WALTHAM, Mass., May 10 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) announced today positive results from a Phase 2 clinical
trial to evaluate the use of RG1068, synthetic human secretin, as an agent
to improve the assessment of pancreatic duct structures by magnetic
resonance imaging (MRI). The study showed an improvement in sensitivity of
detection of structural abnormalities of the pancreatic duct of
approximately 20% with no loss in specificity, consistent with prior data
and expectations. In addition, the study showed highly significant
increases in the following three assessments: physician confidence in their
ability to identify structural abnormalities, the number of pancreatic duct
segments visualized and improvement in the overall quality of the MRI
images. Detailed visual assessment of the pancreatic ducts and
identification of structural abnormalities is important in the assessment,
diagnosis and treatment of diseases such as acute and chronic pancreatitis.
This was a multi-center, baseline controlled, single dose study in
which 80 patients with a history of pancreatitis received a
secretin-enhanced MRI and an unenhanced MRI of the pancreas. All study
operations and data analyses were conducted with protocols previously
discussed with the U.S. Food and Drug Administration (FDA).
"We are pleased with the successful outcome of our first prospectively
defined, blinded, multi-center clinical study to assess the use of secretin
to aid in the detection of structural abnormalities of the pancreas,"
stated Walter C. Herlihy, President and Chief Executive Officer of
Repligen. "These quantitative results confirm what has previously been
reported by physicians, and establishes a sound basis for discussions with
the FDA regarding a clinical plan to receive marketing approval for
secretin for MRI imaging of the pancreas. We believe there may be more than
100,000 potential MRI images of the pancreas in the U.S. each year that
could benefit from the use of secretin."
Secretin is a natural gastrointestinal hormone involved in the process
of digestion. Secretin has been used for many years by gastroenterologists
in combination with endoscopy, an invasive procedure to evaluate and treat
diseases of the pancreas and gallbladder. There are risks associated with
the use of endoscopy, which have generated interest in the development of
safer non-invasive tests to diagnose gastrointestinal disorders. The use of
secretin in combination with a non-invasive procedure such as MRI to
improve the detection and delineation of normal and abnormal structures of
the pancreas and to quantify pancreatic fluid production, harnesses the
natural biologic properties of the hormone to increase the diagnostic
quality of the MRI image. The use of MRI is attractive for patient care as
it can obviate the need for more risky invasive procedures.
The use of secretin in abdominal imaging may have application beyond
improvements in detection of structural abnormalities. We are conducting
several pilot studies to evaluate the use of secretin with MRI to assess
among other things, the function of the pancreas. This study is based on
the clinical observation that patients with pancreatic diseases have a
reduced fluid production response to secretin stimulation and will be
designed to confirm and quantify this observation. The Office of Orphan
Products Development of the FDA granted Repligen orphan drug designation
for RG1068, synthetic human secretin, for use with MRI of the pancreas.
Orphan drug designation qualifies Repligen for seven years of exclusive
marketing rights in the United States if the company is first to receive
marketing approval for RG1068 for MRI imaging of the pancreas.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the
development of novel therapeutics for diseases that affect the central
nervous system. In addition, we are the world's leading supplier of
recombinant Protein A, the sales of which partially fund the advancement of
our development pipeline while supporting our financial stability.
Repligen's corporate headquarters are located at 41 Seyon Street, Building
#1, Suite 100, Waltham, MA 02453. Additional information may be requested
from http://www.repligen.com.
This press release contains forward-looking statements which are made
pursuant to the safe harbor provisions of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. The forward-looking statements in this release do not
constitute guarantees of future performance. Investors are cautioned that
statements in this press release which are not strictly historical
statements, including, without limitation, statements regarding current or
future financial performance and position, management's strategy, plans and
objectives for future operations, plans and objectives for product
development, plans and objectives for present and future clinical trials
and results of such trials, plans and objectives for regulatory approval,
litigation, intellectual property, product development, manufacturing plans
and performance such as the anticipated growth in the monoclonal antibody
market and our other target markets and projected growth in product sales,
constitute forward-looking statements. Such forward-looking statements are
subject to a number of risks and uncertainties that could cause actual
results to differ materially from those anticipated, including, without
limitation, risks associated with: the success of current and future
collaborative relationships, the market acceptance of our products, our
ability to compete with larger, better financed pharmaceutical and
biotechnology companies, new approaches to the treatment of our targeted
diseases, our expectation of incurring continued losses, our uncertainty of
product revenues and profits, our ability to generate future revenues, our
ability to raise additional capital to continue our drug development
programs, the success of our clinical trials, our ability to develop and
commercialize products, our ability to obtain required regulatory
approvals, our compliance with all Food and Drug Administration
regulations, our ability to obtain, maintain and protect intellectual
property rights for our products, the risk of litigation regarding our
intellectual property rights, our limited sales and manufacturing
capabilities, our dependence on third-party manufacturers and value added
resellers, our ability to hire and retain skilled personnel, our volatile
stock price, and other risks detailed in Repligen's filings with the
Securities and Exchange Commission. Repligen assumes no obligation to
update any forward-looking information contained in this press release or
with respect to the announcements described herein.
SOURCE Repligen Corporation
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Related links:
http://www.repligen.com/
CONTACT:
Walter C. Herlihy, Ph.D., President and Chief
Executive Officer, +1-781-419-1900, or Laura Whitehouse Vice
President, Market Development, +1-781-419-1812, both of Repligen
Corporation
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