CEL-SCI Gets Government Grant to Develop CEL-1000 Against Smallpox

VIENNA, Va. -- Cel-Sci Corporation has been awarded a Phase I SBIR (Small Business Innovation Research) grant from the National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), in the amount of $104,000 for the development of CEL-1000 as a potential therapeutic and prophylactic agent against vaccinia and smallpox infections as a single agent and as an adjuvant for vaccinia vaccines. Vaccinia is the virus used in the smallpox vaccine.

This work will be done in collaboration with the laboratory of Dr. James Talmadge, Professor, department of pathology and microbiology at the University of Nebraska Medical Center in Omaha and will involve animal viral challenge studies and an analysis of the immune responses thereto.

This new bioterrorism related grant follows a April 2003 $1.1 million grant that was awarded to develop CEL-1000 as a treatment for viral encephalitis, which includes West Nile Virus and three other viruses that the U.S. government has put into its listing as possible bio-terrorism agents. Also, in June 2003 CEL-SCI signed a Cooperative Agreement with the NIAID and the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) to test CEL-1000 against various bio-terrorism agents as well as other hard to treat diseases. In May 2003 CEL-SCI also received a grant to develop CEL-1000 against herpes simplex.

CEL-1000 is a peptide that activates innate (very early stage) and Th1 type (cellular) immune responses to induce broad-spectrum protection against infection in animal models. The innate immune system is generally accepted to be the first line of defense against infectious agents. CEL-1000 has been shown to protect against herpes simplex, malaria and cancer in animals.

At the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago earlier this month, researchers presented how protection was initiated by CEL-1000 against herpes in animals. Very soon after, and for several days following CEL-1000 treatment, the cytokine IL-12 is released and found in the blood. IL-12 is important to the induction of immunity because it is considered to be a major activator of the types of immune responses that are essential for controlling herpes outbreaks, including natural killer cells and T-cells which produce interferon gamma. It was further demonstrated that interferon gamma and CD4 expressing cells are important elements for initiating and expanding the response induced by CEL-1000 and for delivering the protection from herpes disease. These types of immune responses may also protect against vaccinia and smallpox.

Since the grant will also explore the value of CEL-1000 as an adjuvant for vaccinia vaccines, it is also important to note that CEL-1000 has been shown to be effective without an adjuvant and that it acted as an adjuvant itself in a separate animal study using CEL-1000 as a melanoma vaccine.

This grant was awarded following a peer review process.

CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases.

Source: CEL-SCI Corporation

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