WALTHAM, Mass., June 8 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today announced that the Company has initiated a clinical
trial to evaluate the use of RG1068, synthetic human secretin, as an agent
to improve the detection of structural abnormalities of the pancreatic
ducts during MRI imaging of the pancreas. This is a multi-center, baseline
controlled, single dose study in which 80 patients with a history of
pancreatitis will receive a secretin-enhanced MRI and an unenhanced MRI of
the pancreas. This study will assess the sensitivity and specificity of
secretin-enhanced MRI to improve the ability to detect pancreatic duct
abnormalities relative to unenhanced MRI as well as the safety of secretin
in combination with MRI. This study is being initiated at approximately
8-10 clinical sites. Discussions with the FDA have resulted in a consensus
on the design of a clinical study to support this indication including
patient selection, study operations and endpoints.
"Following extensive discussions with the FDA, we believe this clinical
study will provide meaningful data on 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. "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, which has been used for decades in the assessment of
pancreatic exocrine function. More recently, secretin has gained
acceptance, especially in Europe, for use with abdominal MRI imaging to
improve visualization of pancreaticobiliary structures and to increase
diagnostic sensitivity relative to unenhanced abdominal MRI. MRI technology
images stationary water thus the use of secretin during MRI harnesses the
natural biologic properties of secretin which signals the release of
water-rich fluids into the ducts of the pancreas. Improvement in the
detection and delineation of normal and abnormal structures with 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 currently in
the final stages of initiating 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.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company committed to being
the leader in the development of novel therapeutics for profound
neuropsychiatric disorders and autoimmune disease. Repligen has a Specialty
Pharmaceuticals business comprised of rProtein A(TM) and SecreFlo(R), the
profits from which will be used to partially support the development of our
proprietary products. 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 size of the pancreatic assessment market when
using secretin 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.
CONTACT:
Walter C. Herlihy, Ph.D.
President and Chief Executive Officer
(781) 419-1900
Laura Whitehouse
Vice President, Market Development
(781) 419-1812
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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