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EnWave Announces Additional Positive Shelf-Life Results from Vaccine Dehydration Testing
(via Thenewswire.ca)
About this update from Enwave Corporation
[{"type":"text","content":"EnWave Announces Additional Positive Shelf-Life Results from Vaccine Dehydration Testing\n\n(via Thenewswire.ca)\nSeptember 25 2008 - EnWave Corporation (TSX-V: ENW) (\"EnWave\" or \"the Company\") today announced that it has received positive results from a second shelf-life study of dehydrated rotavirus vaccine conducted by its collaboration partner Aridis Pharmaceuticals, LLC (\" Aridis\") of San Jose, California using EnWave's bioREV technology.\n\nAridis and EnWave are working together to determine the feasibility of dehydrating vaccines and antibodies in sterile vials using EnWave's bioREV technology to produce room temperature stable products as a cost-effective alternative to the industry standard of freeze drying (\"lyophilization\"). Both companies believe that the production of dried vaccines and antibodies storable at room temperature could lead to an industry breakthrough by allowing world-wide shipment, unrefrigerated storage, and stockpiling to protect against pandemic diseases and bioterrorism threats.\n\nIn May 2008, EnWave announced results from a 12-week accelerated shelf-life study showing that a rotavirus vaccine sample dried using bioREV technology remained stable at temperatures of 25oC and 37oC, despite a residual moisture content of 6.5% which is higher than the industry standard. This test provided initial evidence that a high post-dehydration moisture level did not impact the shelf-life stability for the rotavirus vaccine sample over the 12 week time frame.\n\nToday, EnWave is announcing the completion of a 27-week accelerated shelf-life study for a rotavirus vaccine sample, dried to 5.54% moisture using a combination of bioREV technology and a conventional drying method. This second test showed that the sample remained stable at 25oC throughout the 27-week test period. The test also demonstrated shelf-life stability of over 5 months at 37oC. EnWave has since achieved less than 5.5% moisture using exclusively the bioREV technology on formulations developed by Aridis, and less than 3.5% moisture using freezeREV as announced on September 18, 2008.\n\nThe results from the current study compare favourably with manufacturer's data for the only commercially available lyophilized rotavirus vaccine currently on the market, Rotarix, which is confirmed stable at 37oC for one week. Additionally, the World Health ...