AIDS TRIALS START COMPANY TESTS NEW INHIBITOR.Byline: Evan Pondel Staff Writer WOODLAND HILLS - Advanced Biotherapy biotherapy /bio·ther·a·py/ (-ther´ah-pe) biological therapy. bi·o·ther·a·py n. Treatment of disease with biologicals, such as vaccines. Inc. executives said Monday that the company has initiated clinical trials to treat AIDS patients who have not responded to more traditional therapies. The FDA-approved study will focus on 10 patients who no longer benefit from a widely administered cocktail of medications. The Woodland Hills- based company has tapped researchers at Georgetown University to study the effects of an inhibitor that essentially blocks proteins released by the body's 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. . Though these proteins can help the immune system, they are also potentially dangerous in patients with autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . ``This study is significant for us. It is the company's first clinical trial since the mid-1980s. And we are quite confident we will see a clinical effect,'' said Edmond Buccellato, Advanced Biotherapy's chief executive officer. AIDS research has recently garnered more attention, with many researchers focusing on inhibitors that can effectively treat myriad autoimmune diseases. Advanced Biotherapy is working with a protein called Tumor Necrosis Factor tumor necrosis factor n. Abbr. TNF A protein that is produced in the presence of an endotoxin, especially by monocytes and macrophages, is able to attack and destroy tumor cells, and exacerbates chronic inflammatory diseases. , which is often overproduced in patients that have chronic immune diseases. Dr. Joseph A. Bellanti, a professor of pediatrics and microbiology-immunology at Georgetown, said the study is intended to test the safety and possibly show that a TNF inhibitor can help restore normal immune system function in AIDS patients with advanced stages of the disorder. ``It's fairly easy to inhibit. But it's hard to inhibit both the good and the bad,'' Bellanti said. A cellular relationship called the cytokine Cytokine Any of a group of soluble proteins that are released by a cell to send messages which are delivered to the same cell (autocrine), an adjacent cell (paracrine), or a distant cell (endocrine). network is responsible for helping the immune system respond to viruses, bacteria, fungi and tumors. But 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. disrupts the process, causing the immune system to self-implode. Advanced Biotherapy is attempting to restore the network, theoretically improving a patient's ability to fight the AIDS virus. The Food and Drug Administration's approval of the study is also a boon for Advanced Biotherapy's business prospects. Commencing such a study can provide credibility for budding biotechnology companies that are usually in search of more venture capital or potential suitors. Buccellato, who is a certified public accountant Certified Public Accountant (CPA) An accountant who has met certain standards, including experience, age, and licensing, and passed exams in a particular state. , gained control of Advanced Biotherapy in 1996. The company was languishing lan·guish intr.v. lan·guished, lan·guish·ing, lan·guish·es 1. To be or become weak or feeble; lose strength or vigor. 2. at the time after a spate of poor management decisions and fruitless research. Today the company has about four employees and outsources most of its scientific research. ``When I took over the company, I had to rebuild it completely, and that takes some time,'' Buccellato said. Shares of Advanced Biotherapy have traded between 15 cents and 45 cents for about a year. The company rose 5 cents, or 12.8 percent, to close at 44 cents Monday on the OTC Bulletin Board OTC Bulletin Board An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system. . Buccellato said the company is poised to focus on several other research areas including multiple sclerosis, rheumatoid arthritis, corneal transplant rejection and certain autoimmune skin conditions. Evan Pondel, (818) 713-3662 evan.pondel(at)dailynews.com |
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