September 25 2008 - Vancouver - 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.
Aridis 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.
In 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.
Today, 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.
The 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 Organization categorizes vaccines which do not lose their potency when kept for 30 days at 37oC as highly stable.
"The stability results achieved from these tests, combined with promising post-dehydration recovery levels, indicate that the bioREV technology is capable of dehydrating rotavirus vaccines using the small-scale single-vial process," said Dr. Vu Truong, Aridis' Vice President of R&D. "We encourage EnWave to keep developing this technology to establish a reliable commercial-scale method."
The success of these results combined with EnWave's recent announcement of a new lower moisture freezeREV platform has expanded the company's technology options for processing liquid pharmaceuticals using two distinct methods:
· bioREV - high-speed dehydration of live pharmaceuticals at temperatures above the freezing level; an attractive method for formulations vulnerable to damage from low temperatures. EnWave has been able to achieve moisture levels as low as 3% using bioREV, demonstrating potential for applications such as bacterial cultures, enzymes and other proteins.
· freezeREV - high-speed dehydration of live pharmaceuticals from the frozen state; a microwave-assisted method for freeze drying where low moisture levels are shown to be imperative to shelf-life stability.
Both methods dry live pharmaceutical formulations in minutes compared to multiple days required for conventional freeze drying used widely by the pharmaceutical industry. Both technologies are designed to offer the potential for significant reductions in processing costs through energy and time savings.
"Our experience in drying a wide range of biological materials indicate that moisture levels, post-dehydration bioactivity, and shelf-life stability can vary depending on the unique characteristics of each individual formulation or product," said Dr. Tim Durance, EnWave's Co-CEO. "I believe that both the bioREV and freezeREV options could offer significant commercial advantages to the pharmaceutical processing sector, and I am looking forward to expanding our testing program to demonstrate these advantages."
EnWave has recently expanded its engineering resources, developed a commercial-scale bioREV design, and is exploring ways to commercially scale up the freezeREV method. In addition to the recent patent application filed for freezeREV, the company has also filed a PCT international patent for the bioREV methodology and equipment expanding the claims from the US patent filed on the bioREV technology last year.
The company plans to continue working together with Aridis for the next six months to test a number of new vaccine formulations using both bioREV and freezeREV technology. EnWave is also currently searching for a collaboration partner with freeze drying manufacturing experience to support commercialization of its technology platforms.
Aridis is a privately held biopharmaceutical company formed in 2003, which uses pioneering formulation, processing, and delivery technologies to produce differentiated, high value products. Aridis' goal is to develop therapeutics and vaccines that are more convenient and cost effective for both the recipient and the health professional by simplifying their storage and administration. Their initial products target infectious diseases that have a significant impact on life expectancy, such as infectious diseases in children and cystic fibrosis (CF) in adults and children. Aridis has three licensed products: two with preclinical data, and one with phase II clinical efficacy data. More information about Aridis is available at www.aridispharma.com.
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