New Study Building off Viral Genetics' Research Aims to Unlock the Mysteries
behind Lyme Disease and Other Immune Based Diseases Including HIV/AIDS
Last update: 6:27 p.m. EDT Sept. 10, 2008
AZUSA, Calif., Sep 10, 2008 (BUSINESS WIRE) --
Viral Genetics, Inc. (Other OTC:VRAL), a biotechnology company that discovers and develops immune-based therapies, announced today it has completed an initial study that aims to unlock the mysteries behind Lyme Disease, which could also potentially offer answers to other immune-based diseases including HIV/AIDS.
In addition, a $25,000 gift has been awarded from an undisclosed source to further explore this new model in Lyme Disease through follow-on studies which researchers, including lead investigator Professor M. Karen Newell, PhD, Professor at the University of Colorado at Colorado Springs,
hope will serve to reconcile the long-standing and controversial debate in the medical community over treatment methods for Lyme Disease.
"Since the addition of Professor Karen Newell to our existing Harvard team and as a result of our recent promising studies with our new model in HIV/AIDS, we have found that the model has potential promise in Lyme Disease," said Monica Ord, SVP of corporate development and communications for Viral Genetics.
"Through the generosity of an undisclosed philanthropist, we will not only be answeringkey questions for Lyme Disease, but with this new data, the company will also be accelerating our ongoing studies in HIV/AIDS."
Lyme Disease and Testing Challenges Lyme is mainly found in the eastern United States with smaller risk areas on the west coast. It is caused by the transmission of the Borrelia burgdorferi spirochete via the bite of the blacklegged Ixodes tick. Additional species are found in Europe and northern Asia.
Lyme Disease has been reported in all 50 states with the highest incidence along the eastern seaboard, Wisconsin, Minnesota and northern California.
The CDC reports a 100% increase in cases of Lyme Disease in the U.S. from 1991-2006, while recognizing that at least ten times more cases may go unreported.
In 2005 alone, 23,305 cases were reported in the U.S.
Regardless of location, primary symptoms of Lyme Disease are characterized by persistent fatigue, chronic musculoskeletal pain, and subjective cognitive slowing.
Some authors refute the "chronic" label and instead attribute the symptoms to coincidence of the initial infection.
Lyme 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.
Current Methods of Treatment
Initial treatment of Lyme (regardless of stage) has been conventional antibiotics. Most cases caught early are cured by this treatment.
Chronic Lyme Disease is that which persists past the conventional antibiotic therapy. The earlier treatment starts, the greater the chances for a complete recovery, but the difficulty in diagnosis can delay treatment and treatment success.
The Controversy Over Treatment of Lyme Disease Research on chronic Lyme Disease, including symptoms related to the central nervous system and arthritis, has generated inconclusive and controversial results.
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 the disease is the result of autoimmune T-cell activation that occurs subsequent to the initial infection or after the infection has cleared.
"Our hopes are that the information acquired from this very important study, may act as a bridge between those who contend that Lyme Disease is an active chronic infection and those who feel it is an autoimmune trigger.
The answer to this question is of great importance for all those suffering in the Lyme community. Only through this information can we begin to formulate more successful treatment regimens for the chronically ill," said Dr. Steven Harris, co-investigator, Associate Professor Stanford University.
Study Aims to Unlock Mysteries, Reconcile Debate
The Viral Genetics proposal describes a potentially novel mechanism in which bacterial infection with the pathogen Borrelia burgdorfii activates the immune system.
The new model suggests that the nature of the immune response may be responsible for the pathology of the disease and that targeted peptide therapy has the potential to resolve disease symptoms.
"The model reconciles both the initial disease and accounts for the consequent processes that appear pathologically similar to autoimmune disease, whether the Borrelia organisms survive in the host or not," said Dr. Newell, lead investigator of the study team.
A Gift To Support Further Research
An undisclosed philanthropist has provided a $25,000 gift that will go towards additional research of this new model in Lyme Disease being conducted by Dr. Newell.
"We are so grateful for this gift," said Dr. Newell. "It will allow us to test this new model in initial 'proof of concept' experiments that relate infections with a kind of immune response that develops in certain people, in a genetically determined manner, that may lead to chronic, inflammatory disease.
The model provides a different perspective on how both the pathogen and the immune response may contribute to chronic disease instead of full recovery from infection."
Research in HIV/AIDS May Lead to Breakthrough in Lyme
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 Disease.
"This new model shows promise, and we look forward to what further research could potentially yield for the many thousands of people afflicted with this mysterious disease worldwide, and other immune-based diseases such as HIV/AIDS," 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 (~jvr: see below)
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.
Viral Genetics, Inc. is a biotechnology company that discovers and develops immune-based therapies for HIV and AIDS using its thymus nuclear protein compound.
This compound 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 VGV-1 represents a significant and unique approach to treating HIV due to the apparently novel mechanism, low toxicity profile, simple dosing regimen, and short-course of treatment.
Our management team, board and advisors include world-renowned experts in the fight against HIV/AIDS, infectious disease, and autoimmune deficiency.
Viral Genetics Announces Licensing Deal with University of Colorado and V-Clip Pharmaceuticals, Inc.
Viral Genetics Builds African Advisory Team. Viral Genetics, Inc. (OTCBB: VRAL) has retained two senior advisors as part of its African advisory team as the Company continues the development of VGV-1, the Company's HIV/AIDS product, in Africa.
Hoosiers51
Frequent Contributor (1K+ posts)
Member # 15759
posted
Thanks for posting this bettyg.
I read the whole article but didn't click on the links (hey, only so much I can handle at once....you know what i mean!)
I was really impressed with this article. Seems to offer hope for a treatment that is radically different than what we and the doctors who care for us are trying at this point.
I'm sure it's nothing to get our hopes up about yet, but it's a great step, and I'm excited to see what comes of it.
I wish I had $25,000 dollars to donate because that would double their money!!! Maybe if we do a lot of research into this, we at Lymenet could start to raise some of our own money to donate.
I would definitley want to know more about the company first though.
Thanks again for posting bettyg.
Posts: 4590 | From Midwest | Registered: Jun 2008
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posted
Interesting study. I'm a little confused though...it says Dr. H is involved in this study. Is this Dr. H associated with the lab or maybe the treating MD? If their study objectives are correct, it would support IDSA theory that we continue to be sick due to an autoimmune disorder versus persistent Bb.
Anyway, I totally support anything that will help us determine what is going on and ultimately find us maybe some relief.
Posts: 561 | From mass | Registered: Jul 2007
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posted
Thanks Betty for posting this vital report. I certainly believe they are on the right track as my introduction with Lyme was triggered by an occurrence I had at work(I had been required to work three twelve hour shift, followed by an 19 hour shift, which resulted in a massive breakdown of my immune system). I now am dealing with a total breakdown of my immune system once again due to inflammation of organs throughout. It seems as if it is a viscious cycle, as there has been a ten year lapse between occurrences. Multiple sensativities syndrome (MCS)and Lyme are closely connected, I believe.
-------------------- Else Posts: 82 | From Florida | Registered: Aug 2007
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bettyg
Unregistered
posted
above dr. harris talked about above is not llmd!
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Hoosiers51
Frequent Contributor (1K+ posts)
Member # 15759
posted
KS, It sounds initially like they are only talking about something for autoimmune disease, but if you read closely I think it is saying some of the people helped by this WOULD have chronic infections.
Here are a couple quotes followed by my interpretations:
"The model reconciles both the initial disease and accounts for the consequent processes that appear pathologically similar to autoimmune disease, whether the Borrelia organisms survive in the host or not," said Dr. Newell, lead investigator of the study team.
Thus, the borrelia may still be there, due to immune problems.
"The model provides a different perspective on how both the pathogen and the immune response may contribute to chronic disease instead of full recovery from infection."
Thus, the infection is still there. Not just autoimmune.
"TNP may have other potential applications for other infectious, autoimmune, and immunological deficiency diseases that the company intends to study in the future"
Notice the word "infectious."
Posts: 4590 | From Midwest | Registered: Jun 2008
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quote:above dr. harris talked about above is not llmd!
how can one be so sure?
Posts: 188 | From ID | Registered: Jan 2007
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oxygenbabe
Frequent Contributor (1K+ posts)
Member # 5831
posted
The model makes a lot of sense. Certain genetics, a disabling inflammatory/immune response somewhat crippling the immune system and leading to its own perpetual damaging elevated cytokines etc... If you could perhaps give these peptides whatever they are, with antibiotics again, maybe it would help. Maybe this explains why some people get over lyme quickly and others suffer endlessly, along with the fact that there is a virulent strain out there responsible for a lot of the worst cases. And maybe that virulent strain was engineered to create this inflammatory response.
Posts: 2276 | From united states | Registered: Jun 2004
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posted
I am all for more research, but don't think I will volunteer hubby as a research subject.
Peptide shots (basically proprietary amino acid shots) have been studied much more in foreign countries. I think France has done much of the advanced research. Also think most of the research has been aimed at cancer.
Hubby actually had 2 peptide shots in September and October I think of 2006. They raised his white blood count for only a couple of days. And unfortunately in January of 2007 he had a paralytic ileus which may have been caused by a virus. To be honest his health has never really been the same since.
At $250 per shot this was a big gamble that did not pay off.
I have heard of at least one other natural doc in the Northeast who claims to have had some success with peptide shots -- this info was given to me by another doc in December of 2007. Did not follow up on this though as hubby decided to pursue Bartonella treatment.
Supposedly this other doc was using a different formula peptide shot than those hubby previously received.
I think there are just too many unknowns regarding Lyme and the immune system for this research to be very promising. No one even seems to know if Lyme causes a Th1 or Th2 immune response.
And then the coinfections probably play a big part in the immune response also.
Bea Seibert
Posts: 7306 | From Martinsville,VA,USA | Registered: Oct 2004
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oxygenbabe
Frequent Contributor (1K+ posts)
Member # 5831
posted
I am not saying you should experiment on your husband. They should probably do animal studies first.
However, I know that that first summer of getting lyme, after a trial of doxycycline, and having all kinds of fibro and neck pain, I took cholestyramine. Unfortunately all that was available was a formula with sugar, and I already had an exacerbated fungal issue because of the recent antibiotics. However, one dose literally TOOK AWAY ALL MY PAIN and symptoms. I was amazed. For a few days it was a bit of a miracle (and no herxheimer, but again, this was early in lyme, the first few months). Unfortunately the sugar began to bother my bladder a lot and other yeast symptoms so I stopped.
A year or two later, I found a sugar-free formula. But then it had no effect.
This says to me that early in my reaction to lyme, I had an acute inflammatory response that may indeed have been specific to my genetics (I don't have any evidence that the family in whose garden I got it has had anything NEAR to the disaster I've experienced with lyme). The cholestyramine bound enough of the fat soluble toxins to shift the immune response instantly. Later, that response was entrenched, and cholestyramine had little effect.
This is congruent with info I remember from Pam Weintraub's book but I need to re-read it now. My recollection is that studies by Janet Wais showed that the inflammatory response to lyme was very genetically based--and varied accordingly.
I have never forgotten this and I think it was very meaningful. I'm interested in this research and if I get a break in time/schedule may call the scientific advisor, Newell.
Posts: 2276 | From united states | Registered: Jun 2004
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The point I was trying to make is that peptide shots is such a generic description that the research might or might not be valid.
Plus all the uncertainties regarding the immune system and how it responds to Lyme.
At the time hubby did the peptide shots we did not know he still had Bartonella or BLO and were somewhat desperate for another approach -- had tried many oral and IV antibiotics, oral and IV colloidal silver, many herbal protocols, oxidative therapies (IV hydrogen peroxide, IV blood ozone and IV UVB treatments), IV Phosphatidylcholine etc etc.
Just sharing hubby's experiences.
The doc who gave hubby the peptide shots was a general M.D. and not an LLMD. I think I would be much more impressed by the research from this company if they actually had an LLMD involved.
If they are only considering the Lyme arthritis model for example I think the research could be seriously flawed and of little benefit for many Lyme and tickborne patients.
Bea Seibert
Posts: 7306 | From Martinsville,VA,USA | Registered: Oct 2004
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oxygenbabe
Frequent Contributor (1K+ posts)
Member # 5831
posted
Bea,
There has got to be *some* reason that people need to take years of antibiotics and antimalarials. Yes there are coinfections and yes it occurs to me sometimes that some dastardly weapons scientist engineered a horrible soup of bugs to put in the tick. I tend to think its more likely that lyme alone was bioweaponized and that it is immune suppressive directly by the mechanism discussed above and *then* the co's get going and they're a big problem, too. Generally it is the immune response to pathogens that kills you, and generally that is genetically mediated.
It would explain better to me this crazy situation where you need so many rotating oral antibiotics and antimalarials. It just doesn't make sense to me and never did. I have also wondered if it was engineered with viral genes and for that reason persists, or if its a mycoplasma not borrelia and that's just an artifact....who knows.
Anyway I'd like to find out more. This peptide may or may not be a helpful adjunct *but* the line of thinking is good.
Posts: 2276 | From united states | Registered: Jun 2004
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sparkle7
Frequent Contributor (5K+ posts)
Member # 10397
posted
Thanks for posting this. I will have to look over the links in more detail later.
You always have to wonder about the potential profit motive of discovering new drugs. It makes me wonder when they list the stock exchange info of the company doing this research...
They should be paid for their work or any drugs they come up with but it seemed a bit obvious. I guess the info was from an economic website... maybe I'm being overly critical?
Posts: 7772 | From Northeast, again... | Registered: Oct 2006
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Angelica
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posted
The doctor listed above is a LLMD.
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