|>>HAYWARD, Calif., Oct. 13 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq: ARDM - News) today announced positive results from the Clinical Performance Verification (CPV) Trial of its Intraject needle-free delivery system. Results from the trial showed that the study met its primary endpoint of demonstration of successful injection performance with Intraject with an excellent reliability profile.|
The trial demonstrated acceptable performance and delivery consistency of the selected configuration in 194 healthy subjects who were each given multiple injections of saline via Intraject. In total, there were 1152 injections with no occurrence of injection-related adverse events and no reliability issues such as glass breakage or malfunctions. Subjects rated their injections as causing little or no pain sensation, a result in line with numerous other studies previously conducted with Intraject. In addition, the majority of subjects responded that they preferred the use of the Intraject device to a standard needle injection.
"This trial was the final stage of technical development for Intraject and clearly demonstrates that the technological and design issues that faced the system prior to our acquisition of the Intraject technology have been fully addressed," said Dr. Bryan Lawlis, President and Chief Executive Officer of Aradigm. "The CPV data and extensive reliability testing conducted on the final Intraject configuration in parallel with this study exceed the performance requirements for Intraject. In addition, we have made excellent progress with our contract manufacturers towards process scale-up for registration and commercial manufacturing. This strong technical foundation lets us initiate the partnering of the platform to companies for use with their drugs, as well as allowing us to commence clinical trials using Intraject with a drug of our own choosing. We expect to complete and announce the selection of the drug by the end of the year with the objective of commencing pivotal trials for regulatory submissions in the second half of next year."<<