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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K/A
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest reported) July 14, 2004
Advanced Biotherapy, Inc.
(Exact name of registrant as specified in its chapter)
Delaware 0-26323 51-0402415
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
6355 Topanga Canyon Boulevard, Suite 510 91367
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Woodland Hills, California (Zip Code)
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(Address of principal executive offices)
Registrant's telephone number, including area code (818) 883-6716
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This Form 8-K/A amends Form 8-K filed on August 4, 2004. The purpose of this Amendment to Form 8-K is to correct the description and listing of Exhibit 10.13 to reflect that the Exhibit contains a redacted portion which is covered by an application for confidential treatment previously filed with the Securities & Exchange Commission.
Item 5. OTHER EVENTS.
The registrant published a press release on July 30, 2003 which reported that Advanced Biotherapy, Inc. has entered into an agreement to conduct joint clinical investigations with the Russian Federation Ministry of Health/State Institute of Transplantation and Artificial Organs.
Item 7. FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits.
Designation Description of Exhibit
10.13 Agreement for Joint Clinical Investigations between
the State Institute of Transplantation and Artificial Organs
of the Ministry of Health of the Russian Federation and
Advanced Biotherapy, Inc.; Subject to Redaction and
Application for Confidential Treatment Pursuant to
Rule 24b-2.
99.1 Press Release, dated July 30, 2003
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ADVANCED BIOTHERAPY, INC.
(Registrant)
Date: July 14, 2004 By: /s/ Edmond Buccellato
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Edmond Buccellato, President and CEO
INDEX TO EXHIBITS
Exhibit Description
10.13 Agreement for Joint Clinical Investigations between
the State Institute of Transplantation and Artificial Organs
of the Ministry of Health of the Russian Federation and
Advanced Biotherapy, Inc.; Subject to Redaction and
Application for Confidential Treatment Pursuant to
Rule 24b-2.
99.1 Text of Press Release, dated July 30, 2003
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Exhibit 10.13
SUBJECT TO REDACTION
AND
APPLICATION FOR CONFIDENTIAL TREATMENT
PURSUANT TO RULE 24B-2
AGREEMENT FOR JOINT CLINICAL INVESTIGATIONS
Both sides note that the first treatment of autoimmune diseases by removal of interferons (cytokines) was proposed in 1974 by Professor S.V. Skurkovich (Nature, 1974;247:551-2). He also proposed to remove TNF-(alpha) in various autoimmune conditions, including AIDS (J IFN & Cytokine Res 1989;9:S2 and other publications and patents). The use of anticytokines in autoimmune conditions has received wide experimental and clinical confirmation in various laboratories of the world. As is known, organ transplant rejection is also connected with autoimmune mechanisms. In joint investigations positive results were obtained with the use of antibodies to interferon-(gamma) in corneal transplants (Treatment of corneal transplant rejection in humans with anti-interferon-(gamma) antibodies. Am J Opthalmol 2002;133:829-30).
Based on this, the State Institute of Transplantation and Artificial Organs of the Ministry of Health of the Russian Federation ("Institute" herein) in the person of the Academician Russian Medical and Professor Valery Ivanovich Shumakov and Advanced Biotherapy, Inc. (ABI- USA) in the person of Professor S.V. Skurkovich, vice-president of ABI, agree to conduct joint clinical investigations on the reduction or prevention of organ transplant rejection by anticytokine therapy. In our joint investigation mainly anti-interferon-(gamma) antibodies will be used after transplantation of the heart, lung, liver, or pancreatic beta-islet cells.
Treatment of other conditions besides transplantation is possible.
ABI will supply the Institute with antibodies to interferon g and antibodies to TNIF-(alpha) and laboratory reagents (immunological) monitoring in accordance with a protocol for anticyotkine therapy.
[REDACTED - Confidential Portion Omitted and Filed Separately with the Securities and Exchange Commission]
Publications of the results of the clinical trials will be done jointly. ABI has the right to use the results of the trials as it wishes. The first publications of the treatment of each condition will be in English and the first author will be a representation of ABI. Later, if any Russian language reports are published, the first authors will be members of the Institute.
If the Institute wishes to send a representative to a conference outside of Russia to present the results of the clinical testing, ABI will pay expenses (registration, travel and hotel) for one attendee per conference.
This agreement is made and signed in English and Russian languages and has the same validity.
/s/Simon Skurkovich /s/Valery Ivanovich Shumakov
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on behalf of on behalf of
Advanced Biotherapy, Inc. the State Institute of Transplantation and
Artificial Organs of the Ministry of Health
of the Russian Federation
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EXHIBIT 99.1
PRESS RELEASE Source: Advanced Biotherapy, Inc.
ADVANCED BIOTHERAPY INC. LAUNCHES PROGRAM TO STUDY ANTIBODY THERAPY IN TREATING
ORGAN TRANSPLANT REJECTION Wednesday July 30, 8:43 pm ET
ANNOUNCES JOINT CLINICAL INVESTIGATION AGREEMENT WITH RUSSIA'S LEADING TRANSPLANT CENTER
LOS ANGELES--(BUSINESS WIRE)--July 30, 2003-- Advanced Biotherapy Inc. (OTCBB:ADVB - News) -- a developer of new antibody therapies for treating severe and widespread autoimmune diseases -- today announced that it has entered into an agreement to conduct joint clinical investigations with the Russian Federation Ministry of Health/State Institute of Transplantation and Artificial Organs. Under the agreement, the Institute will conduct human studies on select organ transplant patients using Advanced Biotherapy's investigational antibody therapies. The objective of the joint investigation is to evaluate the Company's antibody therapies in preventing or halting organ transplant rejection.
Advanced Biotherapy's antibody therapies are based on a pioneering theory first published nearly three decades ago in the journal Nature 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 of certain immunomodulator substances to treat autoimmune diseases has achieved wide support in the international scientific community and has achieved commercial viability.
Autoimmune diseases are the result of an inappropriate immune response in which the body's immune system attacks healthy cells and organs. Certain chemicals called cytokines are hyperproduced, which brings about the autoimmune condition. One of Advanced Biotherapy's antibody therapies is designed to remove or neutralize these excessive cytokines known as gamma interferon and tumor necrosis factor-alpha, induced by gamma interferon.
Removal of these agents is associated with therapeutic effects, and could possibly be a universal treatment for certain types of autoimmune diseases. Advanced Biotherapy has already achieved encouraging results in clinical trials in rheumatoid arthritis, multiple sclerosis, various autoimmune skin diseases (psoriasis, alopecia areata, vitiligo, pemphigus, epidermolysis bullosa), and others.
"As a result of our strong patent position and the very promising investigational clinical study results we have already achieved in a number of autoimmune conditions at various well-respected research institutes in Moscow, Russia, as more specifically reported by the Company in its recent Securities and Exchange reports, we have accepted an invitation from Russia's leading transplant institute to conduct human studies," says Ed Buccellato, Advanced Biotherapy's CEO. "The State Institute of Transplantation and Artificial Organs is Russia's largest transplant center. It conducts more than 100 kidney transplants alone each year, in addition to heart, liver and lung transplants. It is now known that the body reacts to organ and cell transplantation in much the same way it reacts to an autoimmune disease. The Company maintains that treatment for organ transplant rejection can be similar to treatment for autoimmune diseases."
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 reported, antibodies to interferon-gamma halted corneal transplant rejection in all patients that were treated.
The Company also recently performed investigational clinical testing at the Research Institute of Pediatric Hematology of Russia of its anti-interferon gamma antibody on several children with type I diabetes, an autoimmune disease. Results of this study, allowing all patients to lower their daily insulin dose, are scheduled to be presented in Berlin at the "8th International Workshop on Autoantibodies and Autoimmunity" in September.
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Mr. Buccellato further commented, "In the Institute's clinical investigations, the Company's first project will be to administer our investigational antibodies to gamma interferon and to tumor necrosis factor-alpha after transplant of insulin-producing pancreatic beta cells in type I diabetic patients."
Mr. Buccellato added, "We also find it quite encouraging that a number of noted U.S.-based biotechnology companies have, and continue, to conduct investigational clinical trials in Russia."
About Advanced Biotherapy
Advanced Biotherapy, Inc. is pioneering the development of new antibody therapies for treating severe and widespread autoimmune diseases. Its investigational therapies attack autoimmune diseases at their source, neutralizing biologic imbalances that impair immune system function. Core technology is protected under U.S. 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. www.advancedbiotherapy.com
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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Contact:
Advanced Biotherapy, Inc.
Amy Buccellato, 818-883-6716
www.advancedbiotherapy.com
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End of Filing
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