Navigation Links
Intarcia Therapeutics, Inc. Announces Completion of Enrollment of ITCA 650 Phase 1b Study for the Treatment of Type 2 Diabetes

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.


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 enhance the therapeutic effects of exenatide by ensuring patient compliance and providing more consistent, round-the-clock therapeutic drug levels; and to reduce side effects, including nausea, associated with high peak levels of exenatide exposure observed with injection administration. Unlike other extended delivery technologies such as polymers or albumin fusion, DUROS delivery allows for steady state drug delivery upon insertion and near immediate withdrawal of therapy to manage side effects, if required.

"We are very pleased with the rapid progress the Company has made with ITCA 650," said Alice Leung, President & CEO of Intarcia. "Our team has demonstrated the great potential for DUROS delivered therapies in advancing this important treatment candidate for type 2 diabetes patients from an idea to clinical stage development in 18 months."

ITCA 650 is the second DUROS delivery program Intarcia has moved into clinical development. In December 2008, Intarcia also completed enrollment of a phase 1b study for ITCA 638, which involves DUROS delivery of omega interferon for the treatment of chronic hepatitis C infection. "Many patients with type 2 diabetes are forced to manage dosing schedules and side effects of multiple drug therapies simultaneously to adequately control their disease," commented Ken Luskey, M.D., VP, Clinical Research at Intarcia. "We believe ITCA 650 will deliver improved glycemic control and provide a better tolerated, more convenient treatment option."

About Intarcia

Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to ensure enhanced treatment outcome by optimizing patient adherence and improving the convenience and tolerability of drug therapies. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above body temperature and to deliver them in a constant and consistent manner via the proprietary DUROS drug delivery platform. Intarcia is pursuing clinical stage development programs for hepatitis C and type 2 diabetes.

Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc. DUROS is a registered trademark of ALZA Corporation licensed to Intarcia Therapeutics, Inc. in certain fields.

SOURCE Intarcia Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkins Lymphoma (NHL)
2. Cell Therapeutics, Inc. (CTI) Sponsors Panel Discussion on Women and Lung Cancer on Capitol Hill
3. Cell Therapeutics, Inc. (CTI) Supports Panel Discussion on Women and Lung Cancer on Capitol Hill
4. Velcura Therapeutics, Inc. Reports Positive Pre-IND Meeting With FDA and Plans Early Clinical Trials for New Drug to Treat Multiple Myeloma Bone Disease
5. NIST Awards $2 Million to Velcura Therapeutics, Inc. for Innovative Technology R&D - Dual-Action Therapies for Bone Disease
6. Ocera Therapeutics, Inc. Completes Enrollment in FHAST1, a Pivotal Phase 3 Clinical Trial in Fistulizing Crohns Disease
7. William R. Ringo Joins Hyperion Therapeutics, Inc. Board of Directors as Chairman
8. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for XYOTAX(TM)
9. Dynamis Therapeutics, Inc. Discovers RAGE Inhibitor
10. Cell Therapeutics, Inc. (CTI) Announces Enrollment Complete in Phase III EXTEND (PIX301) Clinical Trial of Pixantrone in Patients With Second or Greater Relapse of Diffuse Large B Cell NHL
11. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
Post Your Comments:
(Date:12/1/2015)... , Dec. 1, 2015 Relmada Therapeutics, Inc. ... treatment of chronic pain, announced today that the company will ... be held December 1-3 at the Luxe Sunset Boulevard Hotel ... Traversa , CEO of Relmada Therapeutics, will present on Thursday, ... Time). . Please register at least 10 ...
(Date:12/1/2015)... 2015 CytRx Corporation (NASDAQ: CYTR ), ... today announced that it has reached its enrollment target ... 3 clinical trial of aldoxorubicin in patients with previously ... be completed in Q1 2016. The Phase 3 trial is ... Protocol Assessment from the FDA at 79 sites in ...
(Date:12/1/2015)... , Dec. 1, 2015  Today, ... the launch of CareFront, a first-of-its-kind population health ... diagnosed with cancer. Designed to be built into ... cancer patients with resources for their care and ... program also offers tools to help patients understand ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... ... Growth in medical payments per workers’ compensation claim in Louisiana slowed from 2011 ... according to a recent study by the Workers Compensation Research Institute (WCRI). , ... per claim with more than seven days of lost time continued to be higher ...
(Date:12/1/2015)... Wayland, MA (PRWEB) , ... December 01, 2015 , ... ... adults has a tattoo — a number even greater among Millennials (a whopping one ... there are more and more people who are dissatisfied with their ink. In fact, ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... technicians must mark the film for accurate interpretation by the radiologist. The marking ... an inventor from Sacramento, Calif., has found a way to alleviate this problem. ...
(Date:12/1/2015)... ... 01, 2015 , ... Next IT Healthcare, the leader in ... this year’s Fierce Innovation Awards: Healthcare Edition, an awards program from the publisher ... in the category of Digital Solutions for its innovative, industry-leading product, Alme Health ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... Effective Post-Affiliation Integration ,” addresses a main “pain point” for merging or aligning ... results, once a deal is signed. This quick-read guidance suggests that failing ...
Breaking Medicine News(10 mins):