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news.Oragenics has reported that Qualia Clinical Services, located in Omaha, Nebraska, has been selected to provide clinical site services for the company's recently approved Phase Ib safety trial.
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The trial will be conducted in compliance with the approved FDA protocol and is designed to evaluate the safety and tolerability of the company’s SMaRT Replacement Therapy in healthy, adult male subjects over a six-week period, with a long-term follow-up evaluation at six months.
Subject enrollment for the Phase Ib clinical trial is anticipated to begin in early 2008.
Robert Zahradnik, president and CEO of Oragenics, said: “This study represents an important milestone for advancing clinical knowledge regarding the replacement therapy concept as a means for treating or preventing bacterial infections.”