Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Monday, 7 October 1996
HRG214 is formulated as an immunochemically engineered group of antibodies which neutralize and inactivate essential steps in the life cycle of HIV. HRG214 is the first immunology based pharmaceutical to show successful treatment of HIV infection. When HRG214 is used in conjunction with two additional drugs, one to initiate and one to control cytokine pathways, (the chemical signals by which cells communicate), CD8 lymphocytes and other cells which fight infection, (present but not functioning normally in AIDS patients), are rapidly restored to normal function. This drug regime opens new therapeutic options for the care of HIV patients, including those in advanced stages of AIDS.
When HRG214 was administered daily over a 28-day period to patients with advanced stages of AIDS, significant reductions in the level of HIV-RNA and HIV infectivity, and improvements in opportunistic infections were observed. These improvements, without retreatment, have remained in some patients up to six months.
However, in additional studies where advanced AIDS patients were treated daily for 28 days with HRG214 and with the cytokine regime, and retreated monthly on three consecutive days each month, the patients sustained the reductions in the level of HIV-RNA (90%) and HIV infectivity (over 99%), with improvements in immune function, and resolution of opportunistic infections. There have been no mortalities in this group and all have remained asymptomatic for fifteen months.
In addition, CD4 and CD8 lymphocyte numbers have statistically increased, and marked clinical improvements have been observed in all patients receiving this retreatment regimen with HRG214. These improvements include increase in appetite and stamina, as well as marked improvements in AIDS-related conditions such as chronic fatigue syndrome, diarrhea, malabsorption, candidiasis, wasting syndrome, pneumonitis, molluscum contagious, HIV-related peripheral neuropathy, and other HIV-related diseases.
Five patients with CD4 numbers between 300 and 500 were treated with HRG214 for 28 consecutive days without retreatment but followed monthly. All five patients have sustained reductions in HIV-RNA and HIV infectivity with a sustained improvement in immune function and CD4 lymphocyte number. In this group, these improvements have sustained for up to two years without evidence of disease progression. All five of these patients have demonstrated increases in cytotoxic lymphocyte activities in killing HIV infected cells and antibody reactivities to HIV proteins which were not detected in blood samples obtained prior to treatment. There is insufficient data at this time to determine if these changes are a result of immune events which are associated with the interaction between the antibodies in HRG214 and resulting in new immunity, or a return of immunological memory with responses acquired earlier, following infection with HIV.
The medication is manufactured by Cervida Corporation Ltd., a New Zealand- owned and operated biotechnology and pharmaceutical company. Government approvals to conduct trials with HRG214 have been obtained in Mexico, Thailand, and the Republic of Georgia. Requests for approval are pending in Europe and an application for approval by the United States Food and Drug Administration (FDA) will be filed in the near future. The results of HRG214 studies are being presented by Dr. Frank Gelder at the First Joint Meeting of the International Cytokine Society and International Society for Interferon and Cytokine Research on October 8, in Geneva, Switzerland. Among the scientists involved in the project are Dr. Wayne Watkins, Professor, University of Auckland, New Zealand; Dr. Jerzy Georgiades, former Professor, University of Texas Medical School Galveston, Texas, and president of the Georgiades Foundation; Dr. Joel Rodriguez Sierra, former dean of the medical school at the University Valle Del Bravo, Renosa, Mexico; Dr. Anna Inglot and her associates, Professor of Medicine, Department head of the Institute of Virology and Experimental Therapy, Polish Academy of Science, Wroclaw, Poland; and Dr. J.D. Dixon, Purification Systems, Inc., Brookline, Massachusetts. It is the goal of the international scientific team and the investment group working on the HRG214 project to make the medication available on a world wide basis at minimum cost to the patients.
Dr. Gelder is the inventor of HRG214 and holds a U.S. patent for the purification and use of cold insoluble globulin which was assigned to New England Nuclear Corporation of Boston, Mass., now Dupont. He was principal investigator of Pancreatic Oncofetal Antigen Measurements in Pancreatic Cancer for Smith-Kline Laboratories from 1987-1994. He is the author of almost 100 journal articles, book chapters and abstracts, and has been a presenter and participant at 43 professional meetings and conferences worldwide and is on the faculty of Louisiana State University Medical Center in Shreveport, Louisiana.
CONTACT: George H. Mills, Mills, Timmons & Flowers, 318-222-0337, for Louisiana State University Medical Center/ 09:04 EDT
Copyright (c) 1996/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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