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MIRAMAR, Fla. -- Sunol Molecular Corporation, in collaboration with the Division of Microbiology and Infectious Diseases (DMID) at the National Institutes of Health, and the Uniformed Services University of the Health Sciences (USUHS), announced the start of a Phase 1 clinical trial. This trial will evaluate the safety of an antibody for treatment of people infected by EHEC (Enterohemorrhagic E. coli), the notorious pathogen often acquired by eating contaminated foods.
According to the Centers for Disease Control and Prevention (CDC) approximately 73,000 cases of infection with O157:H7, the most common form of EHEC, are thought to occur each year in the United States. About 10 to 15 percent of infected children are at risk of developing severe symptoms including neurological damage and Hemolytic uremic syndrome (HUS), which can result in kidney failure and death. HUS is the leading cause of kidney failure in children and there are no currently approved agents for preventing HUS.
The Phase 1 trial is being conducted by the Center for Vaccine Development at the University of Maryland in Baltimore. Initially, healthy volunteers will be given an antibody to evaluate its safety in humans. The antibody neutralizes one of the two Shiga toxins released by the pathogenic E. coli strains during infection. A second antibody to neutralize the second Shiga toxin is expected to enter a Phase 1 trial later this year. These two antibodies will be evaluated together in a subsequent Phase 2 trial to assess their effectiveness in preventing HUS in EHEC-infected patients.
Sunol's chairman and CEO, Dr. Hing Wong, commented: "We're delighted to be able to employ Sunol's proprietary recombinant monoclonal antibody technology platform to develop another promising therapeutic candidate. Our collaboration with the DMID and USUHS to develop these antibodies, together with the DMID sponsorship of the Phase 1 clinical trial, is a mutually beneficial partnership designed to expedite the availability of a novel therapy for this serious public health issue and potential bioterrorism agent."
Sunol Molecular Corp. began operations in 1996 and is a privately held company engaged in the discovery and development of novel human therapeutics to treat cardiovascular disease, cancer, inflammatory disorders and infectious diseases.
Source: Sunol Molecular Corporation