CYTEL FILES IND ON THERAPEUTIC VACCINE FOR CHRONIC HIV INFECTION.SAN DIEGO--(BUSINESS WIRE)--Dec. 19, 1996--Cytel Corporation (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 :CYTL) announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for its 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. therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. , known as CY2301. The IND filing represents a significant milestone under a Strategic Programs for Innovative Research on AIDS Treatment (SPIRAT) grant awarded by the National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ) in 1995. The $3.3 million grant funds a multi-project program, including human clinical trials to be conducted at Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world . Cytel is aiming to develop an immunotherapeutic vaccine to control or eradicate chronic retroviral infection through the induction of virus-specific killer T-cells (cytotoxic T lymphocytes). Cytel's HIV vaccine HIV vaccine AIDS As of mid-2005, there is no viable anti-HIV vaccine. See AIDS. utilizes Cytel's proprietary Theradigm(TM) technology and is designed to stimulate a virus-specific cellular immune response cellular immune response n. See cell-mediated immune response. against the viral antigen. Cytel's lead drug candidate in the Theradigm program is Theradigm-HBV, which is aimed at treating chronic hepatitis B infection. In Phase I and II clinical trials to date, Theradigm-HBV has safely stimulated a virus-specific cellular immune response (cytotoxic T lymphocytes, or killer T cells) in healthy volunteers and patients infected with hepatitis B. Cytel recently announced plans to initiate clinical studies of Theradigm-HBV in combination with an anti-viral agent in early 1997. Upon approval of the IND, Cytel will initiate a Phase I/II clinical trial designed to test safety of CY2301 and its ability to induce a CTL See control key. 1. CTL - Checkout Test language. 2. CTL - Compiler Target Language. 3. CTL - Computational Tree Logic response in HIV-infected patients. The trial will be conducted by Drs. Deborah Cotton, Bruce Walker and Spyros Kalams at Massachusetts General Hospital and is anticipated to begin in the first quarter of 1997. Cytel Corporation is a leader in the discovery, design and development of immunotherapeutics, a class of drugs which the company believes will be more selective and have fewer side effects than drugs currently on the market. Cytel's core technology platforms consist of the Immune Stimulation Program under which the company is developing therapeutic vaccines for infectious diseases and cancers, the Immune Suppression Program which is based on anti-inflammatory cell adhesion inhibitors, and Glycotechnology -- its proprietary SNC SNC St Norbert College (De Pere, Wisconsin) SNC Sistema Nervioso Central SNC Société en Nom Collectif (French: Partnership) SNC Système Nerveux Central (French: central nervous system) Technology enabling the manufacture of large quantities of complex carbohydrates at commercially viable prices. Actual results may differ materially from the above forward-looking statements due to a number of important factors, including but not limited to the risks associated with the timing and cost of conducting human clinical trials, the regulatory approval process and the possibility that testing may reveal undesirable and unintended side effects or other characteristics that may prevent or limit the commercial use of proposed products. These factors are more fully discussed in Cytel's most recent Form 10-K and Form 10Qs. CONTACT: Cytel Corp., San Diego Karin Eastham Vice President and Chief Financial Officer 619/552-3000 |
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