Collaboration Advances Potential Therapy For Autoimmune Diseases

[Guest guest]

Date:   Posted 6/4/2002

Collaboration Advances Potential Therapy For Autoimmune Diseases

RICHLAND, Wash. -- The Department of Energy's Pacific Northwest National

Laboratory has launched a collaboration with two U.S. companies and Russian

scientists to develop a more effective treatment for autoimmune diseases,

such as rheumatoid arthritis and multiple sclerosis, which afflict nearly 50

million Americans. The collaboration represents the latest commercial

venture between a former Russian weapons facility, a DOE national laboratory

and U.S. industry under DOE's Initiatives for Proliferation Prevention

program (IPP).

Through a ative Research and Development Agreement, Advanced

Biotherapy Inc. of Woodland Hills, Calif., and New Horizon Diagnostics Inc.

of Columbia, Md., will hold nonexclusive licenses to inventions created by

scientists at the Institute of Immunological Engineering of Moscow or by

PNNL researchers through this program.

The Russian scientists have created unique humanized antibodies to gamma

interferon, a protein that when overproduced triggers and exacerbates

various autoimmune conditions. This work is a major step toward creating a

much-improved treatment for certain autoimmune diseases. Until recently,

most treatments employed antibodies derived from mice, which were effective

but could be used only one or two times before the human body rejected them.

Antibodies are proteins that bind to and disable foreign proteins, called

antigens. With fully humanized antibodies, the human body potentially could

accept them over longer periods of time, thus providing for long-term

treatment.

The Russian research, coupled with a treatment method developed by Advanced

Biotherapy, appears promising. During the past year, PNNL scientists have

worked closely with the Russians to verify research results, monitor

progress and identify and secure a viable commercial partner. PNNL is the

technical lead for most biological and chemical-related projects conducted

throughout several national laboratories for IPP.

" This agreement will allow us to leverage the incredible expertise found in

the Russian institutions and in these companies, " said Weller, PNNL

principal investigator. " Our main objective is to make it possible for these

organizations to develop a therapy that will remove the symptoms of these

painful diseases so people can live better lives. "

Of the 50 million Americans suffering from autoimmune diseases, nearly 75

percent of those are women, according to the American Autoimmune-Related

Diseases Association. Arthritis, an autoimmune disease, is the leading cause

of disability in the United States and will impact nearly 60 million

Americans by 2020, according to the Centers for Disease Control. Other

autoimmune diseases include lupus, insulin-dependent diabetes and arthritis

of the spine. These diseases erupt when the immune system mistakenly attacks

itself rather than protects itself. While the root causes of these attacks

largely are unknown to scientists, results can be organ-specific disorders,

such as insulin-dependent diabetes that affects the pancreas, or disorders

that impact the entire body, such as rheumatoid arthritis, in which joints

swell.

Advanced Biotherapy has designed and received a method of use patent for the

exclusive use of any form of antibody - including monoclonal, humanized and

fully human - to gamma interferon to treat multiple sclerosis, rheumatoid

arthritis, juvenile rheumatoid arthritis, psoriatic arthritis and ankylosing

Spondylitis (inflammation and stiffening of the spinal cord). The company

already has conducted limited clinical trials of antibodies to gamma

interferon for rheumatoid arthritis and multiple sclerosis.

Through this collaboration, and under its patent protection, Advanced

Biotherapy will evaluate the efficacy of the humanized antibodies when

combined with the company's own treatment method. It also will continue

clinical trials in Russia.

" If we can control the production of this protein, we then may be able to

control the disease, " said Edmond Buccellato, CEO of Advanced Biotherapy.

" We believe that blocking the action of this cytokine could be the basis for

a universal treatment for a host of autoimmune diseases. "

New Horizon Diagnostics will develop assay systems to measure and monitor

the levels of antibodies to determine effectiveness and conditions of

treatment.

DOE's IPP (www.nn.doe.gov/ipp.shtml) program funded this research with the

goal of creating non-defense jobs for former Soviet weapons scientists by

linking them with U.S. companies interested in commercializing their

non-weapons technologies. IPP projects have engaged more than 500 former

weapons scientists in pursuing commercial applications.

If this antibody proves effective, the companies could patent the inventions

in the United States, while the Russian scientists would control rights to

produce and market the technology in the former Soviet Union. Advanced

Biotherapy and New Horizon Diagnostics will match DOE's funding of $650,000

through combined in-kind donations.

Business inquiries on this or other PNNL technologies should be directed to

1-888-375-PNNL or e-mail: inquiry@.... Advanced Biotherapy (OTCBB:ADVB)

holds a patent on its treatment method for five diseases, which include four

types of arthritis and multiple sclerosis. The Institute of Immunological

Engineering was part of Bipreparat, the organization that once directed the

Soviet Union's germ warfare program and now is a state-owned drug company.

New Horizon Diagnostics develops technologies that enable the rapid

identification and treatment of infectious diseases and pathogens.

Pacific Northwest National Laboratory is a DOE research facility and

delivers breakthrough science and technology in the areas of environment,

energy, health, fundamental sciences and national security. Battelle, based

in Columbus, Ohio, has operated the laboratory for DOE since 1965.

http://www.pnl.gov/news/2002/02-15.htm