Navigation Links
Intarcia Therapeutics, Inc. Announces Acceptance of ITCA 650 Phase 1b Study for Late-Breaker Presentation at the American Diabetes Association 69th Scientific Sessions
Date:5/27/2009

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

HAYWARD, Calif., May 27 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced it will present clinical data from a phase 1b study of ITCA 650 (DUROS(R) continuous delivery of exenatide) for the treatment of type 2 diabetes as a late-breaker at the Annual Conference of the American Diabetes Association in New Orleans, LA (June 5-9, 2009). The study was conducted at multiple centers in the United States and evaluated a 4-week course of ITCA 650 treatment among 44 patients (n= 10-12 patients/dose arm) with type 2 diabetes.

(Logo: http://www.newscom.com/cgi-bin/prnh/20050301/SFTU126LOGO)

ITCA 650 Late-Breaker Abstract 4-LB in Category 01-C Clinical Therapeutics/ New Technology - Other Drug Delivery Systems:

A Phase 1b Study of ITCA 650: Continuous Subcutaneous Delivery of Exenatide via DUROS(R) Device Lowers Fasting and Postprandial Plasma Glucose - Luskey, K., McNally, J., Dahms, J., Logan, D., Weiner, G., Denham, D. and Alessi, T.

"We are very pleased the ADA scientific reviewers selected our study for presentation as a late-breaker," said Alice Leung, President & CEO of Intarcia Therapeutics, Inc. "Our team worked very hard to advance this program from an idea to clinical evaluation in under 18 months. In continuing this brisk pace, we expect to begin a phase 2 study of ITCA 650 in the second half of this year."

The late-breaker abstract describes the dose-ranging design of the study and preliminary results from the two lower doses of 10mcg/day and 20 mcg/day through the first two weeks of treatment. Based on the favorable tolerability of DUROS continuous delivery of exenatide on the lower doses, patients have been enrolled to two higher dose arms of 40mcg/day and 80mcg/day, and 4-week results from all four cohorts will be presented in the late breaker session at the American Diabetes Association Conference. Dr. Kenneth Luskey, VP, Clinical Research, at Intarcia will be available to answer questions on Saturday, June 6, from 6:15 pm until 7:30 pm, during the Poster Reception, and on Monday, June 8, from 12:00 noon until 2:00 pm, during the Poster Presentation Session in Hall E of the Morial Convention Center in New Orleans.

"We are very encouraged by the preliminary results of this first clinical study of ITCA 650," said Dr. Luskey. "We look forward to presenting a more complete analysis of 28-day results from all four dose arms at the ADA Conference."

ITCA 650 therapy in this phase 1 trial 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 have supported the selection of doses to be evaluated in a controlled phase 2 study planned to begin later this year. This phase 2 trial will evaluate ITCA 650 against current standard of care, with longer durations of treatment using 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 repeated injections.

About ITCA 650

ITCA 650 therapy for type 2 diabetes consists of DUROS continuous delivery of exenatide. The DUROS 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. The DUROS technology can deliver up to a full year of therapy from a single ITCA 650 insertion. 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 to manage side effects, if required. 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.

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 type 2 diabetes and hepatitis C.

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 biology technology :

1. Intarcia Therapeutics, Inc. Announces Appointment of Kenneth Luskey, M.D. as Vice President, Clinical Research
2. Prospect Therapeutics, Inc.s GCS-100 Inhibited Blood Vessel Formation in a Variety of Cancer Models
3. Cell Therapeutics, Inc. (CTI) to Present at 2009 BIO International Convention
4. Prospect Therapeutics, Inc. Assigns All Its Assets to Joseph F. Finn, Jr., C.P.A. for the Benefit of Its Creditors
5. Cell Therapeutics, Inc. (CTI) to Report 2009 First Quarter Financial Results on May 7
6. Oxygen Biotherapeutics, Inc. Signs Supply Agreement for Clinical-Grade Oxycyte for Clinical Trials and Future Needs
7. Cell Therapeutics, Inc. Announces Single Institutional Investor Purchases $15 Million of Preferred Stock
8. Oxygen Biotherapeutics, Inc. CEO Posts New Blog Entry
9. Stockholder Suits Related to TorreyPines Therapeutics, Inc. Dismissed
10. Webcast Alert: Oxygen Biotherapeutics, Inc. Investor Meeting in Zurich, Switzerland
11. Oxygen Biotherapeutics, Inc. Adds Oxycyte TBI Clinical Trial Sites in Israel
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... ... the launch of the Supplyframe Design Lab . Located in Pasadena, Calif., ... the future of how hardware projects are designed, built and brought to market. ...
(Date:6/23/2016)... 23, 2016 Apellis Pharmaceuticals, Inc. today ... trials of its complement C3 inhibitor, APL-2. The ... ascending dose studies designed to assess the safety, ... injection in healthy adult volunteers. Forty ... a single dose (ranging from 45 to 1,440mg) ...
(Date:6/23/2016)... On Wednesday, June 22, 2016, the ... the Dow Jones Industrial Average edged 0.27% lower to finish ... 0.17%. Stock-Callers.com has initiated coverage on the following equities: Infinity ... NKTR ), Aralez Pharmaceuticals Inc. (NASDAQ: ... ). Learn more about these stocks by accessing their free ...
(Date:6/23/2016)... Windsor, Connecticut (PRWEB) , ... June 23, 2016 ... ... will introduce a new line of intelligent tools designed, tuned and optimized exclusively ... place September 12–17 in Chicago. The result of a collaboration among several companies ...
Breaking Biology Technology:
(Date:6/22/2016)... Md. , June 22, 2016  The American College ... Trade Show Executive Magazine as one of the ... on May 25-27 at the Bellagio in Las ... on the highest percentage of growth in each of the ... of exhibiting companies and number of attendees. The 2015 ACMG ...
(Date:6/16/2016)... SAN FRANCISCO , June 16, 2016 /PRNewswire/ ... Market size is expected to reach USD ... report by Grand View Research, Inc. Technological proliferation ... and banking applications are expected to drive the ... ) , The development of ...
(Date:6/3/2016)... 3, 2016 Das ... Nepal hat ein 44 ... geprägter Kennzeichen, einschließlich Personalisierung, Registrierung und IT-Infrastruktur, ... Produktion und Implementierung von Identitätsmanagementlösungen. Zahlreiche renommierte ... Januar teilgenommen, aber Decatur wurde als konformste ...
Breaking Biology News(10 mins):