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LiSAVIOR

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INTERVIEW WITH DR. ROGER KENNETH HERSHLINE, FOUNDER AND CEO OF GLOBAL HUMANCEUTICALS, INC., DISCUSSING THEIR NEW DRUG LiSAVIOR : 

INTERVIEW WITH DR. ROGER KENNETH HERSHLINE, FOUNDER AND CEO OF GLOBAL HUMANCEUTICALS, INC., DISCUSSING THEIR NEW DRUG LiSAVIOR MAY 17, 2008

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THE USE OF LiSAVIOR FOR THE PREVENTION, TREATMENT AND CURE OF HIV INFECTION IN THE HUMAN

DR. Roger Kenneth Hershline PhD MDCEO, Global Humanceuticals, Inc., : 

DR. Roger Kenneth Hershline PhD MDCEO, Global Humanceuticals, Inc.,

Q: Dr. Hershline it is great to have you here today. What is HIV? A: HIV is believed to be the causative agent of AIDS. AIDS; Wikipedia, the free encyclopedia, 2008.

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Q: What is the problem? A: The most pressing problem existing today is that all vaccine attempts have failed to prevent this infection and all drug treatment attempts have failed to eradicate this disease. Belmonte, L., Olmos, M., Fanin, A., et. al.; The intestinal mucosa as a reservoir of HIV-1 infection after successful HAART. AIDS. 21(15):2106-8, October 1, 2007.

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Q: Why have there been so many failures? A: Mutation of the virus is thought to play a significant role in both vaccine and drug failures. Yates, Andrew; Stark, Jaroslav; Klein, Nigel; Antia, Rustom; Callard, Robin; Understanding the Slow Depletion of Memory CD4+ T Cells in HIV Infection; PLoS Medicine, May 2007 , Volume 4 , Issue 5, December 05, 2006.

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Q: How does HIV escape these medications? A: Clinical and experimental evidence of drug and vaccine failure indicates that there must be a reservoir in which HIV can be sequestered, mutate, multiply and then re-emerge.

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Q: Is there any objective findings that suggest that HIV infects the gastrointestinal tract? A: Currently, there is a body of growing evidence that HIV multiplies, mutates and overwhelms the gastrointestinal tract and it’s immune system early in HIV infection. This is now believed to result no-matter whether HIV is contracted sexually or thru contaminated needles. Mehandru, S., Tenner-Racz, K., Racz, P., Marcowitz, M.; The gastrointestinal tract is critical to the pathogenesis of acute HIV-1 infection; Journal of Allergy and Clinical Immunology, Volume 116, Number 2; pages 419-422; 2005. Douek, Daniel C.; The New York Course 2007: HIV pathogenesis – An expert interview with Dr. Daniel Douek; Medscape HIV/AIDS; May 10, 2007. Mehandru, Saurabh and Dandekar, Satya; Role of the gastrointestinal tract in establishing infection in primates and humans.; Current Opinions in HIV & AIDS. 3(1):22-27, January 2008. Dandekar, Satya; Pathogenesis of HIV in the gastrointestinal tract; Current HIV/AIDS Reports; Volume 4, Number 1, pages 10 -15, April 26, 2007. Brenchley JM, Schacker TW, Ruff LE,; CD4+ T cell depletion during all stages of HIV disease occurs predominantly in the gastrointestinal tract.; J Exp Med. 2004 Sep 20;200(6):749-59. Epub 2004 Sep 13.

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Q: How does the virus get to the gastrointestinal tract? A: It is proposed here that the life cycle of the evolved HIV particle passes from the serum in to the gastrointestinal tract and then back into the blood. Klenerman, Paul; Phillips, Rodney E,; Rinaldo, Charles R., et.al.; Cytotoxic T lymphocytes and viral turnover in HIV type 1 infection; Proc. Natl. Acad. Sci. USA ; Vol. 93, pp. 15323–15328, December 1996 Recapitulation Theory; Wikipedia.

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Q: What would be the consequences of such an HIV life cycle? A: This cycle provides a gastrointestinal tract or alimentary canal reservoir for HIV growth, multiplication and mutation presently not treated with current vaccines or medication. Mehandru, Saurabh. The Gastrointestinal Tract in HIV-1 Infection: Questions, Answers, and More Questions!, The PRN Notebook, Volume 12, December 2007, 1-10. Marle, Guido van; Gill, M. John; Kolodka, Dione; et.al. ; Compartmentalization of the gut viral reservoir in HIV-1 infected patients. Retrovirology, 4:87, December 4, 2007, 1 – 14.  Gendelman, Howard E. and Moyer, Mary Pat; HIV Replication and persistence in human gastrointestinal cells cultured in vitro.; Journal of Leukocyte Biology, 49:499-504 (1991). Becker, Yechiel; The spreading of HIV-1 infection in the human organism is caused by fractalkine trafficking of the infected lymphocytes – a review, hypothesis and implications for treatment; Virus Genes 34:93-109 (2007). Moyer, ary Pat and Gendelman, Howard E.; HIV Replication and persistence in Human Gastrointestinal cells cultured in vitro.; Journal of Leukocyte Biology 49:499-504 (1991). Al-Mulla, W., Church, D., and Gill, M.J.; Phenotypic variations and switches in HIV isolated from the blood and the gastrointestinal tissues of patients with HIV-1 infection.; Journal of Medical Virology; 52:31-34 (1997). Poles, Michael A., Elliott, Julie and Vingerhoets, Johan, et. al.; Despite high concordance, distinct mutational and phenotypic drug resistance profiles in Human Immunodeficiency Virus Type 1 RNA ane observed in gastrointestinal mucosal biopsy specimens and peripheral blood mononuclear cells compared with plasma.; The Journal of Infectious Diseases; 183:143-8; 2001.

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Q: Why is this life cycle important? A: Understanding the life cycle of HIV is important because it allows us a new window of opportunity for prevention, treatment and the potential cure of HIV infection. I believe that to cure HIV that the HIV life cycle in the gastrointestinal tract needs to be interrupted.

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Q: What do you propose? A: LiSAVIOR, our new drug product is a sulfur based drug that is the first drug to be proposed to be used orally to prevent or eradicate HIV in the gastrointestinal tract. Hershline, Roger K., Antiviral Composition; U.S. Patent No. 6,821,958, November 23, 2004. Hershline, Roger Kenneth; World International Patent Application Number: PCT/US2005/039528, November 5, 2006.

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Q: How does LiSAVIOR work? A: LiSAVIOR would be orally ingested and remain in the gastrointestinal system, essentially coating the entire gut. Extensive studies conducted in cooperation with the National Institute of Health, the world’s experts on HIV infection, have shown that LiSAVIOR is highly effective against HIV. LiSAVIOR prevents both viral entry and cellular transfer of HIV thru both R5 and X4 pathways in CD4 dependant and non-CD4 pathways as demonstrated by these pre-clinical cellular assays. In essence, LiSAVIOR stops HIV. Roger Miller, Ph.D., Report for NIAID Compound: 11039, Specialized In Vitro Virological Evaluations of Strategies to Combat HIV/AIDS, Targeted Interventions Branch National Institutes of Health, September 14, 2007.

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Q: Is there any toxicity? A: No. To date all pre-clinical studies have shown essentially no toxicity. Roger Miller, Ph.D., Special Toxicity Assays Performed for NIAID Compound: 11039, Specialized In Vitro Virological Evaluations of Strategies To Combat HIV/AIDS, Targeted Interventions Branch National Institutes of Health, June 21, 2005.

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Q: This all sounds very exciting. What is next? When will LiSAVIOR be available for general use? A: Yes, it is very exciting. The next phase of the development of LiSAVIOR is to enter formal clinical studies. Global Humanceuticals, Inc. will soon begin this process thru obtaining the names of potential study subjects. As far as availability, we do hope for an FDA fast tract approval to place LiSAVIOR in the hands of physicians within three years. Thank you.

LiSAVIOR : 

LiSAVIOR DR. ROGER KENNETH HERSHLINE PHD MD CEO CUREHIV GLOBALHUMANCEUTICALS, INC. H.Q. MAIL: P.O. BOX 23467 HILTON HEAD ISLAND, SC,29928 E-MAIL: ROGER@CUREHIV.US

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