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Sunday, 07/12/2009 9:01:38 AM

Sunday, July 12, 2009 9:01:38 AM

Post# of 345554
7-11-09 Dr. Thorpe Interview on Bavi-AV in BMED Report

“An Interview with Philip Thorpe, Lead Researcher of the Recent Bavituximab Study”
July 11, 2009 / By Chris Fisher - The Behavioral Medicine Report (BMED)
http://www.bmedreport.com/archives/4486

Dr. Philip Thorpe, Ph.D., lead researcher of the Bavituximab study* [*Soares, M., King, S., & Thorpe, P. (2008). ’Targeting Inside-Out Phosphatidylserine as a Therapeutic Strategy for Viral Diseases’ - Nature Medicine, Dec.2008 1357-1362 http://tinyurl.com/9ktvsb ] reviewed on this website, recently agreed to conduct an interview with The Behavioral Medicine Report. The original review of his research [ 5-21-09, “One Step Closer to Antiviral Treatments for Persons Infected With Latent Viruses” http://tinyurl.com/lmzuqs ] turned out to be a highly accessed article that justified a follow-up interview with Dr. Thorpe. I also wanted to clarify my understanding of Bavituximab and its treatment implications and to better determine if the excitement that surrounds Bavituximab is justified.

I began the interview with a brief overview of my interest in Dr. Thorpe’s anti-viral research. In short, Dr. Roulette Smith’s viral theory of mental & physical health profoundly changed how I conceptualize psychological & developmental disorders. Dr. Smith hypothesizes that the Epstein Bar virus and its mRNA particles cause varying degrees of havoc on the human body that can result in pathological conditions, such as Autism and schizophrenia. If you accept Dr. Smith’s theory, then the next logical step is to identify ways to combat viruses and their virions in an effort to limit the incidence of these sometimes devastating disorders. I reasoned that Dr. Thorpe’s work may be the first step toward a real world effective treatment (i.e., beyond suppression therapy) for these latent viruses.

The following is a summary of my interview of Dr. Thorpe, along with a few personal thoughts & comments:

Question: Can you tell me more about Bavituximab?
Dr. Thorpe explained that Bavituximab is an antibody – or more concisely a protein produced by the immune system – that binds to a flipped cellular phospholipid, called phosphatidylserine. He went on to state that when cells are activated or stressed they expose their phosphatidylserine. This occurs on cells that line blood vessels inside tumors and on virally infected cells. Bavituximab binds to the phosphatidylserine and helps the immune system recognize the diseased cells. These actions then trigger an immune system response that clears the virally infected cells and their infectious virions. Dr. Thorpe’s study further demonstrates that the addition of traditional anti-viral drugs further facilitates the removal of these viruses, at least in guinea pigs and mice.

Question: How did you become involved with Bavituximab research?
Dr. Thorpe recalled that his original goal was to develop Bavituximab for the treatment of cancer. Along the way, he realized that it may also be an effective anti-viral drug. At this point, Dr. Thorpe recruited Dr. Melina Soares with whom he collaborated on the Nature Medicine study being discussed today.

Question: In light of the high incidence of latent viral-based diseases, do you think Bavituximab could be the answer to treating these seemingly incurable sicknesses?
Dr. Thorpe explained that viral drug resistance is a huge problem for conventional anti-viral drugs because the viruses rapidly mutate to acquire new properties that render them drug resistant. Bavituximab is a conceptually new drug that works in a way that makes viral drug resistance less likely. Bavituximab acts on the infected host cell itself rather than on the virus. Because the host cell is genetically stable, resistance may not develop. He believes that his Bavituximab study will redirect scientists’ attention on developing other drugs that exploit characteristics of infected host cells and believes this constitutes one of the most important aspects of his research. He also added that Bavituximab is considered a prototype that will be followed up with more refined (e.g. fully human) variants of the drug. Newer versions of Bavituximab are expected to have improved anti-viral activity.

Question: Do all latent viruses trigger exposure of phosphatidylserine?
Dr. Thorpe stated that the active (i.e., viral replication) phase always appears to triggers exposure of phosphatidylserine, but that it is currently unknown whether cells in which the virus has become dormant, or ‘latent’, will continue to have exposed phosphatidylserine.

Question: Regarding your specific study, any idea why you didn’t get a 100% cure rate when combined with anti-viral therapy?
Dr. Thorpe answered that this remains unclear at this point. He added that one possibility is that guinea pigs are not inbred like mice (i.e., increased genetic variability) and that this is area for further study.

Question: Is Bavituximab safe for humans? Could Bavituximab induce an auto-immune disorder? Can it pass the brain-blood-barrier (BBB)?
Dr. Thorpe reported that Bavituximab treatment appears to be well tolerated with few side effects. He also said that there has been no evidence of an autoimmune reaction in the many patients who have received treatment. He said it is not known whether Bavituximab crosses the BBB , but that he would not be surprised if it does not.

Question: Where is Bavituximab with the FDA process? Should Bavituximab be “fast tracked” through the FDA process in light of the millions of people who are sick and dying from viral-based diseases?
Dr. Thorpe described two ongoing phase 1 clinical trials – one with Hepatitis C [obviously in error – the Ph.1 Bavi-Mono/HepC/Repeat-Dose trial comp. 1-2007], and another with Hepatitis C & HIV. In regard to “fast-tracking” the drug, Dr. Thorpe hopes that the FDA will adopt this attitude.

Question: Have you conducted additional Bavituximab studies with any of the viruses mentioned in the Nature Medicine article or with the herpes (oral/genital) and Epstein Bar (EBV) viruses?
Dr. Thorpe reported that Bavituximab has now been tested with HIV in collaboration with Dr. Barton Haynes and colleagues at Duke Univ. Medical Center. He stated that they found that several antibodies which recognize phosphatidylserine can control HIV proliferation in cultured cells and can control multiple clades of HIV – adding that this is a very big finding. Dr. Thorpe further responded that Bavituximab has not been studied with genital or oral herpes or EBV. Also, he said that it is not known whether cells infected with viruses like these which can become latent will continue to have exposed phosphatidylserine. He went on to state that this may not matter because the current thought is that you might be able to deplete the pool of virus during the active phase of infection and if the latent pool of virus can not be replenished then it will die out.

Question: How long until Bavituximab is available for public use? Is this something that will be available in the foreseeable future?
Dr. Thorpe politely declined to discuss time frames.

WRAP UP AND FINAL THOUGHTS:
Bavituximab certainly appears to be a promising treatment for latent viral-based diseases once thought to be incurable. Obviously, additional human studies are needed to determine the effectiveness of Bavituximab. Dr. Thorpe’s research raises several important personal questions: Assuming that Bavituximab is found safe for humans and knowing that a large percentage of the United State’s population are infected with various latent viruses, should all persons receive a lifetime prescription for Bavituxmab to reduce or eliminate current and future exposure to certain latent viruses? Additionally, similar to a vaccine, can some or all childhood viral-based illnesses be prevented if given Bavituximab early on? Another interesting line of thought involves Dr. Smith’s belief that Autism may begin in the womb due to the mother’s EBV autovirions infecting her unborn child. If this is true, can the incidence of Autism be reduced if all pregnant mothers were placed on a combined Bavituximab and anti-viral drug regimen?

Hopefully future research will answer these important questions. A personal opinion is that Bavituximab and its future derivatives have the potential to profoundly change the course of human disease and suffering. Let us hope that I am correct because the human species has not faired well against latent viruses as evidenced by the high rate of, for example, HIV/AIDS, herpes, and EBV infections.

Dr. Thorpe is truly a gentleman and a scholar, and I thank him for the interview opportunity. Keep up the great work Dr. Thorpe!

Enjoy.
CFisher

Reference:
*Soares, M., King, S., & Thorpe, P. (2008). “Targeting Inside-out Phosphatidylserine as a Therapeutic Strategy for Viral Diseases”, Nature Medicine, 14(12), December, 1357-1362.
See: http://tinyurl.com/9ktvsb

= = = =
CHRISTOPHER FISHER, M.A., Managing Editor for The Behavioral Medicine Report, is currently a 4th year doctoral student in Clinical Health Psychology & Behavioral Medicine at the Univ. of North Texas (UNT-Denton), and senior staff & technical coordinator at the UNT Neurotherapy Lab. Chris’ doctoral program is unique in its multidisciplinary approach. In addition to traditional clinical psychology courses, students study health psychology, pharmacology, physiology, applied behavioral analysis, biofeedback, and other topics… He received a master’s degree in Clinical Psychology from Texas A&M-Corpus Christi in 2005.
http://www.bmedreport.com/bmed-user-community/user/cfisher

= = = = = Prev. Article on Dr. Thorpe’s Anti-Viral Work:
“One Step Closer To Antiviral Treatments for Persons Infected With Latent Viruses”
May 21, 2009 / By Chris Fisher - The Behavioral Medicine Report
http://www.bmedreport.com/archives/3401
Latent viruses and their damaging effects and possible cures are an intense focus of current research efforts. I not aware of any cure for these elusive latent viruses, who are virtually undetectable by the immune system during latent stages. Examples of latent viruses include herpes, Epstein Bar, and Cytomegalovirus. Latent viruses are suspected, and occasionally proven, to be casual or contributing factors to mental/developmental disorders, such as autism and schizophrenia and to physical disorders like high blood pressure and atherosclerosis (see the first link). Antiviral suppression therapy is the best treatment currently available. In today’s review, researchers* may have taken a important step toward the development of a potential cure for latent viruses. Links to Wikipedia are provided for several uncommon (at least in psychology) terms and medications.

In the current study, researchers hypothesized that cells infected with latent viruses would express their normally intracellular phosphatidylserine or “phospholipids” on the outer cell surface (”turn inside out”); thus, providing a potential target for therapy. Guinea pigs were infected with the deadly (to these animals) Pichinde virus, whose effects are very similar to Lassa fever in humans, and consistent with predictions, phospholipids emerged on cell surfaces within 6 hours. The guinea pigs were then given specific chimeric antibodies, called bavituximab, during advanced, lethal stages of the Pichinde viral infection. The results were amazing. Bavituximab not only bound to cells infected with the Pichinde virus, but also to their infectious virions. 50% of these animals recovered while 100% of the control group died. By day 135, no traces of the Pichinde virus were found in the animals. The researchers acknowledged this to be the first known successful treatment of advanced Pichinde viral infection. Combined therapy of Bavituximab plus the antiviral drug Ribavirin lead to a 63% treatment success rate. Moreover, cells infected with influenza A, vaccinia, vesicular stomatitis virus (VSV), and mouse cytomegalovirus (mCMV) viruses also responded to the bavituximab binding. Similar results were achieved in mice who been given lethal levels of mCMC and then bavituximab.

In terms of side effects, researchers stated that, “Bavituximab therapy seems to be well tolerated”. Treated animals retained normal body weight, appetite, appearance and physical activity (data not shown). No evidence of toxicity was visible histologically (data not shown). Coagulation parameters remained within the normal range” (pg. 1359).

Pretty amazing stuff. Scientists are slowly but surely learning how to root out these devious viruses, at least in animals. I hope that similar type of treatments can used with in human subjects with major public health viral-based diseases, such as HIV/AIDS and herpes. Latent viruses may play a much larger role in physical and emotional health than we currently understand, and my hope is that these new research findings will translate into real world anti-viral treatments, possibly cures, for humans. This study certainly puts us one step closer to this goal.

Reference:
*Soares, M., King, S., & Thorpe, P. (2008). “Targeting Inside-out Phosphatidylserine as a Therapeutic Strategy for Viral Diseases”, Nature Medicine, 14(12), December, 1357-1362.
See: http://tinyurl.com/9ktvsb
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