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| 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. E-mail this page to a friend or colleague! To print, use this version Any question regarding a medical diagnosis, treatment, referral, drug availability or pricing should be directed to either a licensed physician or to the product's manufacturer. If you have any technical questions or other concerns about this site, feel free to contact us at webmaster@docguide.com. All contents Copyright (c) 1995- Doctor's Guide Publishing Limited. All rights reserved. Employment opportunities | Partnering opportunities |
| Clinical
Trials Data Data from a double-blind study of 43 AIDS patients were presented at the American Society for Microbiology's Annual Meeting in 1998. The presentation was entitled, "Controlled Trial of a New Non-Toxic Drug, Reticulose, in the Treatment of Patients with HIV/AIDS." It included data that Product R can stimulate the immune system to produce increased CD4 and CD8 positive cells and an accompanying downward trend in HIV viral load. The patients in the Product R group also gained weight and experienced an improved clinical condition, compared with the control group. The study took place at the Queen Elizabeth Hospital, University of West Indies School of Medicine in Barbados. The principal investigators were Henry Fraser, M.D., chairman of the department of medicine and clinical pharmacology, and Paul Levett,Ph.D., a microbiologist and former chair of the World Health Organization's Committee on Leptospirosis. AIDS Genotyping Study Currently, a team of research scientists, led by Dr. Paul Levett, is conducting an HIV genotyping study of the 43 AIDS patients who participated in the Barbados-based clinical trial. Data from these patients are being compared with those from with a control group. If the data show that "Product R" interferes with the virus' mutation or resistance to treatment, then this will provide a possible mechanism for the enhancement by Product R of the efficacy of HAART (highly active antiretroviral therapy) in AIDS. The scientists expect to publish results in peer-reviewed journals when the study is completed. AIDS Case Studies ADVR presented case studies of AIDS patients treated with Product R at a recent conference on chemokines and chemokine receptors. Both patients in this case study presentation were initially unable to tolerate, and subsequently failed, the AIDS cocktail (HAART). When treated with a combination of Product R and HAART, however, both experienced a dramatic drop in viral loads, increases in weight and CD4 positive cell counts, and improved quality of life. Human Papilloma Virus Data Advanced Viral Research Institute laboratory research indicates that Product R interferes with the expression of the E7 oncogene of HPV-18. Production of the E7 protein is important in malignant transformation and development of cervical cancer. about ADVR - corporate update - in the news - pharmaceuticals - career opportunities - financial info - contact ©2000 Advanced Viral Research Corp. All rights reserved. Terms & Conditions |
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| CORPORATE
UPDATE -- APRIL 2002 The first quarter of 2002 has seen our efforts to develop Product R gain additional momentum. I am pleased to report that Advanced Viral Research Corp. realized several key milestones since our year-end corporate update. These milestones include: submission of completed Phase 1 results for our topical IND to the FDA; being awarded a patent for the «Topical Treatment of Skin Disease and Eye Afflictions» for Product R; receiving approvals from the Helsinki Committees (Institutional Review Boards) for three Phase 1 clinical trials for the systemic use of Product R in Israel; initiating production of clinical batches of Product R at our Yonkers facility; and, making progress in animal model development at the Weizmann Institute. settlement of the litigation between Advanced Viral Research Corp. and Commonwealth Pharmaceuticals, Ltd. and other defendants. Phase 1 Results Submitted; Phase 2 Protocol Prepared In March, Advanced Viral Research Corp. submitted the results of a Phase 1 study for the topical use of Product R in the treatment of genital warts caused by infection with the human papilloma virus (HPV) to the U.S. Food and Drug Administration (FDA). Overall results of the Phase 1 clinical trial indicate that Product R was safe and well tolerated dermatologically in all the doses applied in the study. At any given time, an estimated 20 million people in the United States have genital HPV infection. Advanced Viral believes there is a need for more effective and better-tolerated therapeutic options. The Phase 1 trial was a placebo-controlled, open-label, single-center dose escalation study in 30 healthy volunteers. There were no serious dermatologic adverse events observed in this Phase 1 study. The data accrued in the Phase 1 study form the basis for the Phase 2 protocol which is under review by the Company and its FDA consultants, Globomax, LLC. Patent Awarded for New Uses Also in March, the Company was awarded U.S. Patent No. 6,355,226 entitled «Topical Treatment of Skin Disease and Eye Afflictions.» The patent protects the use of Product R, the non-toxic peptide-nucleic acid immunomodulator being developed by Advanced Viral, for use in the topical treatment of skin diseases and eye afflictions. Helsinki Committees Approve Proposed Phase 1 Trials of Injectable Product R in Israel Advanced Viral Research Corp. recently received approvals from the Helsinki Committees (Institutional Review Boards) for three Phase 1 trials that we expect to conduct at major Israeli academic medical centers in the near future. We now await final approvals from the Ministry of Health. These three trials have been designed to yield data on safety and effects of injectable Product R on cachexia (body wasting), patient's well-being and quality of life, and the cancers themselves. The data from these trials are expected to meet the rigorous standards required by the U.S. Food and Drug Administration (FDA). The proposed clinical trials address uses of Product R in potentially large therapeutic categories: Phase 1 trial of the use of Product R to treat cachexia (body wasting) in patients with neoplasias of lymphocytic cells, i.e., acute lymphocytic leukemia, Hodgkins lymphoma, and non-Hodgkins lymphoma. Phase 1 trial of the use of Product R to treat cachexia in patients with solid tumors such as cancers of the colon, kidney, lung and breast. Phase 1 trial of the use of Product R as salvage therapy in patients with AIDS who have failed highly active anti-retroviral therapy (HAART). In this trial Product R will be used in combination with HAART. The trials, which were designed in a collaboration between Selikoff clinical investigators and Globomax, LLC, our FDA consultants, are expected to yield information that will assist us in the design of Phase 2 trial protocols for both the U.S. and Israel. The Company anticipates that the data from the clinical trials in Israel may also facilitate discussions with other pharmaceutical companies. Production Begins in Yonkers We have begun producing clinical batches of Product R for systemic use at our Yonkers, New York facility. At present, the Yonkers facility mirrors the production process used in the Freeport facility to produce Product R. The Yonkers facility is designed to produce Product R for injection that meets FDA cGMP standards and the output of this facility will support the clinical trials of the systemic uses of Product R. The Weizmann Institute Model Development Progresses Researchers at the Weizmann Institute in Rehovoth, Israel have demonstrated that Product R inhibits the development of arthritis and encephalitis in rat models of adjuvant arthritis and experimental allergic encephalitis, respectively, when Product R is administered at the same time as the inflammatory stimulus. These models of the dampening effects of Product R on autoimmune reactions are being fine-tuned and studies of possible molecular mechanisms of the actions of Product R are to follow. The animal models serve as experimental prototypes for the study of autoimmune disorders, such as rheumatoid arthritis. Institute researchers also propose to investigate other animal models, including a graft rejection model and tumor growth and tumor metastasis models, for the immunomodulatory effects of Product R. These investigations may be important for the future positioning of Product R in the pharmaceutical marketplace. Litigation Settlement On November 8, 2001, the U.S. District Court for the Eastern District of Michigan dismissed with prejudice all of the claims of the Defendants. In connection with its dismissal order, the U.S. District Court further held that the Company is the exclusive owner of all Reticulose® technology. In connection with the Company's counterclaims against the Defendants, on March 20, 2002, the Company and the Defendants entered into a Settlement Agreement in settlement of the Company's claims against Defendants. The Settlement Agreement was entered as part of the final judgment of the District Court on March 25, 2002, and all remaining claims were dismissed. The Settlement Agreement provided, among other things, that: the Defendants acknowledged that the Company is the sole and rightful owner of all rights, title and interests for the United States and throughout the world in and to the Reticulose® technology; the Defendants sold, assigned and transferred, jointly and severally, to the Company, its successors and assigns, all their claims, rights, title and interests for the United States and throughout the world in and to Reticulose®, the Reticulose® trademark, the Reticulose® technology, any modifications, improvements or derivations thereto, and all related patents, inventions, discoveries, currently pending patent applications and any patents, discoveries and inventions resulting therefrom or described therein, free and clear from any encumbrance whatsoever; the Company granted IMMC, a non-exclusive, non-transferable, royalty-free license to make, use and sell products coming within the scope of the patents transferred by the Defendants to the Company, but only to the extent such products are in the form of oral dietary supplements which were already being sold on IMMC's then current website; Defendants agreed to indemnify, hold harmless and reimburse the Company from and for any and all liabilities arising from the manufacture, distribution, marketing, sale or use of any of IMMC's products; and The Defendants agree not to advertise or publicize that there is any connection between any of Defendants' products and the Company, its predecessors or Reticulose®, nor will it copy, distribute or publicize, orally or otherwise, any data obtained by or produced on behalf of the Company or any of its predecessors relating to Reticulose® or any other product of the Company as if the data were developed by or for Defendants or was derived from product of any of the Defendants, and such data shall be returned to the Company to the extent it is in the possession of the Defendants. Summary Advanced Viral Research Corp. continues to make progress in the development of Product R for a number of important of applications. We are focused on being prepared to realize the full potential of this novel immunomodulator in significant therapeutic areas. To ensure that we develop Product R as efficiently as possible, we are committed to following all scientific pathways in a rigorous manner. While this process takes time, we believe that it will form the foundation for the successful commercialization of Product R. We thank our shareholders for their patience and steadfast support of our efforts. Shalom Z. Hirschman, M.D. President & CEO Note: The information contained herein 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 complete the clinical trials of Product R. 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 Information: Charles Mayr Mayr Communications, Inc. 400 Rt. 17 South Ridgewood, NJ 07450 tel: 877-777-6010 fax: 201-612-6013 mayrcomm@att.net Previous Update about ADVR - corporate update - in the news - pharmaceuticals - career opportunities - financial info - contact ©2001 Advanced Viral Research Corp. All rights reserved. Terms & Conditions |