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Advanced Biotherapy, Inc. Discloses Patent Pending for Use of Antibodies to Treat Solid Organ and Cell Transplant Rejection.


Business Editors/Health/Medical Writers

WOODLAND HILLS, Calif.--(BUSINESS WIRE)--Aug. 5, 2003

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 ) announced today that it has a patent application pending for the use of antibodies to gamma interferon (IFN-gamma) and tumor necrosis factor-alpha Tumor necrosis factor (TNF, cachexin or cachectin and formally known as tumor necrosis factor-alpha) is a cytokine involved in systemic inflammation and is a member of a group of cytokines that all stimulate the acute phase reaction.  (TNF-alpha) and both antibodies combined for the treatment of solid organ and cell transplant rejection transplant rejection Graft rejection, organ rejection, tissue rejection Immunology The constellation of host immune responses evoked when an allograft tissue is transplanted into a recipient; rejection phenomena may be minimized by optimal matching of MHC antigens . As previously reported, 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
) issued U.S. Patent No. 6,333,032 to the Company for the exclusive use of IFN-gamma antibodies -- including humanized and fully human, as well as other antibody types -- to treat Multiple Sclerosis, Rheumatoid Arthritis rheumatoid arthritis

Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course.
, Juvenile Rheumatoid Arthritis juvenile rheumatoid arthritis
n. Abbr. JRA
Chronic inflammatory arthritis that begins in childhood, characterized by swelling, tenderness, and pain in one or more joints and by lymph node and splenic enlargement.
, Psoriatic Arthritis Psoriatic Arthritis Definition

Psoriatic arthritis is a form of arthritic joint disease associated with the chronic skin scaling and fingernail changes seen in psoriasis.
 (a form of psoriasis) and Ankylosing Spondylitis Ankylosing Spondylitis Definition

Ankylosing spondylitis (AS) refers to inflammation of the joints in the spine. AS is also known as rheumatoid spondylitis or Marie-Strümpell disease (among other names).
, U.S. Patent No. 6,534,059 for the use of antibodies to IFN-gamma for treating 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.
 response in the eye (corneal transplant rejection), and U.S. patent No. 5,888,511 entitled "Treatment of autoimmune diseases, including AIDS."

Commenting on this announcement, Edmond Buccellato, the Company's 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. , stated, "There are approximately 82,000 people waiting for a solid organ transplant solid organ transplant Immunology A transplanted solid organ–eg, heart, liver, kidney, as contrasted to 'liquid' transplanted tissues–eg, BM, pancreatic islets. See Transplant, Transplantation.  in the United States at any one time. Of these, about 56,000 are waiting for a kidney transplant, about 1,500 are waiting for pancreatic beta cell transplant, about 17,000 are waiting for a liver transplant, and about 4,000 are waiting for a heart transplant. Many individuals with serious and life-threatening illnesses are also waiting for bone marrow transplants. Approximately 2,000 solid organ transplants are performed each month. The number of candidate recipients far outweighs the number of available organs. After the organ has been transplanted into the patient and the patient's immune system is suppressed to prevent rejection of the new organ, two common outcomes frequently result. The first is infection. If detected early, most infections can be treated with antibiotics or other standard therapies along with supportive treatment with few or no long term effects to the patient or transplanted organ. The second occurrence is rejection. Solid organ transplant rejection is currently prevented by matching the donor organ with the recipient and through immunosuppressive therapy after the transplant procedure is completed. After the donor organ has been matched and implanted, organ transplant recipients must take immunosuppressive medication for the rest of their lives. Initial doses of immunosuppressive medications are usually quite high, and are accompanied by varied and serious side effects. Over time, the doses of immunosuppressive medication can be lowered with an accompanying decrease in side effects and infection susceptibility. However, the generalized immunosuppressive medications currently in use are not without significant problems. In fact, the general immunosuppressants immunosuppressants,
n.pl the agents that lower or reduce immune response; useful in organ transplant surgery to prevent organ rejection. Corticosteroid hormones given in large amounts; cytotoxic drugs, including antimetabolites and alkylating agents;
 currently used suppress all immunological reactions to antigens, either those present on the transplanted organ or those encountered from infectious microbes, tumor cells, or other disease causing anomalies, and overwhelming infection remains the leading cause of death in transplant recipients."

Mr. Buccellato further commented, "In a previous joint clinical investigation conducted at the Research Institute of Eye Diseases of the Russian Academy of Medical Sciences, positive results were obtained with the use of Advanced Biotherapy's investigational antibodies in patients suffering from corneal transplant rejection ("Treatment of Corneal Transplant Rejection in Humans with Anti-Interferon-Gamma Antibodies," Am. J. Ophthalmology 2002; 133:829-30). As we reported, antibodies to interferon-gamma halted corneal transplant rejection in all thirteen patients that were treated. Accordingly, it is our view that administration of an effective amount of antibody that specifically binds to these 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.
 is useful in alleviating, treating, or eliminating the rejection of a solid organ or cell transplant."

About Advanced Biotherapy, Inc.

Advanced Biotherapy, Inc. is pioneering the development of new antibody therapies for treating severe and widespread autoimmune diseases based on a new understanding of the cause of these conditions. Its investigational therapies attack autoimmune diseases at their source, neutralizing biologic imbalances that impair immune system function. Core technology is protected under US patents and patents pending for the exclusive use of a class of antibodies to the protein known as gamma interferon and to tumor necrosis factor-alpha for treating a range of diseases. The company is headquartered in Woodland Hills, California.

Advanced Biotherapy's antibody therapies are based on a pioneering theory first published nearly three decades ago in the journal Nature and later in other scientific journals by Simon Skurkovich, M.D., Ph.D., D.Sc. - the Company's director of research and development. Since it was first proposed, the concept of neutralizing the body's overproduction o·ver·pro·duce  
tr.v. o·ver·pro·duced, o·ver·pro·duc·ing, o·ver·pro·duc·es
To produce in excess of need or demand.



o
 of certain immunomodulator substances to treat autoimmune diseases has achieved wide support in the international scientific community and has achieved commercial viability.

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 pending clinical investigations and 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, 2002.
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Publication:Business Wire
Geographic Code:1USA
Date:Aug 5, 2003
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