ALACHUA, FL--(Marketwire - October 31, 2007) - Oragenics, Inc. (AMEX: ONI) announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the most recent submission of its Investigational New Drug Application (IND) for SMaRT Replacement Therapy™ had satisfactorily addressed all outstanding clinical hold issues, and that the company may now proceed with its second Phase 1 clinical trial. The study protocol is designed as an open label, single dose study for the evaluation of the safety and tolerability of the SMaRT™ replacement strain, A2JM, in healthy, adult male subjects, and includes an institutionalized phase during the clinical trial.
