TCA 650 therapy in the phase 2 trial was administered for the 90-day treatment period with a single insertion of ITCA 650 on day 1 and removal on or about day 90. The extension phase of the 2 trial evaluated higher doses of ITCA 650 using a single device to deliver 3 months of treatment. The phase 3 study planned for 2011 will evaluate treatment regimens involving initial 12-week ITCA 650 dosing at 20 mcg/day transitioning to 60 mcg/day thereafter using ITCA 650 devices of both 6- and 12-month duration.
A downloadable version of the ITCA 650 phase 2 presentation from ADA is available on the Intarcia corporate website at: http://www.intarcia.com/media_presentations.html
About ITCA 650ITCA 650 therapy for type 2 diabetes consists of DUROS continuous subcutaneous delivery of exenatide. Intarcia's delivery technology comprises the DUROS device, a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy, and proprietary formulation technology that maintains stability of therapeutic proteins and peptides at human body temperature for extended periods of time.
A single DUROS device can deliver up to a full year of ITCA 650 therapy. Unlike other extended delivery technologies, such as polymers or albumin fusions, DUROS delivery allows for steady state drug delivery upon insertion and near immediate withdrawal of therapy, if required. ITCA 650 is an investigational new drug and is not currently approved by any regulatory authority. Exenatide, the active agent in ITCA 650, has been approved in the U.S., Europe and many other markets and is currently marketed as a twice-daily self-injection therapy for type 2 diabetes.
About Type 2 DiabetesAccording to the National Institutes of Health (NIH), "Approximately 23.6 million Americans have type 2 diabetes, which represents 7.8 percent of the U.S. population and about 1/4 o
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. Intarcia Therapeutics Executive Chairman, Kurt Graves to Present at Lazard Capital Markets 7th Annual Healthcare Conference2
. Intarcia Therapeutics, Inc. Presents Positive Results from Two Studies of ITCA 650 for the Treatment of Type 2 Diabetes at the Ninth Annual Diabetes Technology Meeting3
. Intarcia Therapeutics, Inc. Presents Positive Results of ITCA 650 Phase 1b Study in Type 2 Diabetes at the European Association for the Study of Diabetes Conference4
. Intarcia Therapeutics, Inc. Commences Enrollment of ITCA 650 Phase 2 Study in Type 2 Diabetes5
. Intarcia Therapeutics, Inc. Presents ITCA 650 Phase 1b Study Results as a Late-Breaker at the American Diabetes Association 69th Scientific Sessions6
. Intarcia Therapeutics, Inc. Announces Acceptance of ITCA 650 Phase 1b Study for Late-Breaker Presentation at the American Diabetes Association 69th Scientific Sessions7
. Intarcia Therapeutics, Inc. Announces Appointment of Kenneth Luskey, M.D. as Vice President, Clinical Research8
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