Amerimmune Completes Phase Ia Human Safety Trial for Monoclonal Antibody HIV Treatment.Business Editors & Health/Medical Writers WOODLAND HILLS, Calif.--(BW HealthWire)--Nov. 29, 2001 Amerimmune Pharmaceuticals Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :AMUN), a pharmaceutical research company that is developing Cytolin(R), a revolutionary treatment for patients suffering from human immunodeficiency virus human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. (HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. ) and Acquired Immune Deficiency Syndrome Acquired immune deficiency syndrome (AIDS) A viral disease of humans caused by the human immunodeficiency virus (HIV), which attacks and compromises the body's immune system. (AIDS), today announced the completion of its Phase Ia human safety trial for an intravenous formulation of the murine murine /mu·rine/ (mur´en) pertaining to, derived from, or characteristic of mice or rats. mu·rine adj. monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing . The Phase Ia study, conducted in 13 subjects suffering from HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome , found Cytolin(R) to be safe and well tolerated across a narrow dose range. The initial safety study, which consisted of two single escalating doses of 0.05mg and 0.1mg/kg body weight, affirmed the safety and tolerability of the drug in these lower dose groups with no serious or severe adverse events reported. "We are pleased with the continuing progress of Cytolin(R) in the clinical setting," said Donald W. Northfelt, M.D., F.A.C.P., Assistant Clinical Professor of Medicine at the University of California, San Diego UCSD is consistently ranked among the top ten public universities for undergraduate education in the United States by U.S. News & World Report.[3] It is a Public Ivy. [1] For graduate studies, most of UCSD's Ph.D. and principal investigator for the Phase Ia trial. "We look forward to examining safety results at higher dose levels and, ultimately, generating efficacy data." About Cytolin(R) Cytolin(R) is a patented monoclonal antibody that blocks certain adhesion molecules on one of the disease-fighting cells of the immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. , thereby protecting the immune system from "killer-type" T cells that tend to turn the human immune system against itself. By helping to shore up the immune system's natural defenses, Cytolin(R) is a distinctly different therapeutic approach from antiviral drugs (e.g., reverse transcriptase inhibitors and protease inhibitors), which take the offensive against the virus. Amerimmune is engaged in pharmaceutical research and development with the primary purpose of developing Cytolin(R), a drug designed to protect the immune system, especially in patients suffering from human immunodeficiency virus (HIV). The company believes that Cytolin(R) is an important drug for the growing number of patients who have not been receiving treatment, for those who are on multi-drug therapy and for those who have become resistant to drugs currently used to treat the HIV/AIDS virus. For more information, visit the company's Web site, www.amerimmune.com. Statements made in this news release that are not historical facts, such as anticipated results of clinical trials, may constitute "forward-looking statements," which are made pursuant to the safe harbor provisions in the federal securities laws. Forward-looking statements are subject to risks, uncertainties and other factors beyond the control of the company that could cause actual results to differ materially from those from those set forth in, contemplated by, or underlying the forward-looking statements. Factors that could cause actual results to differ materially from the company's expectations are detailed in the company's filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K. The company disclaims any obligation to revise any forward-looking statements to reflect events or circumstances after the date of such statement or to reflect the occurrence of anticipated or unanticipated events. |
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