Follow-on Study Planned to Target a Cognitive Deficit of Schizophrenia
WALTHAM, Mass., Feb. 4 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported initial results for a Phase 2 clinical trial of
secretin in refractory schizophrenia. The analysis indicates that secretin
did not produce a statistically significant improvement in patient symptoms as
measured by the Clinical Global Impression (CGI) or the Positive And Negative
Syndrome Scale (PANSS). There were no serious adverse events in the trial.
The Phase 2 trial evaluated 4 intravenous doses of secretin vs. a placebo
over two weeks. Patients were assessed at baseline and six times during the
treatment period with several psychometric instruments including the CGI and
the PANSS. There were a total of 44 evaluable patients who received either
placebo (n=15), secretin at 2 CU/kg (n=15) or secretin at 5 CU/kg (n=14). The
mean change in CGI in the secretin group was not significantly different than
placebo. In a responder analysis, a CGI responder was defined as a rating of
"Very Much Improved" or "Much Improved" in at least four of the six
evaluations during the treatment period. There were 2 responders (13%) in the
placebo group, 3 responders (20%) in the low dose secretin group and 4
responders (29%) in the high dose group; however, this trend was not
significant given the low power of this study.
There was not a significant treatment effect documented with the PANSS
positive symptom sub-scale or the PANSS negative symptom sub-scale. In
addition to positive and negative symptoms, the PANSS items were also analyzed
for dysphoric mood, activation/aggression and autistic preoccupation. There
was a trend towards improvement on the dysphoric mood scale (anxiety, tension,
etc.) in the secretin group (P=0.06).
Several clinical investigators reported transient changes in the social
interaction of patients at the time of the infusion. We intend to gather
additional observations from the sites prior to unblinding site personnel to
better understand these observations. In addition, several patients
participated in a cognitive testing paradigm within two hours of the first
dose to assess the impact of secretin on one of the cognitive deficits
characteristic of patients with schizophrenia. The results suggest that
further investigation of this symptom is warranted. We are currently
discussing the design of a follow-up study to determine if this observation is
reproducible and related to drug treatment.
The Phase 2 study was designed to confirm the results of a Phase 1 trial
of secretin in schizophrenia which was carried out independently by
investigators at the University of North Carolina. In that study, 22 patients
with refractory schizophrenia received either a single, intravenous dose of 1
or 2 CU/kg of secretin or a placebo. Several patients in the secretin group
had marked, but transient improvements in symptoms compared to none in the
placebo group. The secretin group was significantly more improved than the
placebo group as judged by Clinical Global Impression scores at 3 and 7 days
after treatment. In a CGI responder analysis, 3 of 11 patients (27%) in the
secretin group were rated as responders compared to none in the placebo group.
No differences between the groups were observed in the PANSS evaluation one
week after treatment.
About Schizophrenia
Schizophrenia is a serious and chronic neuropsychiatric disorder that
affects 2 million people in the United States. The pathology of schizophrenia
is marked by 1) "positive" symptoms such as hallucinations and disorganized
speech, 2) "negative" symptoms such as lack of initiative and social
withdrawal, 3) alterations in mood such as anxiety and depression, 4) deficits
in general cognition including the inability to learn and reason and 5)
deficits in social cognition including the processes we use to understand the
world around us. Deficits in cognition are present at all stages of the
disease, contribute to the rate of relapse and are predictive of long-term
outcome. Current treatment with antipsychotic therapy is generally directed
at control of positive symptoms. Even when successful, antipsychotic therapy
has limited impact on negative symptoms and severe residual and incapacitating
social and emotional deficits may persist. Sales of antipsychotic drugs for
schizophrenia including Zyprexa(TM), Risperdal(TM) and Geodon(TM) totaled
approximately $5 billion in the United States in 2002. The total cost for the
care and treatment of patients with schizophrenia in the United States in 2000
was approximately $40 billion.
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 with particular emphasis on applications for
children. Repligen has a Specialty Pharmaceuticals business comprised of
rProtein A(TM) and SecreFlo(TM), 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 obtained 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.
CONTACT:
Walter C. Herlihy, Ph.D.
President and Chief Executive Officer
(781) 250-0111, ext. 2000
Laura Whitehouse
Vice President, Market Development
(781) 250-0111, ext. 2306
SOURCE Repligen Corporation
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Related links:
http://www.repligen.com
CONTACT:
Walter C. Herlihy, Ph.D., President and Chief
Executive Officer, +1-781-250-0111, ext. 2000, or Laura
Whitehouse, Vice President, Market Development, +1-781-250-0111,
ext. 2306 both of Repligen
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