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Study Shows Bioral(R) Delivery Technology Delivers Influenza siRNA Therapeutic and Reduces Virus Levels By 200 Times in Mice

Posted on: Wednesday, 9 August 2006, 09:00 CDT

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is using its patented Bioral(R) (Nanocochleate(TM)) delivery technology to deliver a siRNA therapeutic in a mouse model of influenza. The siRNA being used targets critical gene segments shared by avian influenza (H5N1). BDSI's licensed and patented Bioral(R) drug delivery technology encapsulates and protects the selected therapeutic in a nanocrystalline structure termed a "cochleate". All of the components of the cochleate are naturally-occurring substances.

In the animal model, a single intranasal dose of encochleated siRNA administered four hours after influenza exposure reduced virus titers in the lung by 200 times. Intravenous administration was also carried out in this animal model. Compared to naked (non-encochleated) siRNA, the encochleated siRNA was approximately 25 times more effective in reducing the virus using intravenous systemic delivery.

The concept behind siRNA technology is that it triggers a cellular response that destroys molecules which produce virus proteins within the cell. When these proteins are destroyed, the virus cannot replicate and cause disease. The experiments were done by an independent commercial collaborator who is testing its proprietary, specific siRNA sequences against influenza.

Dr. Raphael J. Mannino, Executive Vice President and Chief Scientific Officer of BDSI, stated, "Encochleated RNAi formulations represent an exciting and promising new area of medical therapeutics. Therapeutic siRNAs have the potential to transform the pharmaceutical industry by reducing the considerable time and expense needed in order to find traditional small molecule drugs. These therapeutic siRNAs may be used to treat human diseases, including influenza, a major disease that kills 36,000 people and debilitates many more in the U.S. alone each year. Influenza is a considerably more pressing problem in third world countries. For the treatment of viral infections, either due to natural viruses such as a potential pandemic like influenza, or due to bioterrorism from man-made variants, encochleated RNAi formulations may offer the opportunity for accelerated development of effective, targeted therapeutics to meet these needs."

"The challenge in developing siRNA therapeutics, however, is the fragile nature of unprotected siRNA molecules, which results in rapid destruction of the siRNA sequences following administration", Dr. Mannino continued. "For example, siRNA administered intravenously is destroyed rapidly in the plasma reducing the chances of demonstrating effectiveness. At this point in the evolution of siRNA therapeutics, the challenge is to find effective ways to formulate and deliver siRNA molecules which allow siRNAs to get safely to their therapeutic target. Based on these study results, it appears that our Bioral(R) delivery technology has enabled us, through nano-encapsulation of the siRNA molecules, to provide a potentially efficient and effective delivery system which we hope will replicate in future human studies. These results complement BDSI's extensive intellectual property portfolio for the Bioral(R) delivery technology and provides us with supportive data that could potentially contribute to additional commercial opportunities with other siRNA therapeutics."

Dr. Mark A. Sirgo, President and CEO of BDSI said, "The data from this study represents a milestone in the development of nucleic acid based therapeutics and an important validation of our Bioral(R) delivery technology, although much work remains to further develop and commercialize this opportunity. With these results in hand, we believe we have created the potential to systemically deliver these agents utilizing our proprietary Bioral(R) technology, thereby opening up a broad range of possible therapeutic options which were not previously available. The broad applicability could allow BDSI and our potential partners the ability to develop new therapies across a wide variety of diseases."

Dr. Sirgo added, "We are pleased to have engaged in these activities around our Bioral(R) technology in exactly the manner we have previously outlined; namely, in a cost saving collaboration with a third party. These initiatives have allowed the Bioral(R) program to advance while simultaneously focusing and spending the bulk of our financial resources on our BEMA(TM)-based products, including our flagship BEMA(TM) Fentanyl product for the treatment of 'breakthrough' cancer pain, which is currently in Phase III trials."

About the Bioral(R) (Nanocochleate(TM)) Delivery System

The Bioral(R) drug delivery technology is based upon encapsulating (or "encochleating") drugs in a multilayered, lipid crystal matrix (a cochleate) to potentially deliver the drug safely and effectively. Nanocochleate(TM) technology utilizes components which are non-toxic: phosphatidylserine and calcium. Along with intranasal and intravenous routes of drug administration, nanocochleate technology potentially enables oral availability of a broad spectrum of compounds, such as those with poor water solubility, and protein and peptide biopharmaceuticals, which have been difficult to administer. BDSI's lead product in the Bioral(R) technology is Bioral(R) Amphotericin B which is being developed for fungal infections. BDSI is the exclusive, worldwide licensee of the Bioral(R) technology.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is focused on developing innovative products to treat acute conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop and commercialize, clinically-significant new products using proven therapeutics. BDSI's pain franchise currently consists of two products in development utilizing the company's patented BEMA(TM) oral adhesive disc technology: BEMA(TM) Fentanyl, a treatment for "breakthrough" cancer pain which is expected to complete its Phase III BEMA Fentanyl trials during the second half of 2006, and BEMA(TM) LA, a second analgesic with a target indication of the treatment of moderate to severe pain, which is currently in Phase I trials and on which the company intends to initiate Phase III trials in the second half of 2006. The company is also working with both its BEMA(TM) technology and its patented Bioral(R) nanocochleate technology on products targeted at other acute treatment opportunities such as insomnia, nausea and vomiting, and infections. The company's headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com.

Forward-Looking Statements

Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the results of scheduled or additional clinical trials and FDA review of the Company's formulations and products, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). Peak sales estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all.

Source: Business Wire

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