ImmuCell announces alliance to further develop antibody product against cryptosporidiosis.PORTLAND, Maine--(BUSINESS WIRE)--March 26, 1996--ImmuCell Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ICCC ICCC International Council for Caring Communities ICCC International Council for Computer Communication ICCC International Computer Communications Conference ICCC International Carpathian Control Conference ICCC International Conference on Computer Communications , BSE See Bombay Stock Exchange. BSE See Boston Stock Exchange (BSE). : IMU Noun 1. IMU - a terrorist group of Islamic militants formed in 1996; opposes Uzbekistan's secular regime and wants to establish an Islamic state in central Asia; is a conduit for drugs from Afghanistan to central Asian countries ) today announced a license agreement on CryptoGAM cryptogam, in botany, term used to denote a plant that produces spores, as in algae, fungi, mosses, and ferns, but not seeds. The term cryptogam, from the Greek kryptos, meaning "hidden," and gamos, with Center for Special Immunology Inc. ("CSI") of Fort Lauderdale, Fla. CryptoGAM is ImmuCell's hyperimmune hyperimmune /hy·per·im·mune/ (hi?per-i-mun´) possessing very large quantities of specific antibodies in the serum. hyperimmune possessing very large quantities of specific antibodies in the serum. bovine immunoglobulin preparation being tested to treat and/or prevent cryptosporidiosis Cryptosporidiosis Definition Cryptosporidiosis refers to infection by the sporeforming protozoan known as Cryptosporidia. Protozoa are a group of parasites that infect the human intestine, and include the better known Giardia. in AIDS patients. Infection with Cryptosporidium parvum causes severe, chronic diarrhea in immunocompromised immunocompromised /im·mu·no·com·pro·mised/ (-kom´pro-mizd) having the immune response attenuated by administration of immunosuppressive drugs, by irradiation, by malnutrition, or by certain disease processes (e.g., cancer). individuals. In the United States, the company estimates that C. parvum infections occur in 5 percent to 15 percent of AIDS patients; associated mortality can be as high as 60 percent in this population. There are currently no effective vaccines or chemotherapeutic agents that can be used to control or eliminate the disease. ImmuCell will manufacture the clinical trial materials and continue to serve as IND sponsor; CSI has agreed to conduct ongoing clinical trials at its own expense in return for a royalty on future sales of the product. ImmuCell owns worldwide manufacturing and marketing rights to the product. CryptoGAM has been tested in four Phase I/II clinical trials involving 64 AIDS patients with cryptosporidiosis since receiving its IND and orphan drug designation in 1991. The trials have consistently demonstrated statistically significant microbiological benefit in the treatment groups but did not achieve the primary endpoint of reducing diarrhea. These trials have helped ImmuCell scientists improve their understanding of the disease and have guided their efforts to improve drug formulation and delivery. The most recent study under way is a blinded, placebo controlled prophylactic challenge/protection study being conducted with healthy volunteers in collaboration with The University of Texas at Houston. CSI operates a network of primary care clinics throughout the United States that specializes in providing medical services to 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. positive individuals and AIDS patients. The collaboration with CSI will give ImmuCell improved access to sub-groups of AIDS patients most likely to respond to therapy. Identification of these sub-groups has been a major benefit of ImmuCell's earlier clinical testing experience. In a related note, the company announced that it has seen encouraging results in the development of a method to detect the presence of C. parvum in public water supplies. In addition to being a life-threatening problem in AIDS patients, C. parvum has caused numerous disease outbreaks throughout the United States. The most notable to date was the massive outbreak in Milwaukee in early 1993 affecting over 400,000 individuals associated with municipal drinking water. ImmuCell has developed the method in collaboration with Membrex Inc. of Fairfield, N.J. The product is expected to enter beta testing to evaluate its performance under actual field conditions in the first half of 1996. Beta sites will include several large municipal water labs in the United States and Europe. ImmuCell Corp. is a public biotechnology company that primarily develops, manufactures and markets milk-derived passive antibody products to prevent gastrointestinal diseases in both humans and animals. CONTACT: ImmuCell Corp. Michael F. Brigham, 207/878-2770 ext. 106 |
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