Advanced Biotherapy Inc. Announces Intent to Prepare for Clinical Trials for Use of Antibodies to Gamma Interferon to Treat Corneal Transplant Rejection.Business Editors & Health/Medical Writers LOS ANGELES--(BUSINESS WIRE)--Dec. 9, 2002 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. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :ADVB ADVB Associação dos Dirigentes de Vendas e Marketing do Brasil ) reported today that it has met with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) and discussed the pathway and additional efforts needed to submit an Investigational New Drug Application (IND) to conduct Phase I clinical trials to treat corneal transplant corneal transplant Ophthalmology The replacement of a damaged cornea with a cadaveric–healthy donor cornea; CTs are indicated in severe corneal injury or for corneal ulcers with residual scarring rejection with antibodies to gamma interferon. As previously reported, the company received a "Notice of Allowance" from the United States Patent and Trademark Office The United States Patent and Trademark Office (PTO or USPTO) is an agency in the United States Department of Commerce that provides patent protection to inventors and businesses for their inventions, and trademark registration for product and intellectual property (USPTO USPTO abbr. United States Patent and Trademark Office ) for a utility patent for the use of any form of antibody to gamma interferon to treat corneal transplant rejection. The patent is expected to be issued within 120 days, according to President and Chief Executive Officer, Edmond F. Buccellato. The USPTO issues a Notice of Allowance when a company has completed the application and review process for a U.S. patent and has satisfied all of the legal criteria for patentability of the invention. Buccellato stated, "The filing of our first IND application since the mid 1980s, when the Company conducted Phase I clinical trials to treat AIDS patients at Georgetown University with antibodies to alpha interferon, will be another important milestone for the Company. The Company is now in the process of meeting specific requirements of the FDA before it submits this application. Our business strategy has been to conduct pre-clinical human studies abroad to establish proof-of-concept; to apply for, and secure patents; and now to proceed with meeting all regulatory requirements for conducting clinical trials in the U.S." Advanced Biotherapy is developing new therapeutic strategies for the treatment of severe 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 . Drugs that may be developed under the company's patents neutralize immunomodulators called cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. , which have been linked to diseases such as rheumatoid arthritis, multiple sclerosis, psoriasis, AIDS and other autoimmune diseases. Statements made in this news release, other than statements of historical fact, are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the anticipated results or other expectations expressed in our forward-looking statements. The risks and uncertainties which may affect the development, operations and results of our business include, but are not limited to the following: risks associated with clinical trials, the uncertainties of research and product development programs, the uncertainties of the regulatory approval process, the risks of competitive products, the risks of our current capital resources, the uncertainties as to the availability of future capital and our future capital requirements, and the risks associated with the extent and breadth of the Company's patent portfolio. The foregoing discussion of the effect of the patents issued and pending involves risks and uncertainties, including but not limited to the risks that third parties may be successful in challenging such patents; or that granted claims may be held invalid or interpreted differently by a court of law; or that new technologies will be developed that are superior in treating the diseases targeted by Advanced Biotherapy, Inc. Readers are cautioned not to place reliance on these forward-looking statements, which speak only as of the date the statements were made. See the Company's public filings with the Securities and Exchange Commission for further information about risks and uncertainties that may affect the Company and the results or expectations expressed in our forward-looking statements, including the section captioned "Factors That May Affect The Company" contained in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2001. |
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