call their immune-based therapy "VGV-1."
An article about the viral genetics thymus extract was published in the journal HIV and AIDS Review in August of 2004. It explains that ten HIV-positive volunteers were given VGV-1 twice a week for two months along with their antiretroviral drugs. The volunteers were studied for six months. The volunteers had reportedly been failing their antiretroviral drugs and were on their second or third regimen.
Before these volunteers started taking VGV-1, they had quite a bit of virus. By three months, half the volunteers responded to VGV-1 and had undetectable amounts of virus. By six months, they had over 90% drop in the amount of virus. Most importantly this was months after these volunteers had stopped using VGV-1.
It is important to notice that before taking this version of thymus nuclear proteins, their antiviral cocktails were failing.
For more information and current press releases visit www.ViralGenetics.com