BioDelivery Sciences International, Inc. has initiated its first phase-1 clinical study assessing the safety, tolerability and pharmacokinetics of Bioral Amphotericin B. This study represents a significant step forward in the evaluation of BDSI's second drug delivery platform, known as Bioral.
The 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 (IV) injection.
"Development of an orally available formulation of Amphotericin B has been a long-term goal of our research laboratory," stated Dr Raphael Mannino, executive vice president and chief scientific officer at BDSI. "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 IV therapy. We have conducted several studies in animals showing the efficacy and safety of the technology and have collaborated with other companies in an attempt to provide better stability and oral delivery of their products. This includes programs involving siRNAs, where the greatest challenge is drug delivery. We are also enthusiastic about our collaboration with the National Institutes of Health (NIH), which has supported in part our preclinical program, and more recently our collaboration with the Walter Reed Army Institute of Research exploring the use of the Bioral technology in difficult to treat infections," Dr Raphael said.
Dr Mark Sirgo, president and CEO of BDSI stated, "We believe that the initiation of this first clinical study with our Bioral delivery technology represents a major milestone for BDSI. We believe that the availability of an oral formulation of Amphotericin B could have very positive public health benefits. Our intention is to evaluate its use for the treatment and prophylaxis of various fungal infections including Candidiasis. This gives BDSI the opportunity to provide the first oral Amphotericin B formulation and enter the over $3 billion global market for systemic antifungal agents. We are hopeful that Bioral Amphotericin B will be the first product of several in our pipeline using the Bioral drug delivery technology."
The company's lead product, BEMA Fentanyl, is currently under review at the FDA with a PDUFA date of August 31, 2008. BEMA Fentanyl consists of a small, thin, soluble, polymer film, formulated with the opioid fentanyl for application to the buccal (inner lining of cheek) membranes and is being developed to treat breakthrough pain in opioid tolerant patients with cancer.
BioDelivery Sciences International, Inc. is a pharmaceutical company that is specially focused on developing innovative products to address growing market opportunities, including conditions such as pain.