EluSys Begins Trials of Heteropolymer in Humans; First Use of HP System in Humans
PINE BROOK, N.J., Jan. 28 /PRNewswire/ -- EluSys Therapeutics, Inc. announced today that it has started human studies of its Heteropolymer (``HP'') System, which marks the first time the technology will be evaluated in human beings.
The trial will evaluate the safety of a lupus Heteropolymer, ETI-104, in normal, healthy human volunteers. Investigators will enroll the volunteers in a randomized trial that compares two doses of the HP drug to placebo. EluSys expects to finish this safety trial by the beginning of March and, assuming the HP drug is shown to be safe in normal volunteers, will immediately initiate a second safety study in people with systemic lupus erythematosus (SLE).
``We are very proud to have reached this important milestone with the heteropolymer technology in our brief corporate history,'' said Stephen Sudovar, president and CEO of EluSys. ``Our extensive preclinical data show an excellent safety profile and we look forward to validating the safety of the Heteropolymer System in man.''
Lupus is an autoimmune disease of unknown origin, involving the production of autoantibodies -- antibodies targeted against normal tissue components in the body -- that cause inflammation and damage to a variety of organs. There is currently no cure for this disease that afflicts approximately 530,000 Americans, but therapies are available that improve the symptoms of lupus in some patients.
``People with lupus suffer tremendously and need more treatment options,'' noted Linda Nardone, PhD, vice president of clinical and regulatory affairs for EluSys. ``One of the primary concerns with lupus is kidney damage or kidney failure. We hope that the HP System can reduce the frequency and severity of the kidney flares that lead to damage.''
The EluSys study is a Phase I, or safety, trial to verify that a drug is safe to use in humans. These studies are required by the U.S. Food and Drug Administration (FDA) as part of a three-phase process (Phase II trials demonstrate that a drug is effective against the target disease or organism; Phase III studies compare the effectiveness of the trial drug in a larger group of patients against the standard of care for the disease) that must be completed successfully before a company can ask the FDA to review a drug.
``The lupus safety studies are only the beginning of our evaluation of the heteropolymer technology in humans for a broad range of diseases,'' commented George Spitalny, PhD, vice president of research and development for EluSys. ``The HP System has potential application against a variety of human infections including hepatitis, Staphylococcus, Pseudomonas and E. coli. This is in addition to the strong promise the HP System shows against agents of biological warfare, such as anthrax and smallpox.''
The Heteropolymer System: ``Biological Double-Sided Tape''
EluSys' Heteropolymer System is a monoclonal antibody-based technology designed to enable the body to use its own red blood cells to efficiently remove and destroy a wide variety of blood-borne pathogens, toxins and autoantibodies. The HP System uses a proprietary bi-specific monoclonal antibody (the Heteropolymer) that binds both to the target pathogen and to red blood cells like a piece of biological double-sided tape. The red blood cells carry the Heteropolymer-pathogen complex to the liver, where it is destroyed. The HP System can be engineered to be active against anything that circulates in the bloodstream.
The HP System is modified slightly for autoimmune diseases: Instead of two monoclonal antibodies that are chemically attached, one monoclonal antibody is linked to an antigen that stimulates the immune system to produce the target autoantibody. The Antigen-Heteropolymer (AHP) binds the autoantibody to red blood cells for removal and destruction in the liver. Preclinical studies have shown that AHPs can remove from the blood antibodies similar to those produced in people with SLE. The AHP agent under study, ETI-104, is a monoclonal antibody to a receptor on the red blood cell cross-linked to double-stranded DNA.
Experiments demonstrate that the HP System can clear even substantial levels of a variety of pathogens and autoantibodies from the bloodstream within an hour. Other experiments have shown that EluSys' Heteropolymers may prevent pathogens from ever reaching appreciable concentrations in the blood when injected before exposure.
EluSys Therapeutics, Inc. is a privately held biopharmaceutical company focused on developing treatments for a variety of blood-borne diseases. EluSys' patented monoclonal antibody-based technology, the Heteropolymer System, may offer a significant advance in the management and treatment of blood-borne viruses, bacteria, toxins and autoantibodies by enhancing the effectiveness of the body's own natural defense mechanisms to remove such pathogens from the blood and destroy them. Founded in 1998, EluSys is headquartered in Pine Brook, NJ. Additional information about EluSys, the HP technology and senior management can be found at www.EluSys.com. |
