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news.BioDelivery Sciences International has initiated its first Phase I clinical study assessing the safety, tolerability and pharmacokinetics of Bioral amphotericin B. This study is said to represent a significant step forward in the evaluation of BDSI's second drug delivery platform, known as Bioral.
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BioDelivery Sciences International’s (BDSI) Bioral drug delivery system appears to protect certain drugs from degradation in the gastrointestinal tract and facilitates their oral absorption through a novel process of encapsulation.
In the Phase I trial, the Bioral technology will be evaluated as a potential means of orally delivering the antifungal agent Amphotericin B, an important and well established treatment for serious fungal infections, which is currently administered only by intravenous injection.
Raphael Mannino, chief scientific officer of BDSI, said: “The ability to orally administer amphotericin B using the Bioral technology could have a major impact on treatment approaches for systemic fungal infections which often require hospitalization and intravenous therapy.”