DOR BioPharma Reports Achievement of Two-Year Stability Milestone for RiVax(TM), Its Vaccine Against Ricin Toxin
Tuesday January 29, 7:00 am ET
DOR Submits Application for RiVax(TM) in Response to BARDA Biodefense RFP
EWING, NJ--(MARKET WIRE)--Jan 29, 2008 -- DOR BioPharma, Inc. (OTC BB:DORB.OB - News) ("DOR" or "The Company") announced today that it has successfully achieved a two-year milestone in the long-term stability program of the key ingredient of RiVax(TM), a recombinant subunit vaccine against ricin toxin. RiVax(TM) is intended to protect against exposure to ricin toxin that might result from the purposeful release of ricin in an aerosolized form, or as a poisonous contaminant in food or water.
The results of the two-year analysis undertaken as part of the formal stability program demonstrate that the immunogen component of RiVax(TM), a recombinant derivative of the ricin A chain, is stable under storage conditions for at least two years without loss of its natural configuration or the appearance of any detectable degradation products. A vaccine is considered by many to be the best way to prospectively protect populations at risk of exposure against ricin toxin. As this vaccine would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack, the activity of the vaccine must be maintained over a period of years under stockpile storage conditions.
Robust stability is one of the key factors stipulated by the Biomedical Advanced Research and Development Authority (BARDA) for vaccines to be included in the Strategic National Stockpile. BARDA has placed a priority on stability and a rapid onset of immunity in no more than two vaccine doses as the stability and efficacy targets for vaccines under development for both category A and category B vaccines. BARDA has recently issued a Request for Procurement (RFP) entitled "Biodefense Vaccine Enhancement," to which DOR has submitted an application for RiVax(TM). BARDA is a new agency within the US Department of Health and Human Services (HHS) established to implement acquisition under the Project Bioshield Act and to foster the development of vaccines and countermeasures such as RiVax(TM) that have achieved milestone hurdles, and are candidates for continued development. To this end, BARDA has solicited proposals in a number of key areas, including development of vaccines for category categories B and A that have enhanced stability properties that address long-term storage and the benefit of rapid onset of immunity. DOR regularly applies for biodefense grants, as well as RFPs when appropriate, from the National Institutes of Health (NIH) and other applicable governmental bodies that support biodefense.
"We believe that RiVax(TM) is a useful countermeasure against ricin toxin, and that our vaccine incorporates many of the desirable properties that should make it amenable to long-term stability as part of the overall mission to develop countermeasure components for the Strategic National Stockpile," said Robert N. Brey, PhD, Chief Scientific Officer of DOR. "The potential use of ricin toxin as a weapon of mass destruction was recently identified by the FBI as one of the top two bioterror threats this country faces. We have previously completed a Phase 1 clinical trial of RiVax(TM) which demonstrated both safety and immunogenicity, and we are also able to produce RiVax(TM) under GMP conditions at large scale."
DOR has studied the stability of the RiVax(TM) immunogen using a variety of spectral techniques aimed at examining the three-dimensional and two-dimensional structure of the protein, as well as other techniques that detect small changes in the nature of the protein during exposure to elevated temperature conditions. These results have shown that certain common materials can be added to solutions of the protein to maintain the stable configuration that is thought to be correlated with optimal immune response in animals. Without stabilization of the protein structure, the ricin A chain subunit component is extremely sensitive to elevated temperatures and forms aggregates and other complexes that negatively affect shelf life. |
