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GI Dynamics, Inc. Initiates U.S. Pivotal Clinical Trial of EndoBarrier®



  GI Dynamics, Inc. Initiates U.S. Pivotal Clinical Trial of EndoBarrier®

Business Wire

LEXINGTON, Mass. & SYDNEY -- January 15, 2013

GI Dynamics, Inc. (ASX: GID) today announced that it has initiated its U.S.
multicenter pivotal clinical trial of EndoBarrier®, the ENDO Trial, for the
treatment of patients who have uncontrolled type 2 diabetes and are obese.

EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical
barrier between food and a portion of the wall of the intestine. In previous
clinical studies, EndoBarrier has been shown to achieve rapid reductions in
blood sugar levels and weight loss of approximately 20 percent in 12
months.^1, 2 EndoBarrier received CE Mark approval in 2010, and approval by
the Therapeutic Goods Administration in Australia in 2011 for the treatment of
type 2 diabetes and/or obesity for up to 12 months.

“We’re excited to initiate this important trial in the U.S.,” said Lee M.
Kaplan, M.D., Ph.D., lead investigator and director of the Obesity, Metabolism
& Nutrition Institute at the Massachusetts General Hospital and Harvard
Medical School. “Results from the pilot studies of EndoBarrier have been very
promising, and we look forward to determining the efficacy and safety of this
device in this large, controlled, pivotal trial.”

People interested in learning more about the ENDO Trial should visit
www.endobarriertrial.com or call 1-888-9STUDY9 (1-888-978-8399).

“The start of our U.S. pivotal trial marks a major milestone on the road to
bringing EndoBarrier to the millions of people in this country living with
type 2 diabetes,” said Stuart A. Randle, president and chief executive
officer, GI Dynamics. “We appreciate the support of our investigators and
clinical trial sites as we begin the process of enrolling patients and
executing this landmark clinical trial.”

About EndoBarrier

EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical
barrier between food and a portion of the wall of the intestine. In 12
clinical studies conducted outside the United States and one conducted in the
United States, with more than 500 patients, EndoBarrier has been tested in
similar patient populations. EndoBarrier received CE Mark approval in 2010,
and approval by the Therapeutic Goods Administration in Australia in 2011 for
the treatment of type 2 diabetes and/or obesity for up to 12 months.
EndoBarrier is now pursuing commercial status in the United States. The first
step in this process is a successful completion of the ENDO Trial. The device
was developed by GI Dynamics, Inc., based in Lexington, Mass. More information
about the company may be found at www.gidynamics.com.

About the ENDO Trial

The ENDO Trial is a randomized, double-blind, sham controlled, multi-center
trial that is expected to enroll approximately 500 people living with
uncontrolled diabetes and obesity who meet specific enrollment criteria at up
to 25 sites in the United States. The trial is designed to assess improvements
in diabetes over a treatment period of up to 12 months. The primary endpoint
of the trial is improvement in HbA1c (a key blood sugar measure for diabetes);
secondary measures include weight loss and improvement in select
cardiovascular risk factors, such as cholesterol.

About Type 2 Diabetes and Obesity

Estimates indicate that type 2 diabetes affects more than 23 million people in
the United States,^3 and approximately 320 million people worldwide.^4 Type 2
diabetes, which accounts for approximately 90 percent of all cases of
diabetes, occurs when the pancreas has reduced effectiveness in insulin
production associated with an increase in insulin resistance. The diagnosis of
type 2 diabetes usually occurs after the age of 40 and is often, but not
always, associated with obesity.

About GI Dynamics

GI Dynamics, Inc. (ASX: GID) is pioneering the development and
commercialization of effective, non-surgical treatments targeting the large
and growing global patient populations with type 2 diabetes and obesity. The
company’s flagship product, EndoBarrier®, is a novel, non-surgical device
proven to lower blood glucose levels and promote weight loss in diabetic
patients and/or obese patients during the implant period. GI Dynamics
currently markets EndoBarrier in select regions in Europe, South America and
Australia and is planning near-term commercial expansion into additional
markets. EndoBarrier is not approved for sale in the United States and is
considered investigational. Founded in 2003, GI Dynamics is headquartered in
Lexington, Massachusetts. For more information, please visit
www.gidynamics.com.

Forward-Looking Statements

This announcement contains or may contain forward-looking statements that are
based on management’s beliefs, assumptions and expectations and on information
currently available to management. All statements that address operating
performance, events or developments that we expect or anticipate will occur in
the future are forward-looking statements, including without limitation our
expectations with respect to our ability to commercialize our EndoBarrier®
including our estimates of potential revenues, costs, profitability and
financial performance; our ability to develop and commercialize new products
including our ability to obtain reimbursement for our products; our
expectations with respect to our clinical trials, including enrollment in or
completion of our clinical trials and our associated regulatory submissions
and approvals; our expectations with respect to the integrity or capabilities
of our intellectual property position. Management believes that these
forward-looking statements are reasonable as and when made. You should not
place undue reliance on forward-looking statements because they speak only as
of the date when made. GI Dynamics does not assume any obligation to publicly
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise. GI Dynamics may not actually achieve
the plans, projections or expectations disclosed in forward-looking
statements, and actual results, developments or events could differ materially
from those disclosed in the forward-looking statements. Forward-looking
statements are subject to a number of risks and uncertainties, described in
“Risk Factors” in our Prospectus lodged with the Australian Securities &
Investments Commission on 3 August 2011.

^1 Moura, GHD, et al, One Year Results of an Endoscopic, Duodenal-Jejunal
Exclusion Device for Weight Loss and Control of Type 2 Diabetes. Hospital das
Clinicas, University of São Paulo, São Paulo, Brazil. DT&T, February 2012, vol
14, no.2:183-189.

^2 Escalona, A., et al, “Post-explant follow-up after 12 months implantation
of an endoscopic duodenal-jejunal bypass liner.” Department of Digestive
Surgery. Faculty of Medicine Pontificia Universidad Católica de Chile. Annals
of Surgery, June 2012, Vol 255, Issue 6, p 1080–1085.

^3 Centers for Disease Control and Prevention. National diabetes fact sheet:
national estimates and general information on diabetes and prediabetes in the
United States, 2011.

^4 International Diabetes Federation, 5th edition of the Diabetes Atlas, 2011

Contact:

Investor Enquiries:
United States
GI Dynamics, Inc.
Robert Crane, +1 781-357-3250
Chief Financial Officer
or
Media Enquiries:
United States
Pure Communications Inc.
Carrie Sessine, + 1 773-457-9744
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