By: tellslikeitis 21 Sep 2004, 01:45 PM EDT Msg. 168072 of 188686 Jump to msg. #   Barbados Study Abstract: Clinical Results of RETICULOSE in Patients With AIDS NEW YORK, Dec. 10, 1996 -- Advanced Viral Research Corp (Nasdaq Bulletin Board: ADVR) today announced preliminary results of a clinical trial of its peptide nucleic acid drug RETICULOSE in patients with AIDS. The double-blind, randomized, placebo-controlled clinical trial is being conducted at The Queen Elizabeth Hospital, University of the West Indies School of Medicine, Barbados, by Henry Fraser, M.D., Timothy Roach, M.D., and Paul Levett, Ph.D. According to a written summary of the trial by Dr. Levett, forty-three patients never previously treated with HIV anti-retroviral therapy, were enrolled in the study. Twenty-one patients received RETICULOSE and twenty-two patients received placebo, administered daily, every other week, for a sixty-day period. Patients were observed for another sixty days following the conclusion of treatment. The polymerase chain reaction (PCR) assays for viral load were performed by LabCorp (Roche), and the CD4 counts were performed by SmithKline Beecham Clinical Laboratories. At the end of the sixty-day treatment period, the key results of this preliminary report were: -- A 37 percent increase in the mean CD4 positive T-cell lymphocytes counts in patients receiving RETICULOSE as compared with a 7 percent decrease in the control group that received placebo, and -- A 21 percent average decrease in HIV viral load, as measured by quantitative RNA PCR, in the RETICULOSE-treated patients, in contrast to a 33 percent increase in HIV viral load in the control group. At the end of the sixty-day observation period the mean HIV viral load of the treated group was less than half (42 percent) of the control group. Eighty-three percent of the patients who received RETICULOSE had a rise in blood hemoglobin and 61 percent had a rise in hemoglobin equal to or greater than one gram per deciliter (gm/dl). In contrast, 44 percent of patients who received placebo had a rise in blood hemoglobin during the study period, and in only 25 percent was the increase equal to or greater than 1 gm/dl. Clinically, 72 percent of patients who were given RETICULOSE maintained or increased their body weight. This occurred in only 30 percent of the placebo-treated patients. There was zero toxicity and no side effects were observed by physicians or reported by patients as a result of RETICULOSE therapy. "In view of the encouraging preliminary results of this clinical study in AIDS patients and the absence of any toxic side effects, we are eager to move forward to the next stage of this clinical trial with RETICULOSE," said Shalom Z. Hirschman, M.D., President and Chief Executive Officer of Advanced Viral Research Corp. "Drs. Fraser, Roach and Levett plan to submit the results for publication upon completion of the trial." The study is being supported by Advanced Viral Research Corp ADVR is developing RETICULOSE, a non-toxic peptide nucleic acid preparation, that in the past was used to treat a number of viral infections. The company has neither monitored nor observed this clinical trial. NOTE: This news release contains forward-looking statements that involve risks and uncertainties, including risks associated with clinical development, regulatory approvals, including application to the FDA, product commercialization and other risks described from time to time in the SEC reports filed by ADVR. RETICULOSE is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries.

By: tellslikeitis 21 Sep 2004, 01:51 PM EDT Msg. 168075 of 188686 Jump to msg. #   CASE STUDIES OF HPV PATIENTS FROM PAPILLOMAVIRUS PATENT EXAMPLE I Five patients, two females and three males, were treated with Product R by topically applying Product R on the lesions which are identified as viral vegetative type warts caused by human papillomavirus (Condyloma acuminatum). Most of these lesions were condylomas acuminatum of short evolution. Product R as defined by the process of manufacture was applied topically to the lesions in amounts that adequately cover the lesions twice per day (morning and evening) for two weeks (about 28 applications). At the end of the treatment period, the lesions were no longer observed. EXAMPLE II Eight patients who were diagnosed as having genital papillomavirus infections were treated with Product R also by topically administering Product R once a week for four weeks. At the end of the treatment period, no visible lesion could be observed in seven of these patients. The treatment results were further confirmed by the subsequent biopsy analysis, which indicated that the tissues were no longer infected.

By: tellslikeitis 21 Sep 2004, 02:01 PM EDT Msg. 168079 of 188686 Jump to msg. #   Method of Stimulating Red Blood Cell Production Patent Accordingly, an object of the present invention is to provide a method comprising the parenteral administration of Product R for stimulating red blood cell production. Another object of the present invention is to provide a method for treating patients suffering from anemia resulting from chronic renal failure, radiation, chemotherapy or AIDS. Specifically, Product R is administered parenterally to the patients in a range from about 5 microliters to about 40 microliters per kilogram of the patient's body weight per day in a sterile injectable formulation. All quantities are subject to plus or minus 2.5% variation for pH, volume, and analytical For the above stimulation of red blood cell production, which is therefore useful for treating anemia such as anemia resulting from chronic renal failure, radiation therapy, chemotherapy or AIDS, a suitable effective dose of Product R is in the range from about 2.5 microliters to about 40 microliters per kilogram of body weight per day, preferably in the range of about 5 microliters to about 25 microliters per kilogram of body weight per day. Most preferably Product R is administered in an amount of about 15 microliters per kilogram of body weight per day for two weeks and then 7.5 microliters per kilogram of body weight per day thereafter. The desired dose may be administered as two, three or more sub-doses at appropriate intervals, generally equally spread in time, throughout the day. Preferably, the full daily dose is administered in one administration. Product R may be administered by any suitable injection route including, but not limited to intravenously, intraperitoneally, subcutaneously, intramuscularly, and intradermally, etc. The presently preferred route of administration is subcutaneously. It will be appreciated that the preferred route may vary with, for example, the condition and age of the recipient. The above method for stimulating red blood cell production may be used to treat patients suffering from various forms of anemia such as anemia caused by chronic renal failure, radiation therapy, chemotherapy or AIDS.

By: SUE32073 21 Sep 2004, 02:01 PM EDT Msg. 168080 of 188686 Jump to msg. #   Does anyone have the link to the "old" ADVR website? Lots of history there and I would just love reviewing history -- history of ADVR is what brought us to the "state" of confusion, whereby some of us exist!...LOL. If I thought for one minute, ADVR's history is, indeed, repeating itself, I would definitely throw in the towel. I know there are a few RA-RA posters here who would sooner "forget" the past mistakes made by ADVR and just hide their heads the sand. Tough nookies!!

By: mind31 21 Sep 2004, 02:07 PM EDT Msg. 168081 of 188686 (This msg. is a reply to 133531 by mind31.) Jump to msg. #   ADVR Reports AVR118 Inhibits Inflammatory Arthritis in Animal Model and in Rheumatoid Arthritis Patients in Human Clinical Trial Wednesday December 3, 1:37 pm ET YONKERS, N.Y., Dec. 3 /PRNewswire-FirstCall/ -- Advanced Viral Research Corp. (OTC Bulletin Board: ADVR - News) today announced that its novel immunomodulator AVR118 (formerly known as Product R) has exhibited therapeutic effects in both an animal model of inflammatory arthritis and in a clinical trial of patients with rheumatoid arthritis. In experiments with an animal model of inflammatory arthritis, performed at The Weizmann Institute of Research in Rehovot, Israel, the administration of AVR118 significantly suppressed the development of inflammation in the animals' joints compared to non-treated control animals. The results in the animal model were validated by an open-label clinical trial conducted in Argentina in 27 patients. All patients in the trial had improvement in quality of life including resolution or significant decrease in intensity of pain, the ability to exercise, to perform housework, and to engage in social activities. In addition, all patients showed objective signs of decreased inflammation, and increased mobility, of affected joints. "These positive results highlight the anti-inflammatory properties of AVR118 and underline the potential of AVR118 as an anti-inflammatory therapeutic agent," said Eli Wilner, Chairman of the Board of ADVR. Animal Model In the Weizmann Institute animal model, inflammatory arthritis was induced by injecting complete Freund's adjuvant containing inactivated Mycobacterium tuberculosis into rats. AVR118 was administered for 14 days out of the twenty-four days that the animals were observed for the full development of inflammation. The anti-inflammatory effects of AVR118 were evident even for the ten days following the discontinuation of the drug. This adjuvant arthritis model in animals serves as an experimental model for human rheumatoid arthritis. Clinical Study In the clinical trial, 27 female patients, ranging in age from 29 to 50 years, with mild to moderately severe rheumatoid arthritis, were treated with AVR118 for a period of 90 days. These patients had previously been treated with other anti-inflammatory drugs such as aspirin. By day 90, all patients had either complete regression or significant decrease of joint swelling. Measurements of joint mobility showed improvement in all patients. All patients showed decreases in the level of the erythrocyte sedimentation rate (ESR) by day 90 of therapy and most patients showed decreases in the latex fixation test. There were no significant side effects of AVR118 observed in this study. "Inflammation and cachexia are inextricably linked by metabolic pathways that have common origins and targets; areas where modulation can occur for maximum impact on the process," said James T. D'Olimpio M.D., a clinical consultant to ADVR and expert in the treatment of cachexia. "In addition, the pathways involved with inflammation are not just confined to separate and distinct disease entities, but are a common thread that impacts on quality of life in many unrelated diseases such as AIDS, Cancer, Rheumatoid Arthritis and other conditions in which weight loss, weakness, poor outcomes and non- compliance to treatment are major clinical concerns. These results appear to confirm the potent anti-inflammatory properties of AVR118." Cytokines and chemokines play important roles in the progression of rheumatoid arthritis. The development of clinical rheumatoid joint inflammation is associated with increase of the chemokine interleukin-8 (IL-8) in joint tissue. Pro-inflammatory cytokines such as interleukin-1 (IL-1), tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6) are present at high levels in arthritic joints and their blood concentrations increase with the severity of the disease. Monocytes migrate into the joints from the blood and are activated to differentiate into macrophages in the joint tissue by inflammatory cytokines and chemokines such as IL-1, IL-6, IL-8, and TNF-alpha. Activated macrophages play an important role in joint inflammation and destruction. The joint tissue attracts the monocytes into the joints through the production of the chemokines monocyte chemoattractant protein-1 (MCP-1) and IL-8. In laboratory experiments ADVR scientists have shown that AVR118 modulates the synthesis of cytokines and chemokines including MCP-1, IL-8, IL-1 beta, and IL-6. Although AVR118 stimulates the synthesis of the pro-inflammatory chemokines MCP-1 and IL-8 by native monocytes in cell culture, highly activated macrophages are turned off with decreased synthesis of MCP-1 and IL-8. "Rheumatoid arthritis is a systemic disease that serves as a model for other auto-immune diseases. The anti-inflammatory activity of AVR118 in the animal model, and in the rheumatoid arthritis patients in the clinical trial, including the amelioration of the systemic manifestations of the disease, suggests the possibility of treating not only Rheumatoid Arthritis with AVR118 but also a broad range of inflammatory processes associated with human diseases," explained Shalom Z. Hirschman, M.D., Chief Scientist at ADVR. "In the laboratory, AVR118 modulates the synthesis of pro-inflammatory cytokines and chemokines implicated in the inflammatory process in patients with Rheumatoid Arthritis. If these clinical results are validated by future clinical trials, then AVR118 would represent an important advance in the treatment of this systemic disease marked by crippling arthritis." "The potential of a non-toxic immunomodulator such as AVR118 in the therapy of Rheumatoid Arthritis could be significant, as AVR118 appears to lack the often toxic effects of currently used mainstay therapies such as corticosteroids, COX inhibitors, gold compounds and methotrexate," stated Irach Taraporewala, Ph.D., ADVR's head of structural chemistry. Dr. Taraporewala is an experienced research scientist in the design of anti-inflammatory small molecules for the treatment of rheumatoid arthritis. Rheumatoid Arthritis Market Rheumatoid arthritis usually begins between the ages of 25 to 55 years. More than 85% of patients with rheumatoid arthritis are over the age of 50. Among patients with rheumatoid arthritis, women outnumber men by three to one. In the United States, approximately 1% of the population, or 2.5 million people, have rheumatoid arthritis. It occurs in of all ethnic groups and in all parts of the world. As the population in the developing world ages, and with a rising incidence of the disease, the world market for safe and effective rheumatoid arthritis treatment is projected to reach $6.6 billion annually by the year 2009. ADVR's AVR118 represents a biopolymer chemistry that possesses novel immunomodulator activity. This peptide-nucleic acid, which to date has shown no indication of human toxicity, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papilloma virus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. Therefore, AVR118 has been termed a "switch-type" immunomodulator. AVR118 is in clinical trials in Israel for the treatment of cachexia (body wasting) in patients with AIDS. For further information regarding Advanced Viral Research Corp., please visit our website at www.adviral.com. Advanced Viral Research Corp., based in Yonkers, New York, is a biopharmaceutical firm dedicated to improving patients' lives by researching, developing and bringing to market new and effective therapies for viral and other diseases. Note: This news release contains forward-looking statements that involve risks associated with clinical development, regulatory approvals, including application to the FDA, product commercialization and other risks described from time to time in the SEC reports filed by the Company. AVR118 (Product R) is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries. There is no assurance that the Company will be able to secure the financing necessary to continue and/or complete the clinical trials of AVR118 or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company. The Company undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise. Contact: Eli Wilner 914-376-7383

By: tellslikeitis 21 Sep 2004, 02:07 PM EDT Msg. 168082 of 188686 Jump to msg. #   Announcement of Phase III IND in Argentina Advanced Viral Research Corp. Announces Phase 3 IND Number from Argentina for HIV/HPV Studies Using Reticulose PR Newswire; Tuesday March 31, 12:27 pm EST YONKERS, N.Y., March 31 /PRNewswire/ -- Advanced Viral Research Corp. (OTC Bulletin Board: ADVR - news) today announced that its flagship drug RETICULOSE, has received an Investigational New Drug (IND) number from the ANMAT, the FDA of Argentina, for final (phase 3) testing in patients infected with HIV and the Human Papilloma Virus (HPV). The studies under this IND number are the final step in the approval process in Argentina. HPV infection is a sexually transmitted disease of world-wide incidence that is the cause of genital warts and has been implicated as a cause of cervical cancer in women. Reticulose is a non-toxic immunomodulator that has been shown to have broad spectrum antiviral activity. Argentina is an important member of the Mercosur States, that include Bolivia, Brazil, Uruguay, Paraguay, and Chile. These countries have a combined population of approximately 250 million people, thus providing a potentially large market of RETICULOSE. "The granting of an IND number for the use of Reticulose in Argentina is an important event for the company," said Dr. Shalom Z. Hirschman, President and CEO of Advanced Viral Research Corp. "We expect that this will result in the approval to market Reticulose in Argentina for the treatment of HIV and HPV infected patients and to be followed with approvals by the other Mercosur States." NOTE: This news release contains forward-looking statements that involve risks and uncertainties, including risks associated with clinical development, regulatory approvals, including application to FDA, product commercialization and other risks described from time to time in the SEC reports filed by ADVR. RETICULOSE is not approved by the U.S. Food and Drug Administration or any comparable agency of any other countries. SOURCE: Advanced Viral Research Corp. March 31, 1998

 

By: mind31 21 Sep 2004, 02:09 PM EDT Msg. 168084 of 188686 (This msg. is a reply to 168081 by mind31.) Jump to msg. #   They fail to mention that some patients were taking paracetimol (tylenol) and one was taking predinisome, a powerful seroid but it is in the patent application if I ever find it. - - - - - View Replies »

 

By: tellslikeitis 21 Sep 2004, 02:14 PM EDT Msg. 168086 of 188686 Jump to msg. #   Phase I studies approved in Argentina (two years after thePhaseIII studies in my previous post?) ADVANCED VIRAL RESEARCH CORP. RECEIVES APPROVAL IN ARGENTINA FOR HUMAN CLINICAL STUDIES WITH ANTIVIRAL "Product R" Research Shows Drug Inhibits Production of CCR5, Stimulates the Immune System & Interferes with Viral Replication to Fight AIDS, HPV & Other Diseases YONKERS, NY - February 18, 2000 - Advanced Viral Research Corp. (OTC BB:ADVR) today announced that Product R, its non-toxic peptide nucleic acid (PNA) immunomodulator, has received formal approval for Phase I human clinical studies in Argentina. Product R is a non-toxic peptide nucleic acid being developed by the company as a broad spectrum antiviral drug. The drug shows promise for the treatment of viral infections such as AIDS and Human Papilloma Virus (HPV), and autoimmune diseases like rheumatoid arthritis and diabetes mellitus. Peptide nucleic acids are stable analogues of genes and have applications as genomics. Advanced Viral Research Corp. laboratory studies have shown that Product R inhibits the production of both the CCR5 and CXCR4 chemokine receptors, the key cellular co-receptors for the human immunodeficiency virus (HIV). "The approval of human trials in Argentina is a very important step on the road to making Product R available for clinical use worldwide," said Shalom Z. Hirschman, M.D., President and Chief Executive Officer of Advanced Viral Research Corp. "Working with our scientific colleagues in Argentina, we have successfully laid the groundwork to move our application through ANMAT (the Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica -- National Administration for Drug, Food and Medical Technology), so that we may market Product R in their country, helping to alleviate the suffering of people with a variety of debilitating diseases. I am especially gratified that the clinical approvals are progressing as planned in Argentina while we prepare our applications to the FDA in the United States," Dr. Hirschman stated. Clinical trials in patients with AIDS and HPV (the cause of genital warts and a critical factor in the development of cervical cancer) are planned in Argentina. The approval for human clinical tests in Argentina also paves the way for future study of the therapeutic effects of Product R in other important diseases, such as rheumatoid arthritis and diabetes mellitus. Product R is a second-generation therapeutic. Its predecessor was developed in the early 1900s. Using modern medical technology, scientists at The Advanced Viral Research Institute have refined the PNA preparation and pharmaceutical production, making today's Product R a truly novel drug. About The Advanced Viral Research Institute Advanced Viral Research Corp.'s foundation begins with a dedication to scientific research and cutting-edge innovation. In that spirit, the company created The Advanced Viral Research Institute to foster individual scientific inquiry and creativity. Here, a respected team of molecular biologists, immunologists and other scientists conduct biomedical research in an academically oriented environment. The Advanced Viral Research Institute also is developing other PNA-based therapeutics. About Advanced Viral Research Corp. Advanced Viral Research Corp., based in Yonkers, New York, is a biopharmaceutical firm committed to researching, developing and bringing to market new, effective therapies for viral and other diseases. Its flagship drug, Product R, is a non-toxic immunomodulator that has been shown to have beneficial therapeutic effects against viral diseases such as AIDS.

By: tellslikeitis 21 Sep 2004, 02:22 PM EDT Msg. 168089 of 188686 Jump to msg. #   1996 Argentina Clinical Trial in HPV Announcement Advanced Viral Research announces clinical trial BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - HALLANDALE, FLA. (April 30) BUSINESS WIRE -April 30, 1996--Advanced Viral Research Corp. (OTC:ADVR) announced today that an open label trial on 20 human patients to assess the efficacy of the company's drug Reticulose on the Human Papilloma Virus (HPV) began on April 15, 1996. HPV is a sexually transmitted disease which is manifested as genital warts. The trial is being conducted by Juan Carlos Flichman, M.D. at two hospitals in Buenos Aires, Argentina pursuant to a protocol developed by Dr. Flichman. The protocol will be using the most modern technology of molecular biology to assess the effects of Reticulose on HPV infection. A report of this trial is expected at the end of the 90-day trial period. Funding for the trial as well as supplies of the drug are being supplied by Advanced Viral. Dr. Flichman is a charter member of the Ministry of Health in control of sexually transmitted diseases and AIDS, is presently President of the Union of Argentina Against Sexually Transmitted Diseases (UACETS), and also President of the Union of Latin America Against Sexually Tranmitted Diseases (ULACETS). Reticulose is a non-toxic anti-viral peptide nucleic acid preparation by Advanced Viral Research Corp. which, based on previous history, has been shown to be effective against a number of viral diseases. --30--csm/ny CONTACT: Advanced Viral Research Corp. William Bregman 954/458-7636 or KCSA Public Relations Adam I. Friedman/Howard E. Wishner 212/682-6300 ext. 215/210

 

By: SUE32073 21 Sep 2004, 02:41 PM EDT Msg. 168091 of 188686 Jump to msg. #   http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=%22advanced+viral+research%22&FIELD1=&co1=AND&TERM2=hirschman&FIELD2=&d=PG01

 

By: SUE32073 21 Sep 2004, 02:45 PM EDT Msg. 168092 of 188686 Jump to msg. #   http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=%22advanced+viral+research%22&FIELD1=&co1=AND&TERM2=hirschman&FIELD2=&d=ptxt - - - - - View Replies »

By: tellslikeitis 21 Sep 2004, 03:12 PM EDT Msg. 168098 of 188686 Jump to msg. #   Multiple Sclerosis Animal Study PR Advanced Viral Research Corp. today announced that administration of its novel immunomodulator AVR118 (formerly known as Product R) in animals with induced experimental allergic encephalomyelitis (EAE) suppressed progression of this demyelinating neurological disease. This animal model, developed by the Weizmann Institute of Science in Rehovot, Israel, serves as a potential model for the use of AVR118 in the treatment of the human auto-immune demyelinating disease, multiple sclerosis (MS). Full Story Below AVR118 Suppresses Progression of Disease in Animal Model of Multiple Sclerosis Developed at The Weizmann Institute of Science YONKERS, N.Y.--(BUSINESS WIRE)--Dec. 9, 2003--Advanced Viral Research Corp. (OTCBB: ADVR) today announced that administration of its novel immunomodulator AVR118 (formerly known as Product R) in animals with induced experimental allergic encephalomyelitis (EAE) suppressed progression of this demyelinating neurological disease. This animal model, developed by the Weizmann Institute of Science in Rehovot, Israel, serves as a potential model for the use of AVR118 in the treatment of the human auto-immune demyelinating disease, multiple sclerosis (MS). EAE is a demyelinating disease of the central nervous system that serves as an animal model for multiple sclerosis. In experiments conducted at the Weizmann Institute, AVR118 was delivered to the animals through subcutaneously implanted infusion pumps for fourteen days concomitantly with the induction of the disease in rats by injection of basic myelin protein. AVR118 markedly inhibited the progression of experimental allergic encephalomyelitis in all the rats treated. Effects on the disease ceased when treatment with AVR118 was discontinued. Furthermore, when AVR118 was fed orally to experimental rats there was a dose-dependent suppression of the demyelination that marks EAE. "The positive results observed with AVR118 in the animal model emphasizes the broad potential for treatment of auto-immune diseases based on the anti-inflammatory properties of this novel drug," said Maribel de Diego, Ph.D., ADVR's head of immunology. "It is likely that the therapeutic activity of AVR118 in EAE is due to the drug's modulating effects on cytokines and chemokines. The strong effects of AVR118 in suppressing the progression of the demyelinating disease in the model in rats serve as an impetus for future clinical study of the possible therapeutic role for AVR118 in multiple sclerosis." Multiple Sclerosis The prevalence rate of multiple sclerosis is 1 in 700 (0.14%) according to the National Institute of Allergy and Infectious Disease (NIAID); thus there are approximately 388,000 patients with the disease in the United States. The sex ratio of incident cases is about 2.3 to 1, women to men. The age of onset peaks between 20 and 30 years. Approximately 70% of patients manifest symptoms between the ages of 21 and 40. The risk of multiple sclerosis is higher both in temperate climates and among people of northern European decent. "These animal studies provide clinicians with critical information necessary for future approval for human trials," said James T. D'Olimpio M.D., a clinical consultant to ADVR. "These results are highly relevant in validating the scientific principles that will lead the medical community into understanding a potentially new therapeutic class of drugs. These tests are an important first step in translating meaningful basic science to the bedside, where the resulting medications may help a wide variety of patients suffering the consequences of chronic disease and the inflammatory mechanisms that modulate this suffering." ADVR's AVR118 (formerly known as Product R) represents a biopolymer chemistry that possesses novel immunomodulator activity. This peptide-nucleic acid, which to date has shown no indication of human toxicity, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papilloma virus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. Therefore, AVR118 has been termed a "switch-type" immunomodulator. AVR118 is in clinical trials in Israel for the treatment of cachexia (body wasting) in patients with AIDS.

 

By: Ourobouros 21 Sep 2004, 04:02 PM EDT Msg. 168122 of 188686 (This msg. is a reply to 168064 by shaggydogs.) Jump to msg. #   I stand corrected...yes it was the Barbados study. However my depiction about the way Hirschman turned his back on all outside contacts stands. - - - - - View Replies »

By: lovingitall0 22 Sep 2004, 12:07 PM EDT Msg. 168362 of 188686 Jump to msg. #   ***Re ADVR and AVR118: Well done! Listen to it again! The presentation by our CEO and President, Dr. Elma Hawkins, at The Wall Street Analyst Forum Conference on September 13, will be available for 30 days thereafter. Dr. Hawkins discussed the progress the company is making with its flagship product, AVR118, to biotech and pharmaceutical analysts. You can hear it at the following web address: http://www.vcallconferences.com/conferences/WallStreetAnalystForum/091304/index.asp?Day=1

By: SUE32073 22 Sep 2004, 02:11 PM EDT Msg. 168417 of 188686 (This msg. is a reply to 168416 by buckaroobanzai10.) Jump to msg. #   Wouldn't your theory then make the number 13. Remember, we talking U.S. Patents issued. "We have 12 issued U.S. patents, some covering the composition of AVR118 and others covering various uses of AVR118. We have eight pending U.S. patent applications and 18 pending foreign patent applications. In addition, we have two issued Australian patents and one issued Chinese patent covering several uses of AVR118." - - - - - View Replies »

By: buckaroobanzai10 22 Sep 2004, 04:18 PM EDT Msg. 168477 of 188686 Jump to msg. #   Cytokine Journal Article Abstract : 1: Cytokine. 2001 May 21;14(4):234-9. IL-8 and MCP-1 secretion is enhanced by the peptide-nucleic acid immunomodulator, Product R, in U937 cells and primary human monocytes. Lazzarino DA, de Diego M, Hirschman SZ, Zhang KY, Shaikh S, Musi E, Liaw L, Alexander RJ. Laboratory of Immunology, Advanced Viral Research Institute, Advanced Viral Research Corp., 200 Corporate Boulevard South, Yonkers, New York 10701, USA. Product R (Reticulose) is a peptide-nucleic acid immunomodulator recently shown to enhance the expression of mRNAs encoding pro-inflammatory cytokines. Interleukin 8 (IL-8) and macrophage chemoattractant protein-1 (MCP-1) are pro-inflammatory chemokines involved in immune cell mobilization and stimulation. To determine whether Product R acts by upregulating these chemokines, we assayed its effects on the expression of IL-8 and MCP-1 mRNAs and proteins by human monocytic U937 cells and by adherent peripheral blood mononuclear cells (PBMCs). U937 cells were cultured for 0-21 days in media containing 0-20% Product R or phosphate-buffered saline (PBS). Compared to control cultures, cells cultured in Product R expressed increased amounts of IL-8 and MCP-1 mRNAs, as measured by reverse transcriptase-polymerase chain reaction (RT-PCR). Product R also increased secretion of IL-8 and MCP-1, as measured by enzyme-linked immunosorbent assay (ELISA), and boosted secretion induced by bacterial lipopolysaccharide (LPS), in a time- and dose-dependent manner. In adherent PBMCs, Product R increased IL-8 and MCP-1 secretion, but reduced LPS-induced MCP-1 secretion. While mRNAs encoding the IL-8 receptor, CXCR2, and the MCP-1 receptor, CCR2, were increased in U937 cells cultured in 5-10% Product R, we observed no change in binding of receptor-specific antibodies. These findings suggest that Product R upregulates the expression of IL-8 and MCP-1, which may boost immune system activity in virally-infected patients. Copyright 2001 Academic Press. - - - - - View Replies »

By: buckaroobanzai10 22 Sep 2004, 04:33 PM EDT Msg. 168484 of 188686 (This msg. is a reply to 168475 by lovingitall0.) Jump to msg. #   While AVR118 has been described as an 'antisense' PNA drug in some publications, no publication from the company deals with antisense effects of the drug. "Antisense" refers to the actions of classic synthetic PNAs, which are mimics of short segments of DNA or RNA nucleic acids with a peptide backbone. They bind strongly to the gene-coding segments of DNA (the "sense strand of DNA) in cells and thus prevent the effects of the gene's activation. They block the actions of the DNA sense-strand, and therefore are called 'anti-sense'. The patent on AVR118 chemical structure identifying the ingredients reveals that the drug has two main peptides. One is a normal peptide. The other is a peptide attached to a very short RNA fragment. So, it can very loosely be called a peptide-nucleic acid (PNA), but in no way is it sructurally to functionally to the synthetic PNAs that other companies and researchers are working on. - - - - - View Replies »

 

By: lovingitall0 22 Sep 2004, 05:24 PM EDT Msg. 168493 of 188686 (This msg. is a reply to 168488 by mind31.) Jump to msg. #   Yes, "hon", the point is Dr. Hirschman talks about PNA's and antisense activity in 1996 when it was was in its infancy. Now, everyone is on the bandwagon. This goes for many of his abstracts. He was always several steps ahead of everyone in the science. We just have to implement it into successful, proven clinical trials already, and get AVR118 to market while we're all still alive to see it and enjoy it. Luv - - - - - View Replies »

By: lovingitall0 22 Sep 2004, 05:44 PM EDT Msg. 168498 of 188686 (This msg. is a reply to 168495 by mind31.) Jump to msg. #   Anti-Cachectic Effects of a Novel Peptide Nucleic Acid Complex: By: fenderbender60 06 Jun 2004, 04:03 PM EDT Msg. 156057 of 168496 ADVR Presented Results of its AVR118 Phase 1/2 Clinical Program at ASCO via COMTEX June 6, 2004 YONKERS, N.Y., Jun 6, 2004 /PRNewswire-FirstCall via COMTEX/ -- Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) announced today that the company presented interim results of its Phase 1/2 clinical program with its flagship product, AVR118, at The American Society of Clinical Oncology's (ASCO) 40th Annual Meeting in New Orleans, LA. The presentation 'Anti-Cachectic Effects of a Novel Peptide Nucleic Acid Complex: Preliminary Results of a Phase1/2 Clinical Trial,'given by James T. D'Olimpio M.D, showed the results of Phase 1/2 clinical trials conducted in Israel. A total of 25 cachectic patients (patients with cancer cachexia or AIDS wasting) were enrolled in the trials. Ten patients with advanced AIDS and two patients with advanced pancreatic cancer received AVR118 subcutaneously at a dose of 0.4 ml/day for 28 days (6 days/week). Eight AIDS patients received a dose of 2.0 ml/day and five patients received 4.0 ml/day at the same schedule. All patients were followed for 28 days after treatment was completed. Total weight, body mass index (BMI), fat percentage, strength, calf and arm circumference, and skin fold were measured for all AIDS patients. Spontaneous patient comments regarding quality of life (QOL) parameters, including improvement in mood, appetite, alertness, activities of daily living (ADLs), malaise, myalgia and power/energy were recorded. Adverse events were monitored. All dose groups showed an increase in weight, strength and fat percentage, with more significant improvements in the two higher dose levels. All patients with anorexia at entry became anorexia-free after three weeks of therapy. Spontaneous patient comments reflect widespread, dose-related improvements in Quality of Life (QOL). AVR118 continues to show a favorable safety profile. 'This trial was designed as a dose-escalation study and we are pleasantly surprised to see such strong data given the relatively short treatment period,'said Dr. Elma Hawkins, President and CEO of Advanced Viral Research Corp. 'We are very encouraged by the results, most importantly with the resolution of anorexia in all study participants.' Results Reported - AIDS: 0.4 ml dose * All patients were anorexia-free after three weeks of treatment. (One patient did not have anorexia at baseline). * Half of the patients reported increased daily activity. 2 ml dose * All patients were anorexia-free after three weeks of treatment. * At the end of four weeks of treatment the average weight of patients increased by over a pound. * All patients had an increase of fat percentage after treatment and this was sustained in the majority of patients. * Approximately half of the patients reported an improvement in their mood and increased daily activities. 4 ml dose * All patients were anorexia free after three weeks of treatment. It is important to note that 50 percent of patients had Grade Two anorexia at baseline. * Patients in this cohort increased their average weight by 2.2 pounds over four weeks of treatment. This effect continued through the following four weeks at which point the average weight had increased by 2.6 pounds over baseline. * All patients showed an increase in fat percentage which was sustained after treatment discontinuation in all patients. * 100 percent of patients reported an increase in daily activity. * 80 percent of patients reported decreased fatigue. Results Reported - Pancreatic Cancer: * Both patients had improved weight (4% increase) * Improved fat percentage (20% increase) * Improved strength (5 % increase) ADVR's AVR118 represents a biopolymer that possesses novel immunomodulator activity. This peptide-nucleic acid complex, which to date has demonstrated a very favorable safety profile, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. AVR118 is in clinical trials in Israel for the treatment of cachexia (body wasting) in patients with AIDS. For further information regarding Advanced Viral Research Corp., please visit our website at http://www.adviral.com. Advanced Viral Research Corp., based in Yonkers, New York, is a biopharmaceutical firm dedicated to improving patients'lives by researching, developing and bringing to market new and effective therapies for viral and other diseases. Note: This news release contains forward-looking statements that involve risks associated with clinical development, regulatory approvals, including application to the FDA, product commercialization and other risks described from time to time in the SEC reports filed by the Company. AVR118 (Product R) is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries. There is no assurance that the Company will be able to secure the financing necessary to continue and/or complete the clinical trials of AVR118 or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company or that if completed, clinical trials performed outside the United States will assist the Company in obtaining FDA or other regulatory approval. The Company undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise. Contact: Ronnie Welch or Kelly Cinelli CWR &Partners 508/222-4802 SOURCE Advanced Viral Research Corp. Ronnie Welch or Kelly Cinelli, both of CWR &Partners, +1-508-222-4802 /Company News On-Call: http://www.prnewswire.com/comp/903002.html http://www.adviral.com - - - - -

 

By: lovingitall0 23 Sep 2004, 10:14 AM EDT Msg. 168610 of 188686 Jump to msg. #   Good Morning: AVR118 and Peptide Nucleic Acid Complexes A couple of years ago, I remember reading on one of the ADVR Message Boards a post by someone that impressed me very much. As the author discussed the important potential of Product R/AVR118 as an AIDS treatment, he mentioned there was also the excitement being generated as what he referred to as "The New Biology". The writer went into how Peptide Nucleic Acid Complexes are part of our growing understanding of the importance of anti-sense regulation of specific gene signals and that the one "who can block the receptor first" issue really isn't that important in the overall scheme of things, but that the ability to "turn off or on" a genetic signal using this technology is incredibly seminal to reversing and curing disease...since most disease is either infectious as a promoter or inflammatory as a modulator, the New Biology...our understanding of genetic mapping and signals will lead to the New Therapeutics, agents which will interrupt the message that cause cellular damage. The writer also believed that Product R [now AVR118] will do this, and that we would be applying these Peptide Nucleic Acids to cancer, autoimmune diseases, MS, RA, and a host of others. This is exactly what I see we are accomplishing today. Dr. Hirschman's knowledge of science was years ahead of many others in his field. He had a vision of the potential of Reticulose/ AVR118 and now it's all coming together. So, no, I can't agree with anyone who says that we're not a PNA and have nothing to do with anti-sense. Read Dr. James T. D'Olimpio's AVR118 abstract presentation entitled "Use of a Peptide Nucleic Acid Complex in Cancer Regulation and Metastasis at 1st ISC International Conference on Cancer Therapeutics Molecular Targets in Florence, Italy. Read The presentation on 'Anti-Cachectic Effects of a Novel Peptide Nucleic Acid Complex: AVR118, Preliminary Results of a Phase1/2 Clinical Trial, ' given by Dr. James T. D'Olimpio at The American Society of Clinical Oncology's (ASCO) 40th Annual Meeting in New Orleans, LA. Listen to the great interviews again on the ADVR website. Mindless Barry can call me anything he wants to, and he does, but he's not the sharpest pencil in the box and that's obvious by his actions. He just can't stand anyone's opinion on anything but his own. Well, this is mine. Luv http://ragingbull.lycos.com/mboard/boards.cgi?board=ADVR&read=168498 http://www.adviral.com/ADVR/news/index.htm http://ragingbull.lycos.com/mboard/boards.cgi?board=ADVR&read=168362 - - - - - View Replies »

By: lovingitall0 23 Sep 2004, 01:47 PM EDT Msg. 168616 of 188686 Jump to msg. #   (Any good cookie recipes???) Cannabis May Help Combat Cancer-Causing Herpes Viruses 9/22/2004 Source: University of South Florida Health Sciences Center The compound in marijuana that produces a high, delta-9 tetrahydrocannbinol or THC, may block the spread of several forms of cancer causing herpes viruses, University of South Florida College of Medicine scientists report. The findings, published Sept. 15 in the online journal BMC Medicine, could lead to the creation of antiviral drugs based on nonpsychoactive derivatives of THC. The gamma herpes viruses include Kaposi's Sarcoma Associated Herpes virus, which is associated with an increased risk of cancer that is particularly prevalent in AIDS sufferers. Another is Epstein-Barr virus, which predisposes infected individuals to cancers such as Burkitt's lymphoma and Hodgkin's disease. Once a person is infected, these viruses can remain dormant for long periods within white blood cells before they burst out and begin replicating. This reactivation of the virus boosts the number of cells infected thereby increasing the chances that the cells will become cancerous. The USF team, led by virologist Peter Medveczky, MD, found that this sudden reactivation was prevented if infected cells were grown in the presence of THC. While cells infected with a mouse gamma herpes virus normally died when the virus was reactivated, these same cells survived when cultured in the laboratory along with the cannabinoid compound – further evidence that THC prevents viral reactivation. Furthermore, the researchers showed that THC acts specifically on gamma herpes viruses. The chemical had no effect on another related virus, herpes simplex-1, which causes cold sores and genital herpes. Small concentrations of THC were more potent and selective against gamma herpes viruses than the commonly used antiviral drugs acyclovir, gancicyclovir and foscamet, said Dr. Medveczky, a professor in the Department of Medical Microbiology and Immunology. The USF researchers suggest that THC selectively inhibits the spread of gamma herpes viruses by targeting a gene these viruses all share called ORF50. - - - - - View Replies »

By: lovingitall0 25 Sep 2004, 12:33 PM EDT Msg. 168784 of 188686 Jump to msg. #   Fast Track Drug Development Programs — Designation, Development, and Application Review The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, “Expediting study and approval of fast track drugs.” "This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a “rolling submission” for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development." http://www.fda.gov/cber/gdlns/fsttrk.htm#iii - - - - -

 

By: lovingitall0 26 Sep 2004, 10:27 AM EDT Msg. 168812 of 188686 Jump to msg. #   Autoimmune Diseases Share Inflammatory Mechanism 08 September 2004 Researchers have found that antibodies from patients with rheumatoid arthritis are able to induce cytokine production through the insulin-like growth factor-1 receptor (IGF-1R) pathway in a fashion identical to that previously shown for antibodies from patients with Grave’s disease. Investigators from the University of California, Los Angeles (USA), reported in the September 1, 2004, issue of the Journal of Immunology that antibodies from individuals with active rheumatoid arthritis (RA-IgG) stimulate their synovial fibroblasts to express the CD4-specific T lymphocyte chemoattractant, IL-16, and RANTES, a C-C chemokine. This induction, which is identical to that previously reported for patients with Grave’s disease, is mediated through the insulin-like growth factor-1 receptor (IGF-1R) pathway. Antibodies from individuals without known autoimmune disease fail to elicit this chemoattractant production. If these findings can be extended to other autoimmune disorders such as multiple sclerosis and lupus, it may be possible to develop a common therapeutic strategy for these conditions. Senior author Dr. Terry J. Smith, a professor in the division of molecular medicine at UCLA said, “It is possible that these findings will allow us for the first time to interrupt the disease process before any lasting damage occurs.”   Advertisements

 

By: SPARKR 26 Sep 2004, 10:58 AM EDT Msg. 168815 of 188686 (This msg. is a reply to 168784 by lovingitall0.) Jump to msg. #   lovingitall0's: "Fast Track" Status Seems Feasible For ADVR's IND Application !!! According to the below excerpt taken from the FDA link you provided, it would be permissible for ADVR to request a Fast Track Designation for AVR118 at the time of it's IND submission , contrary to past statements made on this forum that it could not !!! If fast track status is accepted by the FDA , wouldn't that be a huge lift for our pps !!! I believe Elma IS heading in the direction of Fast Track for AVR118 !!! Only a few more months and we will find out !!! Remember, FAST TRACK was one of Elma's focused "characteristics criteria" in choosing an indication for an IND : - Address an important medical need - Prior experiences in the indication - Sufficient patient population - Small sample size - Clinical trials of short duration - Clear, objective, validated endpoints - *** ELIGIBLE FOR SPECIAL REGULATORY CONSIDERATIONS *** - Ideally minimal competition from which cometh the crucial , planned , methodical, strategic and focused decision announced in ADVR's last PR: "From the successful Pre-IND Meeting with FDA , Advanced Viral Research Corp. believes it is well positioned to submit an IND application for the INJECTABLE USE OF AVR118 IN PATIENTS WITH CANCER by the end of 2004 or beginning of 2005." ______________________________________________________ From your link : "PROCESS FOR DESIGNATING A DRUG FOR THE FAST TRACK DRUG DEVELOPMENT PROGRAM The general procedures applicable to the submission and review of fast track designation requests are described below. Timing of Submission A sponsor may submit a request for fast track designation at the time of original submission of its IND, or at any time thereafter prior to receiving marketing approval of its BLA or NDA. Note that the IND and potential fast track designation may be discussed prior to an IND submission in a pre-IND meeting, but a decision on designation would await submission of the IND. Although benefits associated with fast track designation may occur throughout the drug development process, from the early IND submission to evaluation of a marketing application, as a practical matter, requests should ordinarily occur no later than the sponsor's pre-BLA/NDA meeting with the Agency, as many of the benefits of fast track designation will no longer be applicable after that time. " ITS ALL COMMING TOGETHER QUITE METHODICALLY THANKS TO DR. ELMA S. HAWKINS!!! LOL SPARKR (Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy) - - - - - View Replies »