Intarcia Therapeutics, Inc. Announces Acceptance of ITCA 650 Phase 1b Study for Late-Breaker...

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Wed May 27, 2009 10:46am EDT

Intarcia Therapeutics, Inc. Announces Acceptance of ITCA 650 Phase 1b Study
for Late-Breaker Presentation at the American Diabetes Association 69th
Scientific Sessions

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.

James Ahlers of Intarcia Therapeutics, Inc., +1-510-782-7800,
james.ahlers@intarcia.com
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