SRD Pharmaceuticals Acquires Drug Patents for New Treatment of AIDS; Will Apply to Utilize FDA's ``Fast Track'' System to Expedite Marketing Approval.Business Editors/Health/Medical Writers LOS ANGELES--(BUSINESS WIRE)--May 3, 2004 SRD SRD Suriname Dollar (ISO currency code) SRD Sustainable Resource Development (Alberta, Canada) SRD Short Range Devices (wireless networking) SRD System Reference Document Pharmaceuticals, Inc. today announced it has acquired 4 U.S. patents, 16 corresponding foreign patents and 4 additional patents pending from Nissin Foods, Ltd. of Japan. The acquisition includes the associated technologies and FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. filings related to an AIDS drug developed by Nissin's Molecular Biology molecular biology, scientific study of the molecular basis of life processes, including cellular respiration, excretion, and reproduction. The term molecular biology was coined in 1938 by Warren Weaver, then director of the natural sciences program at the Rockefeller Institute. Nissin spent 10 years and 17 million dollars to create this drug for the treatment of AIDS, based on "humanized" 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 (MAb) technology. The drug binds to the 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. virus and leads to the activation of a part 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. that disrupts the virus. SRD plans to conduct clinical trials through Phase II and will seek a partnership with a major pharmaceutical company. The company intends to acquire strong clinical safety and efficacy data that will enable it to obtain early product-marketing approval. SRD will apply to the FDA's "fast track" system, a program designed to expedite marketing approval of new drugs that combat life-threatening and debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction diseases such as AIDS and cancer. "SRD is thrilled to have acquired these patents from Nissin Foods," said Howard M. Rosenkrantz, Chairman of SRD Pharmaceuticals' Advisory Board and former President and COO of United States Surgical Corporation. "A lot of time, energy and money have gone into the creation of this innovative drug, and we will work to get it on the market as quickly as possible." "This new drug offers many benefits over current treatments," said Sami Hashim, M.D., Medical Advisor of SRD Pharmaceuticals and Professor Emeritus at Columbia University. "SRD's goal is to apply its technology to the development of the next generation of drugs for the treatment of AIDS and other diseases." The drug was tested in 1999 on HIV-infected individuals at Harvard Medical School's Beth Israel Deaconess Medical Center Both an international and regional referral center, Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts is a major teaching hospital of Harvard Medical School. It was formed out of the 1996 merger of Beth Israel Hospital (founded in 1916) and by Dr. Bruce Dezube, Associate Professor of Medicine and Principal Investigator. The results of the initial four-person study showed that the antibody was well tolerated, and no side effects Side effects Effects of a proposed project on other parts of the firm. were noted, even at the highest dose. The half-life of the antibody was 6.5 days, which indicates it may require only weekly administration. By comparison, the current approved regimens often require patients to take many pills on a daily basis, including anti-retroviral and other supportive medications. SRD's monoclonal drug also offers a potential solution to the problem of resistance in current medications. "AIDS and cancer are two of the greatest threats to the health of citizens globally and there is no doubt that we need to develop better ways to fight them," said David Horowitz, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of SRD Pharmaceuticals and a founder of Calypte BioMedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. . "The initial tests results of our drug offer promising results in fighting this disease with few side effects, and will hopefully represent the next step forward in the evolution of treatment for this disease." Humanized monoclonal antibodies (Mab) form the basis for a revolutionary class of powerful therapeutic drugs. Several of them have been approved and others are moving along the development track into clinical studies for the treatment of cancer and various other infectious and autoimmune diseases. Permission to begin Phase I clinical trials was granted under the stringent requirements of the FDA following the submission of an "investigational new drug" (IND) application. Howard Rosenkrantz, David Horowitz and Dr. Sami Hashim are leading SRD's experienced management team. Prior to his former role as President and COO of United States Surgical Corporation, Rosenkrantz served as Senior VP of Finance, CFO See Chief Financial Officer. , and was a trustee on the Committee for Economic Development. Dr. Hashim, who has contributed to over 200 publications in peer-reviewed journals, is also Professor Emeritus at Columbia University as well as Senior Attending Physician of the Department of Medicine and former Director of the Division of Metabolism and Nutrition at St. Luke's Roosevelt Hospital. Horowitz was a founder of Calypte BioMedical, a company whose AIDS urine test has already been approved by the FDA. About SRD Pharmaceuticals SRD is a pharmaceutical company engaged in the development of drugs for the treatment of HIV and other diseases. The company's "humanized" monoclonal antibody "Mab" technology is protected by 4 U.S. patents, 16 associated foreign patents and 4 patents pending. SRD has offices in Westport, Connecticut, and Los Angeles, California. |
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