Intarcia Therapeutics, Inc. Announces Completion of Enrollment of ITCA 650 Phase 1b Study for the Treatment of Type ...( First study evaluating DUROS(R) conti...),Health

First study evaluating DUROS(R) continuous delivery of exenatide for the treatment of type 2 diabetes

HAYWARD, Calif., April 24 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced the completion of patient accrual to a phase 1b clinical study evaluating ITCA 650 (DUROS(R) continuous delivery of exenatide). The study is being conducted at multiple centers in the United States and involves the treatment of 44 patients with type 2 diabetes for a period of 4 weeks.

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Intarcia began the development of ITCA 650 in 2007 after acquiring an exclusive worldwide license to the DUROS delivery technology. The DUROS delivery technology consists of 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. Exenatide, the active agent in ITCA 650, has been approved in the US, Europe and many other markets and is currently marketed as a twice-daily self-injection therapy for type 2 diabetes.

Intarcia's phase 1 study is evaluating the safety and pharmacokinetics of ITCA 650 at several doses over a treatment period of 4 weeks. ITCA 650 therapy is administered for the full course of therapy with a single insertion of the DUROS device on day 1 and removal on day 29. Results of the phase 1 study will support selection of doses to be evaluated in a controlled phase 2 study planned for later in 2009 in which longer durations of treatment with a single ITCA 650 insertion will be evaluated. The DUROS technology can deliver up to a full year of therapy from a single ITCA 650 insertion. The goals of the ITCA 650 program are to enha
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