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Repligen Discovers
Site of Brain Activation by Secretin in Animal Studies -- Repligen and McLean
Hospital to Extend Discovery Through Clinical Trial
Story Filed: Monday,
November 12, 2001 6:00 AM EST
NEEDHAM, Mass., Nov 12,
2001 /PRNewswire via COMTEX/ -- Repligen Corporation (Nasdaq: RGEN) reported
today that studies in animals demonstrate that secretin specifically activates
neurons in the amygdala, a part of the brain known to be important in social
interactions. Several studies in other laboratories have previously established
that people with autism do not show normal activation of the amygdala when
engaged in social interactions such as recognizing emotions from facial
expressions. Secretin is currently being evaluated by the Company for the
improvement of reciprocal social interaction in children with autism; however,
to date there has been no biological model for how secretin, a gastrointestinal
hormone, may affect the brain. Results from two animal studies provide, for the
first time, evidence of a biological mechanism for the action of secretin in
autism. The findings were presented at the annual meeting of the Society for
Neuroscience and the International Meeting for Autism Research on November
9-11. Separately, Repligen announced that it would collaborate with McLean
Hospital, a teaching facility for Harvard Medical School, to conduct a clinical
trial using functional Magnetic Resonance Imaging (fMRI) to extend this
research to humans.
The first study
establishing the activation of the amygdala by secretin was performed in
collaboration with researchers at the VA Medical Center in Boston and Harvard
Medical School. In this study, neuronal activation in rats was evaluated 1-2
hours following administration of a single intravenous injection of secretin or
a placebo. The brain tissue was fixed and stained for Fos, a readily measured
and well-established marker of the activation of neurons. Prominent activation
of the amygdala was observed only in secretin- treated animals. Additional
analysis revealed a significant decrease in the level of the neurotransmitter
serotonin in the amygdala of secretin-treated rats which was not observed in
rats treated with a control injection.
A second study, performed
in collaboration with the VA Medical Center in Saint Louis and Saint Louis
University School of Medicine, established the ability of a biologically
active, radioactive secretin analog to transfer out of the blood and enter the
brain. The rate of entry of secretin into the brain was similar to other
peptides with known neurological activity.
Repligen also presented
data from its Phase 2 clinical trial which demonstrated that a subset of the
autistic patients showed a clinical response to secretin. Symptom improvements
were most evident in reciprocal social interaction as measured with the Autism
Diagnostic Observation Schedule (ADOS), a standardized method for quantifying
the severity of the symptoms of autism.
"Taken together, these
studies show that secretin can activate a part of the brain involved in social
interaction and known to have reduced activity in autism," stated Walter
C. Herlihy, Ph.D., President and Chief Executive Officer of Repligen
Corporation. "We look forward to extending these results through our
collaboration with the Brain Imaging Center at McLean Hospital."
The Amygdala and Autism
The amygdala is part of a
complex neural system that is critical for ascribing emotional value to stimuli
and influencing affective responsiveness and emotional learning. One of the
core deficits of autism is impaired reciprocal social interaction including eye
contact, joint attention and an inability to deduce the mental states of others
from facial expressions. Although neuropathological and imaging studies have
revealed abnormalities in several regions of the brain in autism, a lack of
activation of the amygdala is recognized as an important correlate of the
social deficits of autism.
The role of the amygdala in
social interaction has been studied in both normal and autistic patients using
various neuroimaging tools. Studies using fMRI, have established an activation
of the amygdala when processing and responding to social stimuli. Reduced
activation of the amygdala in patients with autism has been documented using
fMRI with particular impairment noted in their ability to respond to facial
expressions of fear, to perceive eye-gaze direction and to establish recall
memory for faces. Other studies indicate that patients with either surgical or
congenital amygdala damage show similar symptoms. These data suggest that
reduced activity of the amygdala is important in autism.
About McLean Hospital
McLean Hospital maintains
the largest research program of any private, U.S. psychiatric hospital. It is
the largest psychiatric teaching facility of Harvard Medical School, an
affiliate of Massachusetts General Hospital and a member of Partners HealthCare
System. The Brain Imaging Center at McLean employs one of the largest MRI
instruments in the country in studies of brain function. Researchers at McLean
were part of the team that first identified regional abnormalities in brain
activation in patients with schizophrenia and in normal aging, as well as
regional changes in blood flow and metabolism in patients with Alzheimer's
disease.
About Repligen Corporation
Repligen Corporation
develops new drugs for debilitating pediatric disorders including autism,
cancer, and immune and metabolic disorders. Repligen also manufactures and
markets a set of patented products based on Protein A, which are used by the
pharmaceutical industry to produce therapeutic antibodies. Its corporate
headquarters are located at 117 Fourth Avenue, Needham MA, 02494. Additional
information may be requested from www.repligen.com.
This release contains
forward-looking statements which are made pursuant to the safe harbor
provisions of Section 21E of the Securities Exchange Act of 1934. The
forward-looking statements in this release do not constitute guarantees of
future performance. Invest ors are cautioned that statements in this press
release which are not strictly historical statements, including, without
limitation, statements regarding current or future financial performance,
management's strategy, plans and objectives for future operations, clinical
trials and results and product plans and performance, 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 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, 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.
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SOURCE Repligen Corporation
CONTACT: Walter C. Herlihy, Ph.D., President and Chief Executive Officer
of Repligen, +1-781-449-9560, ext. 2000; or investors, Isabel Cordova of The
Trout Group, +1-212-477-9007, ext. 13
URL:
http://www.repligen.com
Copyright (C) 2001 PR
Newswire. All rights reserved.
KEYWORD: Massachusetts
INDUSTRY KEYWORD: MTC HEA
Copyright © 2001, PR
Newswire, all rights reserved.
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