Ampligen-FluMist nasal trial begins

Hemispherx Biopharma's ($HEB) RNA-based adjuvant, Ampligen (rintatolimod), is being tested intranasally for the first time in humans in combination with AstraZeneca's ($AZN) nasal flu vaccine FluMist. The combination has been tested in animals, and the study, now under way at the University of Alabama at Birmingham, will evaluate its safety and effectiveness versus FluMist alone.

Preclinical research carried out in Japan showed that Ampligen could amplify the immune response to influenza vaccines. The combination could even help provide cross-protection to other flu virus strains.

Humans have a mucosal immune response, thus helping protect the body against inhaled bacteria and viruses, and the Ampligen/vaccine combination could tap into this. And researchers are indeed encouraged. "We are excited about commencing this study, which utilizes the mucosal immune system and thus offers significant potential to protect large numbers of individuals by administering enhanced flu vaccines," stated Dr. Paul Goepfert, associate professor of medicine in the Division of Infectious Diseases and director of the Alabama Vaccine Research Clinic.

If this study proves successful, Hemispherx hopes to extend studies into elderly people, who do not always mount a good immune system response to vaccines and may be vulnerable to infections.

The testing also is another approach toward the market for Ampligen, which has been in development for roughly three decades. In that time, the company has applied for the drug's approval in chronic fatigue syndrome (although the FDA requested more data) and studied it in HIV/AIDS and cancer.

- read the press release