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Yank on this..... Hirschman Agreement In May 1995, the Company entered into a consulting agreement with Shalom Hirschman, M.D., Professor of Medicine of Mt. Sinai School of Medicine, New York, New York and Director of Mt. Sinai's Division of Infectious Diseases, whereby Dr. Hirschman shall provide consulting services to the Company through May 1997. The consulting services included the development and location of pharmaceutical and biotechnology joint venture partners and assisting the Company with regulatory approvals and protocols. In connection with the consulting agreement, the Company issued to Dr. Hirschman 1,000,000 shares of the Company's Common Stock and the option to acquire 5,000,000 shares of the Company's Common Stock for a period of three years as per the vesting schedule as referred to in the agreement, at a purchase price of $0.18 per share. In addition and in connection with entering into the consulting agreement with Dr. Hirschman, the Company issued to a person unaffiliated with the Company, 100,000 shares of the Company's Common Stock, and an option to acquire for a period of one year, from June 1, 1995 an additional 500,000 shares at a purchase price of $0.18 per share. As of March 31, 1996, no options had been exercised under this Agreement. In March 1996 the Company entered into an Addendum to Agreement with Dr. Hirschman whereby Dr. Hirschman agreed to provide consulting services to the Company through May 2000 (the "Addendum"). Pursuant to the Addendum, the Company granted to Dr. Hirschman the option to purchase 15,000,000 shares of the Company's Common Stock for a three year period pursuant to the following vesting schedule: (i) options to purchase 5,000,000 shares exercisable at any time and from time to time commencing March 24, 1996 and ending March 23, 1999 at an exercise price of $.19 per share; (ii) options to purchase 5,000,000 shares exercisable at any time and from time to time commencing March 24, 1997 and ending March 23, 1999 at an exercise price of $.27 per share; and (iii) options to purchase 5,000,000 shares exercisable at any time and from time to time commencing March 23, 1998 and ending March 23, 1999 at an exercise price of $.36 per share. In addition, the Company has agreed to cause the shares underlying these options to be registered so long as there is no cost to the Company. http://www.sec.gov/Archives/edgar/data/786623/0000950144-96-002732.txt |
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AVR118 IN THIS SECTION... AVR118 Clinical Development Program Potential Market CLINICAL DEVELOPMENT PROGRAM U.S. Topical Clinical Studies The Company successfully submitted an IND for the topical treatment of genital warts in 2001 and a Phase I safety study was successfully completed in healthy volunteers with the current liquid formulation. In April 2002, the Company announced that it had submitted to the FDA the results of the Phase I clinical trial under this IND and no adverse comments concerning the Phase I results were received from the FDA. Management has made the strategic decision to seek to license the topical line of AVR118 so as to concentrate the Company’s efforts on developing the systemic line. In addition, ADVR also is seeking a marketing partner for the injectable systemic line, with the resources to develop and open the markets for a novel pharmaceutical agent, such as AVR118. The Company has retained GloboMax, LLC, to oversee the development of AVR118. GloboMax managed the IND application for the topical version of AVR118 for the treatment of genital warts (human papilloma virus). Although this first IND refers specifically to the topical use of AVR118, the chemistry, manufacturing and control sections of the application as well as the toxicology section are expected to be major components of IND applications for the injectable uses of AVR118. Israeli Injectable Clinical Studies On November 14, 2002, ADVR announced that it has initiated the single dose safety study, which is the first phase of three AVR118 clinical trials in Israel. The studies inlude: • Phase I/II clinical trial with injectable AVR118 in patients who have failed highly active anti-retroviral therapy (HAART) and require salvage therapy. • Phase I clinical trial for the treatment of body wasting (cachexia) in patients with solid tumors. • Phase I clinical trial for patients with hematopoietic and lymphoid tumors, including acute lymphocytic leukemia, Hodgkin’s disease and non-Hodgkin’s lymphoma, who also manifest symptoms of cachexia. Back to This is ADVR |
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ADVR Begins Planning for Late Stage Phase II AIDS Clinical Trial In
Israel Progress of Current AIDS Trial Leading Selikoff Center to Develop Protocols For Multi-Center, Blinded Controlled Trial YONKERS, N.Y., March 18 /PRNewswire-FirstCall/ -- Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) today announced that, in consultation with the Selikoff Center, it has initiated activities necessary to expand the ongoing Israeli clinical trial of Product R for the treatment of AIDS patients on highly active antiretroviral therapy (HAART). The Company said it has directed the staff of the Selikoff Center in Israel, in collaboration with the principal investigator, to begin developing protocols for a multi-center, late stage Phase II clinical trial of Product R in AIDS patients who are in need of salvage therapy. ADVR said the expanded trial is proposed to be a blinded, controlled trial of Product R in at least 200 patients, including 50 patients in the control group. "The planned expansion of the current trial into a late stage Phase II study is based on the gratifying progress of the current trial in patients with AIDS and the confidence of the clinical investigators in Product R," stated Shalom Z. Hirschman, M.D., President and CEO of ADVR. "I am pleased that the staff at the Selikoff Center and the principal investigator are willing to begin a late Phase II trial as soon as the current clinical trial is completed. By taking these steps now, we will be able to move as rapidly as possible into the next phase of the clinical development of Product R." "We are excited about accelerating our clinical study activities," said Eli Wilner, Chairman of the Board of ADVR. "The completion of the current trials, and the expansion of our activities into a late Phase II comparative trial, move us closer to the ultimate goal of potentially commercializing Product R for illnesses that are inadequately addressed by currently marketed therapies." Currently, the Selikoff Center is conducting a Phase I/II dose escalation clinical trial of Product R in patients with AIDS. The dosages to be used in the late Phase II clinical trial will be based on the final results of the current clinical trial. Status of Clinical Trials in Israel Four medical centers in Israel are now participating in various stages of the three ongoing clinical trials with Product R. Product R is undergoing rigorous clinical testing that primarily should reveal its safety profile and also some of its effects on cachexia in patients with AIDS and patients with cancer, including the effects of Product R on the underlying cancers themselves. Phase I/II study in Cachectic Patients Needing Salvage Therapy for AIDS This clinical trial, a Phase I/Phase II dose escalation study, is being conducted at the Kaplan Medical Center in Rehovot, Israel. In order to preclude problems with patient compliance, that would potentially harm interpretation of clinical data, research nurses go to patients' homes to inject the study patients with Product R six days a week and to conduct clinical interviews with those patients. Study of Treatment of Cachexia (Body Wasting) with Product R in Patients with Solid Tumors This clinical trial is a Phase I dose escalation study preceded by a pre-Phase I single dose safety study. The trial is being conducted at the Chaim Sheba Medical Center in Tel Hashomer, Israel as the principal trial center with a partner center at the Beilinson Campus of the Rabin Medical Center in Petach Tikva, Israel. Study of Treatment of Cachexia with Product R in Patients with Hematopoietic Cancers The objective of this Phase I dose escalation trial is to study the safety of Product R as a treatment of cachexia in patients with hematopoietic cancers, including acute lymphocytic leukemia, multiple myeloma, Hodgkin's disease or non-Hodgkin's lymphoma. The trial also will observe the effects of Product R on the cancers themselves. The principal center for this trial is the Hadassah Medical Center of the Hebrew University School of Medicine in Ein Kerem, Jerusalem with a partner site at the Chaim Sheba Medical Center. The Company currently is attempting to procure the financial resources necessary to both complete the ongoing trials in Israel as well as to pursue the proposed expanded clinical trial. 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. For further information regarding Advanced Viral Research Corp., please visit our website at http://www.adviral.com . 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. 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 Product R 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: Charles Mayr Mayr Communications 877-777-6010 MayrComm@att.net SOURCE Advanced Viral Research Corp. Web site: http://www.adviral.com CONTACT: Charles Mayr of Mayr Communications, +1-877-777-6010,mayrcomm@att.net, for Advanced Viral Research Corp. |
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DR. HIRSCHMAN'S FORUM AN EMERGING NEW FIELD OF PHARMACOLOGY: USE OF IMMUNOMODULATORS TO MITIGATE THE TOXICITY OF OTHER THERAPEUTIC DRUGS Immunomodulator drugs modify the function of the immune system. These drugs have been used to stimulate immune function for the treatment of viral infections and neoplastic diseases. Conversely, immunomodulator type drugs have been used to depress aberrant immune reactions that occur in autoimmune diseases and a variety of infections. Examples include the use of alpha-thymosin for treating hepatitis B virus infection and the use immunomodulators such as Thalidomide and Levamisole to treat immune reactions in patients with leprosy. Advanced Viral Research Corp.'s flagship drug, AVR118, is a peptide nucleic acid-type immunomodulator that can either stimulate the pro-inflammatory responses required to treat viral infections such as AIDS, or dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. During the past three years, it has been noted that in patients with acquired human immunodeficiency syndrome (AIDS), treated with three or more anti-AIDS drugs, toxic reactions to the nucleoside analogs and protease inhibitors appeared to be significantly mitigated by the addition of AVR118 as the immunomodulator. Indeed, patients already suffering toxic reactions to the nucleoside analogs, including nausea, diarrhea, weight loss, muscle wasting, neuropathies, and sleep disorders, experienced a marked amelioration of these toxic effects when AVR118 was added to the therapeutic anti-AIDS regimen. This apparent beneficial effect of AVR118 has allowed patients to be treated with effective doses of the traditional AIDS drugs for prolonged periods of time. Moreover, the absence of the toxicity of the anti-AIDS therapeutic regimen has allowed the patients to live normal, productive lives. This notable effect of AVR118 appears to be an added benefit to the drug's basic therapeutic properties in AIDS patients that include the enhancement of CD4 and CD8 cell counts and reduced HIV viral loads. Laboratory studies have also shown that AVR118 inhibits the production of both the CCR5 and CXCR4 chemokine receptors, the key cellular co-receptors for HIV. The clinical observation that AVR118 may mitigate the toxicity of other anti-AIDS drugs suggests that immunomodulator-type drugs can be used to decrease the toxicity of drugs employed in the therapy of a variety of diseases. These findings also suggests that immune effector molecules, especially chemokines and cytokines, whose synthesis is affected by immunomodulator drugs such as AVR118, play an important role in mediating the toxic effects of many drugs. The promise of using immunomodulator-type drugs for mitigating the toxic reactions of other therapeutic drugs, received scientific support in a recent report by Dr. Rangaswamy Govinbarajan and co-workers published in The Lancet (volume 356:pages 566-567, August 12, 2000). The authors noted that the immunomodulator, Thalidomide, mitigated the gastrointestinal side-effects of the anti-tumor compound, Irinotecan, that is used to treat colo-rectal cancer. Thalidomide, in addition to its sedative effects, has anti-angiogenic and immunomodulatory properties. The drug has been used to treat the immune reactions associated with leprosy and to treat autoimmune symptoms in patients with inflammatory bowel disease. Recently, Thalidomide has been used as an anti-neoplastic drug to treat patients with multiple myeloma and myeloid dysplasia. Thalidomide exerts a variety of effects on immune function. It inhibits tumor necrosis factor-alpha (TNF-alpha) by increasing TNF-alpha mRNA degradation. The drug increases Th-2, and decreases Th-1, immune function by increasing the expression of interleukins 4 and 5 and decreasing the expressions of interferon gamma and interluekin-12. Irinotecan is a DNA topoisomerise-one inhibitor approved for the second line treatment of colo-rectal cancer. Topoisomerases mediate the proper folding and unfolding of DNA. Irinotecan therapy is complicated by severe diarrhea in up to forty percent of patients. The gastrointestinal toxicity of Irinotecan limits its use in most patients. Dr. Govinbarajan and his colleagues found that Thalidomide almost eliminated the therapy-limiting toxic effects of Irinotecan and allowed eight of nine patients to complete the therapeutic chemotherapy course with Irinotecan. The authors speculated that Thalidomide inhibits the calcium and potassium secretion mediated by TNF-alpha either directly or through the inhibition of cyclo-oxygenase. The clinical results observed with the immunomodulator-type drugs AVR118 and Thalidomide open the exciting possibility of using immunomodulator drugs to eliminate the toxic effects of other therapeutic drugs. It should be appreciated that while AVR118 has no apparent toxic side effects, Thalidomide is itself a potentially toxic drug. The severe teratogenic properties of Thalidomide, which caused its removal from the marketplace in 1960 after it was introduced as a sedative in the 1950s, are well known. However, Thalidomide has other toxic effects, especially on the nervous system where neuropathies may suddenly appear and neurologic impairment may be permanent. Many of the antiviral drugs currently used in clinical practice, including the nucleoside analogs used to treat AIDS, and the chemotherapeutic drugs that are used to treat various types of cancer, share a common property in that they interfere with nucleic acid synthesis. Therefore, it is an exciting prospect to investigate the possible role of AVR118 in mitigating the toxic effects of a variety of chemotherapeutic drugs used to treat various types of cancers. If, indeed, AVR118 mitigates the toxicity of anti-tumor chemotherapeutic agents, as it appears to mitigate the toxic effects of antiviral drugs used to treat HIV infection, then the possibility of treating cancer patients with more effective doses of chemotherapeutic agents for longer periods of time holds the promise of significantly increasing the effectiveness of cancer chemotherapy, while dramatically improving the lives of those cancer patients undergoing chemotherapy. This new therapeutic area would represent an unusually large market for immunomodulator drugs such as AVR118 and may, in time, turn out to be the largest market in the history of the pharmaceutical industry. The exciting prospects of using immunomodulator-type drugs for mitigating the toxic effects of drugs that are used to treat a variety of diseases requires much basic scientific research and clinical trials in order to bring this new therapeutic area to practical fruition. Our scientists at The Advanced Viral Research Institute will continue to avidly pursue research in this new field with the objective of using the immunomodulatory properties of AVR118 to enhance the therapeutic effectiveness of anti-tumor chemotherapy and thus improve the clinical outlook and well being of patients. Shalom Z. Hirschman, M.D. Chief Scientist Note: This forum contains forward-looking statements that involve risks associated with clinical development, regulatory approvals (including application to the FDA), product commercialization, risks associated with the conditions precedent to the equity line of credit not being satisfied, and other risks described from time to time in the SEC reports filed by ADVR. AVR118 is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries. Past Forum Articles Back to Scientific Information |
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ADVR's Product R Reverses Cancerous Properties of Human Promyelocytic
Leukemia Cells in Laboratory Cultures Findings Presented at Meeting of the American Association for Cancer Research Show That Product R Induces Differentiation of a Human Promyelocytic Leukemia Cell Line YONKERS, N.Y., Oct. 11 /PRNewswire-FirstCall/ -- Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) today announced that the Company's peptide nucleic-acid immunomodulator, Product R, induces differentiation of the human promyelocytic leukemia cell line HL-60 in cell culture. These research findings are being presented today at a conference of the American Association for Cancer Research (AACR) entitled, "Proteases, Extracellular Matrix and Cancer", held in Hilton Head Island, South Carolina. A prime property of cancers cells, such as leukemia cells, is that they exhibit undisciplined or "wild" growth patterns. Cancer cells are often termed as being "undifferentiated." Normal or "differentiated" cells exhibit orderly growth patterns, subject to the normal controls of cellular growth. Drugs that induce cellular differentiation and maturation, such as tretinoin, currently are utilized to treat promyelocytic leukemia. "These exciting research findings suggest the potential of new cancer treatments with Product R. Moreover, these findings complement our clinical trial in Israel of Product R in patients with hematopoietic cancers," said Shalom Z. Hirschman, M.D., President and CEO of Advanced Viral Research Corp. "The use of targeted agents to induce the differentiation of cancer cells -- that is, to reverse the unruly growth of cancer cells -- is a relatively new field of cancer therapy with a growing market. These new research results indicate that Product R should be studied clinically for utilization in this type of cancer therapy." "Our teams of scientists continue to produce research results that point to new potential therapeutic uses of Product R," stated Mr. Eli Wilner, Chairman of the Board of Advanced Viral Research Corp. "These results expand the horizons of Product R in cancer therapy." To determine whether Product R induces differentiation of promyelocytic leukemia cells, scientists at Advanced Viral Research Corp. tested the effects of this drug on HL-60 cells, a promyelocytic leukemia cell line that has the ability to differentiate toward granulocytes or monocytes in cell culture. When undifferentiated HL-60 cells were cultured in the presence of Product R, it was found that Product R inhibited cell growth and induced cell differentiation, as measured by the expression of characteristic cell surface markers of cellular differentiation such as CD-14 and CD-35. Product R also stimulated the expression of other markers of cellular differentiation, resulting in functionally more mature cells. Product R Clinical Studies Phase II U.S. Study In 2001, ADVR submitted to the FDA an IND for the topical treatment of genital warts, and a Phase I safety study has been completed successfully in healthy volunteers with the current liquid formulation. In April 2002, the Company announced that it had submitted to the FDA the results of this Phase I trial, and that the FDA had made no adverse comments concerning the Phase I results. The Company is now beginning the process of recruiting clinical sites in the United States to perform Phase II clinical trials with Product R in patients with genital warts. During the course of Phase II, the efficacy of Product R for the topical therapy of genital warts will be investigated in various doses. Due to limited financial resources, the Company has not yet secured clinical sites nor has it made any material progress on the Phase II clinical trials. Israeli Clinical Studies In June 2002, ADVR announced that it had received approval from the Ministry of Health for three clinical studies in Israel. The three trials include a Phase I/Phase II clinical trial with injectable Product R in cachectic AIDS patients who have failed highly active antiretroviral therapy and require salvage therapy; a Phase I clinical study for the treatment of body wasting (cachexia) in patients with solid tumors; and a Phase I clinical trial in cachectic patients with hematopoietic and lymphoid tumors, including acute lymphocytic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma, who also manifest symptoms of cachexia. The Company recently secured funds to commence these clinical trials; however, additional financing to continue or complete subsequent clinical trials may not be available to us, which may force us to curtail our operations by, among other things, limiting our clinical trials for Product R. Recent Appointment Advanced Viral Research Corp. recently announced the appointment of Dr. Richard S. Kent to the Board of Directors. Dr. Kent was previously Senior Vice President of Global Medical Affairs and Chief Medical Officer for GlaxoSmithKline (NYSE: GSK). Dr. Kent brings nearly two decades of global pharmaceutical industry experience to the Company. ADVR's 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, Product R has been termed a "switch-type" immunomodulator. Product R is also being studied for the promise shown in its ability to mitigate the toxic side effects of other drugs, including those used to treat HIV infection and chemotherapeutic drugs employed in the treatment of cancers. 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. For further information regarding Advanced Viral Research Corp., please visit our website at http://www.adviral.com. 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. 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 Product R 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: Charles Mayr Mayr Communications, Inc. 877-777-6010 mayrcomm@att.net Make Your Opinion Count -- Click Here http://tbutton.prnewswire.com/prn/11690X33845275 SOURCE Advanced Viral Research Corp. Web site: http://www.adviral.com CONTACT: Charles Mayr of Mayr Communications, Inc.,+1-877-777-6010, or mayrcomm@att.net, for Advanced Viral ResearchCorp. |
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Some ADVR History By: 0roadrunner 25 Nov 2003, 07:38 PM EST Msg. 126894 of 129299 ADVR History: Here's a collection of articles, links and posts which I find significant. There's much information in these links and a great source for DD. Just keep in mind that while some of the links contain older information, the drug is one and the same. The best place for updated info is adviral.com of course. I may post this list from time to time as more new posters appear on this board. Product R: The drug they called miraculous http://ragingbull.lycos.com/mboard/boards.cgi?board=ADVR&read=111732 Old Drug, New Hope Used in WWII, immune-system booster is now tested in AIDS fight http://ragingbull.lycos.com/mboard/boards.cgi?board=ADVR&read=111724 The Magic Bullet http://ragingbull.lycos.com/mboard/boards.cgi?board=ADVR&read=111544 Everything that's old is new again; unique pharmacologic class 'discovered' http://ragingbull.lycos.com/mboard/boards.cgi?board=ADVR&read=109550 ADVR as "Amgen of the 21st century" (this post is from ShaggyDogs and is one of my favorites) http://ragingbull.lycos.com/mboard/boards.cgi?board=ADVR&read=121498 Audio Progress Report (search for ADVR) http://www.macreport.net/ Blockbuster drugs: Take the hype in small doses (note: no ADVR mention, but an excellent article) http://ragingbull.lycos.com/mboard/boards.cgi?board=ADVR&read=109495 Read More: http://www.adviral.com/ADVR/index.htm |
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AVR118 FREQUENTLY ASKED QUESTIONS • What is it? • What does it do? • How does it do this? • Is it a new idea? • Is it patent protected? • Has it been tested in people? • What are the results? • Is it safe? • What is your strategy? • What will this cost? • When will the results of the Israeli studies be available? • What is the competition? • Return on Investment What is it? Peptide Nucleic Acid AVR118 belongs to a new class of compound – a peptide nucleic acid. back to top What does it do? Immunomodulation It is an immunomodulator which can turn on the immune system to mount a proinflammatory response as is needed to treat viral infections or cancers or in aberrant situations where the immune system is overactive, such as occurs in autoimmune diseases like rheumatoid arthritis, it can switch it off. back to top How does it do this? Novel Mechanism of Action It interacts with receptors on cell surfaces to switch them on or off. In addition it stimulates the production of chemical messengers which can stimulate the immune system. back to top Is it a new idea? Based on Long Established Concepts The idea of stimulating the immune system is not new. In fact a forerunner product – Reticulose, which was a mixture of peptides and nucleic acids was used successfully in the USA until the 1960’s. AVR118 however, is new; it is a well-characterized drug that contains a unique peptide nucleic acid. back to top Is it patent protected? U.S. Patent Protected It is protected by U.S. Patent No. 6,303,153, seven other issued patents and 20 patent applications. back to top Has it been tested in people? Human Data Available A double-blind placebo controlled clinical trial was conducted at the University Hospital in Barbados. A Phase I clinical trial on the topical treatment of genital warts has been conducted in the United States. back to top What are the results? Evidence of Safety, Efficacy The double-blind placebo controlled study in HIV/AIDS patients in Barbados showed increases in well-being, weight and CD4 count in the group treated with AVR118. The Phase I clinical trial for the topical treatment of genital warts has been completed under an FDA IND in the U.S. Overall results of the Phase I clinical trial indicate that AVR118 was safe and well tolerated dermatologically in all the doses applied in the study. back to top Is it safe? Excellent Tolerance Toxicology studies in animals suggest it is apparently non-toxic. Excellent tolerance has been observed in patients. back to top What is your strategy? A Candidate for Partnership Our plan is to develop AVR118 to a stage where it will be attractive as a licensing candidate to a large pharmaceutical company. So far we have had an IND for topical application to genital warts approved in the USA and have successfully completed a safety study in volunteers. An initial efficacy study in genital warts is planned. We have received approval from the State of Israel to begin 3 safety/initial efficacy studies in patients suffering from body wasting (cachexia) and a) solid cancerous tumors, or b) leukemias/lymphomas, or c) AIDS not adequately responding to antiviral drugs. back to top What will this cost? $6 Million First Year Development Program The first year costs of the clinical program described above are expected to be approximately $6 million. back to top When will the results of the Israeli studies be available? Results Expected Within 12 Months of the Start of the Study We expect to begin the studies as soon as the funding is produced and anticipate the completed results within 12 months. back to top What is the competition? More Effective Treatments for Cachexia Are Needed Megace (BMS) and human growth hormone (Serono) are indicated for the treatment of cachexia associated with AIDS. However, many physicians consider that current treatments are inadequate. back to top Return on Investment Returns on Investment Are Dependent Upon the Clinical Efficacy of the Drug. The historical investment patterns of biotechnology companies have been that multifold returns are achieved when companies progress from the development stage to completed Phase II clinical trials. back to top Please click here to download this information sheet. PDF Format - 16KB Note: This fact sheet 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 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. Back to Investment Information |
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ADVR Reports Positive Preliminary Results of AVR118 Clinical Trial in
AIDS Patients Suffering from Body Wasting (Cachexia) Monday November 10, 8:21 am ET Patients Show Improved Appetite, Weight Stability or Gains, and Enhanced Quality of Life YONKERS, N.Y., Nov. 10 /PRNewswire-FirstCall/ -- Advanced Viral Research Corp. (OTC Bulletin Board: ADVR - News) today reported that preliminary results from the first 15 cachectic (wasting) AIDS patients treated with the Company's novel immunomodulator AVR118 showed improvement in appetite, weight gain or stability, and enhanced quality of life in all the patients. None of the 15 patients reported any significant side effects from AVR118 (formerly known as Product R) therapy. Cachexia is a state of body malnutrition and wasting with loss of body fat and lean body weight. Choose loan type: New MortgageRefinanceHome Equity The 15 patients who completed the trial included eight males, five on highly active antiretroviral therapy (HAART), and seven females, five of whom were receiving HAART. The primary indication of the trial is the treatment of cachexia (body wasting). The patients are part of a Phase I/Phase II open- label dose escalation clinical trial being conducted at The Kaplan Medical Center in Rehovot, Israel. "We have taken the unusual step of publicizing these preliminary results, despite the small population of patients, because of the apparent strong clinical results demonstrated, even in this short course treatment protocol, by AVR118 in these very ill patients," said Eli Wilner, Chairman of the Board of ADVR. "If the continuation of the study confirms these preliminary findings, the value of AVR118 in treating body wasting in AIDS patients will merit much broader scientific analysis in a large study of AIDS patients." "These preliminary results are very encouraging because a positive clinical effect was seen in virtually all patients following initiation of treatment with AVR118, even at the lowest dosage," said James D'Olimpio, M.D., Director of the North Shore University Hospital's Supportive Oncology and Palliative Care Service, and a member of ADVR's Scientific Advisory Board. "The study design and quality of data is worthy of a presentation at an appropriate international scientific meeting. I would encourage the investigators to prepare an abstract once the statistical analysis of the data set is completed so that these promising preliminary results can be shared with the global scientific community." Dr. D'Olimpio has done extensive research on cachexia, particularly in cancer patients. When completed, the clinical trial will include a total of 30 patients, with 10 each receiving AVR118 administered subcutaneously per day at the three doses of 0.4 ml, 2 ml, and 4 ml. The trial protocol specifies a two-week preliminary observation period followed by four weeks of AVR118 therapy and four weeks of observation. "The preliminary results demonstrate the potential utility of AVR118 in this group of patients," said Richard A. Guarino, M.D., ADVR's clinical and regulatory advisor. "These preliminary results in cachectic AIDS patients are encouraging, and I eagerly await possible confirmation of our preliminary results once all 30 patients have completed the trial," said Shalom Z. Hirschman, M.D., ADVR's Chief Scientist. "These results garnered midway through the clinical trial appear to validate our expectations of the clinical activity of the unique immunomodulator AVR118." 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 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: Eli Wilner 914-376-7383 |
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Corporate Overview Advanced Viral Research Corp. (OTCBB:ADVR) is a biopharmaceutical company committed to researching, developing and bringing to market new therapies for viral and other diseases. Founded in 1984, the Company has headquarters in Yonkers, New York. The approximately 17,650 square-foot complex includes executive offices, research laboratory space and a production facility designed to manufacture pharmaceuticals to cGMP standards. Advanced Viral’s principal pharmaceutical product, Product R, represents a new type of biopolymer chemistry that also possesses novel immunomodulator activity. This non-toxic 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. Therefore, Product R has been termed a “switch type” immunomodulator. Product R is being studied for the promise shown in its ability to mitigate the toxic side effects of other drugs (including those used to treat HIV infection and chemotherapeutic drugs employed in the treatment of cancers); for its ability to stimulate the immune system to attack tumor cells (especially those cancer cells that have been damaged by chemotherapeutic agents): and for its ability to treat cachexia (wasting) in patients with AIDS or cancer. [Back to Top] Corporate News ADVR Is Assigned Ownership of Two U.S. Patents in Settlement of Litigation ADVR's Product R Reverses Cancerous Properties of Human Promyelocytic Leukemia Cells in Laboratory Cultures ADVR Granted Therapeutic Composition Patent For Product R; U.S. Patent Awarded for Chemical Structure of Novel Peptide Nucleic Acid ADVR Begins Phase 2 of IND for Topical Treatment Of Genital Warts With Product R Advanced Viral Research Corp. Submits Product R Topical Phase 1 Results to FDA Advanced Viral Research Corp. Forms Scientific Advisory Board with Leaders in Oncology, Hematology, Women's Health Care ADVR Files Stock Manipulation Suit in Florida ADVR Begins Product R Israeli Clinical Trials; Quintiles Retained to Monitor/Audit Trials, Selikoff Center to Conduct Trials Dr. Sidney Pestka Joins ADVR Scientific Advisory Board ADVR Announces Completion of $3 Million Financing; Funds Enable Israeli Clinical Trials of Product R to Move Forward ADVR Announces $1.5 Million Investment By Member of Board and Member of Business Advisory Board ADVR's Product R Approved in Israel for Phase I Study In Patients with Solid Tumors ADVR's Product R Approved in Israel for Phase I Study in Leukemia and Lymphoma Patients ADVR's Product R Approved in Israel for Phase I/II Study In Patients Needing Salvage Therapy For AIDS ADVR Reports AVR118 Inhibits Inflammatory Arthritis in Animal Model and in Rheumatoid Arthritis Patients in Human Clinical Trial ADVR's AVR118 Granted a Patent in China for the Treatment of AIDS Advanced Viral Research Corp. Announces Retention of James T. D'Olimpio, MD As 'Spokesperson at Large' ADVR Reports Positive Preliminary Results of AVR118 Clinical Trial in AIDS Patients Suffering from Body Wasting (Cachexia) ADVR CEO Hirschman Comments on SARS on ABC World News Tonight ADVR Begins Planning for Late Stage Phase II AIDS Clinical Trial In Israel ADVR Announces Staff Reduction to Conserve Capital to Focus on Israeli Clinical Trials; Intent to Sell Bahamas Plant; Board Resignations Dr. Richard S. Kent Joins ADVR Board of Directors ADVR's Product R Subject of Published Study on Clinical Trial For Treatment of HIV/AIDS Paul R. Bishop Joins ADVR Board of Directors Roy S. Walzer Joins Board of Directors of Advanced Viral Research Corp. ADVR's Product R Granted Patent for Topical Use In Treatment of Skin Diseases, Eye Afflictions [Back to Top] Analyst Reports Unavailable [Back to Top] Technology & Key Products PRODUCT R Product R represents a new type of biopolymer chemistry that also possesses novel immunomodulator activity. This non-toxic 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. Therefore, Product R has been termed a “switch type” immunomodulator. Product R is being studied for the promise shown in its ability to mitigate the toxic side effects of other drugs (including those used to treat HIV infection and chemotherapeutic drugs employed in the treatment of cancers); for its ability to stimulate the immune system to attack tumor cells (especially those cancer cells that have been damaged by chemotherapeutic agents) and for its ability to treat cachexia (wasting) in patients with AIDS or cancer. - Advanced Viral has a patent on the preparation of a therapeutic composition of Product R. - Product R belongs to the chemical class of peptide nucleic acids (PNAs). - Advanced Viral holds nine patents related to Product R that cover such uses as: the topical treatment of skin disease and eye afflictions including genital herpes and shingles; treatment of basal cell carcinoma; treatment of anemia associated with chronic renal failure, chemotherapy and HIV therapy; combination therapy for HIV; treatment of lupus; and treatment of rheumatoid arthritis. - In addition to issued patents, Advanced Viral has applications for approximately 20 additional patents related to Product R, and continues to submit applications for additional patents as appropriate. The Company is currently targeting therapeutic uses of Product R that may allow the Company to take advantage of FDA programs for accelerated drug approvals. [Back to Top] Institutional Ownership Unavailable [Back to Top] Alliances Unavailable [Back to Top] BioBN Stock Watch Gerard Puorro President & CEO Candela Corporation NASDAQ:CLZR Peter Savas President & CEO Aderis Pharmaceuticals Private [More...] Breaking News Dec 29, 2003 05:05 PM PNAS Study from BioMarin Highlights Possible New Approach for Improving the Efficacy of Enzyme and Protein Replacement Therapies... Dec 29, 2003 04:28 PM Appeals Court Rules in Pfizer's Favor in Patent Case... Dec 29, 2003 04:26 PM Watson Pharmaceuticals Launches TriNessa(TM) Oral Contraceptive... Dec 29, 2003 01:48 PM Barr Launches Generic Version of Ortho Tri-Cyclen(R) Tablets... Dec 29, 2003 12:33 PM John J. 'Jack' Dolan Named Eastern Regional Sales Executive For PacifiCare Behavioral Health... Dec 29, 2003 11:55 AM Amgen Named One of Fortune Magazine's '100 Best Companies to Work For'... Dec 29, 2003 09:32 AM Strategika, Inc. (d.b.a. Tiens Biotec Group (USA), Inc.) Files Application for Listing on Amex... Dec 29, 2003 09:00 AM CompuMed, Inc. Announces Fiscal 2003 Year-End Financial Results... Dec 29, 2003 08:01 AM Aventis Submits New Drug Application With U.S. Food and Drug Administration For Once Daily Formulation of Allegra-D(R) (fexofenadine HCl 180 mg/pseudoephedrine HCl 240 mg)... Dec 29, 2003 08:01 AM Immunomedics Publishes Successful Results With New Cancer Therapeutic... [More...] Disclaimer BioBusiness Networks Corporation All Rights Reserved. ©2001-2003 |
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Cyber.. first let me say pink sheets do not require reporting. otc bb
does. in answer to question 2... the product is a non-toxic form of a
PNA. this makes it unique. Question 3. This is the most difficult. The co is reported to be in negotiation with a bio co. Why most bio co don't get in line to do business for this product is hard to understand.. It might be because this product would relieve too many products now being sold and cause a net reduction in profits. Ur guess is as good as mine. - - - - - View Replies » |
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for the record regarding a sale of company shares under the "Hirschman
Consulting Agreement dated May 1995" and "as of September 30, 1997." according to the 10-QSB filed with the securities and exchange commission for the period above: "As of September 30, 1997, 900,000 shares have been issued upon exercise of these options for cash consideration of $162,000.00 under this agreement." the value of that exercise was $0.18 per share with proceeds to the company for $162,000.00. this is rather simple to understand and has nothing to do with loans. for the nine months ending 9/97, the cash and cash equivalents ending is $231,515.00 I hope this well help j150 and kevtod with all their yanking. After a few hours to reconfirm what I know i did consider providing a link but with all the bad flavor their fingers can do the walking. I think this will erase any blabber on this issue and I was glad to help out. it is sad to see such repulsive behavior regarding positive input on poor information. thx again. |