FluGen, Inc. announced today that all subjects have completed dosing in a first-of-its-kind clinical study which challenged subjects with an influenza virus that was intentionally mismatched by six years from the influenza strain utilized in FluGen’s M2SR vaccine.

The primary endpoint of the study is influenza infectivity in the placebo group compared to the group vaccinated with FluGen’s novel intranasal M2SR vaccine. Safety and immunogenicity data also will be evaluated for all subjects.

“Since 2004, there have been at least five influenza seasons where the recommended influenza vaccine has not matched one of the common circulating strains in the U.S., which has resulted in lower vaccine efficacy with a result of significant breakthrough illnesses and mortality. Imagine if a vaccine could protect people from the flu, even when such a mismatch occurs. The implications for improvement of influenza vaccine efficacy are significant,” said Robert Belshe, M.D., chair of the FluGen clinical advisory board and the Diana and J. Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology, Emeritus, at Saint Louis University.

The FluGen vaccine utilizes a proprietary M2 deleted, single replication (M2SR) influenza virus. The M2 gene is essential for the influenza virus to spread in the patient and the deletion of the M2 gene restricts the virus to a single replication cycle in the host. The body recognizes M2SR as an influenza infection and activates its robust immune response, but, because the virus can only replicate once, it cannot spread to other cells and cause symptoms of a real-world infection. Read the full story here.