In preclinical studies sponsored by the National Institute of Allergy and Infectious Diseases, intranasal administration of RD-Ad5 vectors modulated the innate immune response to lethal challenge with a respiratory virus in mice and protected them from death. The immunomodulatory effects resulted in significantly decreased cellular inflammation and lower concentrations of IL-6 and other inflammatory cytokines in the lungs of treated animals compared to controls. Excessive production of inflammatory cytokines like IL-6 has been associated with the lung pathology and death in *redacted*. The protective effects were independent of any specific immunity or vaccine effects against the challenge virus. These protective effects were only observed with intranasal administration of RD-Ad5, and intramuscular administration provided no survival benefit.
The company believes that treatment with T-*redacted* administered as a single intranasal dose to patients with an early onset of symptoms and recent diagnosis of *redacted* may prevent the progression to severe lung inflammation and thereby decrease the development of severe *redacted* and the need for hospitalization. The FDA has agreed that the Company may use its existing lot of RD-Ad5-based NasoVAX influenza vaccine for the planned T-*redacted* clinical trial allowing the company to immediately initiate the study.