NIH awards over $15M for Tulane University's collaborative effort to combat VHF

Corgenix Medical Corporation (OTC Bulletin Board: CONX), a worldwide developer and marketer of diagnostic test kits, and Tulane University, today announced a major extension of the collaborative effort to combat viral hemorrhagic fever (VHF), an effort that will generate an additional $800,000 in contract revenue for Corgenix over the life of the contract.

The National Institutes of Health (NIH) has awarded a five-year contract totaling $15,224,927 to Tulane University for the expanded study. Collaborating with Corgenix and Tulane in this contract are The Scripps Research Institute, the University of California at San Diego, Boston University, the Broad Institute, Harvard University, Autoimmune Technologies, LLC, Vybion, Inc. and various partners in West Africa.

"This study will result in a fundamental understanding of the mechanisms of antibody detection and antibody mediated neutralization of Lassa virus," said James Robinson, M.D., Professor of Pediatrics at the Tulane University School of Medicine and Principle Investigator of the program. "This research has significant implications for the next generation of antibody based therapeutics against viral hemorrhagic fevers."

Dr. Robinson stated further, "We have assembled a very strong and diverse group of institutions to collaborate on this project. Our goal is to elucidate the role of humoral immunity in protection or pathogenesis of Lassa fever. We will derive a diverse set of monoclonal antibodies from patients infected with Lassa virus, which causes Lassa fever. These human antibodies will be evaluated for their ability to protect from the severe consequences of the disease, and could play a role in treatment or prevention of this illness in areas of West Africa where Lassa fever is common."

This is the third major award given to Tulane for Lassa virus research. Under the original two grants awarded in 2005 and 2009, the group developed and patented new recombinant proteins for Lassa virus and developed several viral detection products that have been deployed in Africa for clinical testing where most VHFs are endemic.

"We are extremely pleased to be part of this expanded collaboration and to have received the NIH contract," said Douglass Simpson, Corgenix President and CEO. "Building on the previous two grants for development of state-of-the-art diagnostic tests on multiple delivery platforms, this new contract will enable Tulane and the other collaborators to probe deeper into the mechanisms of the virus, which can ultimately lead to prevention of the disease."

"This important research will save lives and help prevent this deadly disease. Boston University School of Medicine is pleased to be collaborating with such an esteemed group of researchers," said Thomas Geisbert, Ph.D., Associate Director of the National Emerging Infectious Diseases Laboratories Institute at Boston University.

Lassa fever, a serious viral disease spread by contact with infected rodents, is estimated to infect hundreds of thousands of people per year across the countries of Sierra Leone, Guinea, Liberia and Nigeria in West Africa, with approximately five thousand deaths annually. In some areas of Sierra Leone, up to 16 percent of people admitted to hospitals have Lassa fever. Lassa fever is also associated with occasional epidemics, during which the case-fatality rate can reach 50 percent.

Because of the high case fatality rate, the ability to spread easily by human-to-human contact, and the potential for aerosol release, Lassa is classified as a BSL-4 (bio safety level 4 agent) and is included on the NIAID Category A select agents list of potential bio-terrorism threats.

"Vybion is delighted to use ProCode to define epitopes on viral antigens that may not be triggered by the immune system and help to define critical regions of these viruses for function, neutralization and potential vaccine development," said Vybion CEO Lee Henderson, Ph.D. These epitopes will be structurally mapped by Erica Ollmann Saphire, Ph.D., of The Scripps Research Institute.

Robert Garry, Ph.D., Professor of Microbiology and Immunology at the Tulane University School of Medicine, added, "We have been very pleased with the results of our development effort over the past five years. The diagnostic products have shown to be remarkably effective in clinical settings in Africa and will have a meaningful impact on the healthcare in that part of the world, but will also fill a critical gap in bioterrorism defense. Now under the new NIH award, we will move to the next level allowing us to better treat the disease, or ultimately prevent it altogether."

Dr. Garry stated that the group intends to expand this program to address other important infectious agents—such as Ebola, Marburg and other hemorrhagic fever viruses—that kill hundreds of thousands of people and are of concern to the public health and bioterrorism preparedness communities.