Through a Cooperative 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 Richard 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: firstname.lastname@example.org. 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.