Schering AG, Germany Announces Results of Two Clinical Trials With Sargramostim in Crohn's Disease Patients
31 Juli 2006 - 4:36PM
PR Newswire (US)
Induction Trial (n.o.v.e.l. 4) did not Meet Primary Endpoint
BERLIN, Germany, July 31 /PRNewswire-FirstCall/ -- Schering AG,
Germany (FSE: SCH, NYSE: SHR) today announced results observed in
two recently completed placebo-controlled, randomized, double-blind
clinical studies of sargramostim for the treatment of Crohn's
disease. Results from the Phase III induction trial (n.o.v.e.l. 4)
suggest a treatment benefit but fail to demonstrate superiority in
the two primary endpoints of response and/or remission at eight
weeks compared to placebo. However, primary and secondary endpoints
were met in the n.o.v.e.l. 2 study. This Phase II trial
demonstrated that sargramostim was significantly more effective
than placebo for induction of corticosteroid-free clinical
remission in steroid-dependent Crohn's disease patients. "While we
are disappointed that the n.o.v.e.l. 4 trial results did not uphold
the significant outcomes observed in the Phase II induction trial
(n.o.v.e.l. 1), the data did trend toward a treatment benefit with
sargramostim," said Prof. Marc Rubin, member of the Executive Board
of Schering AG, responsible for Development and Specialized
Therapeutics. "We are pleased that n.o.v.e.l. 2 did achieve a
positive primary endpoint of steroid-free clinical remission. This
study is the first randomized, double-blind, placebo-controlled
trial conducted with any biological therapy in active
steroid-dependent Crohn's disease patients." Rubin further said
that at this time the development program continues to move
forward. Schering AG is conducting an in-depth analysis of the data
and will be in contact with regulatory agencies to discuss any
potential adjustments to the development program in order to make
sargramostim available for Crohn's disease patients. The trials are
part of a comprehensive, worldwide clinical trials program
(n.o.v.e.l.(TM) - new opportunities to verify evolving logic in
Crohn's disease) supported by Schering AG, Germany for the ongoing
evaluation of sargramostim as an entirely new approach to the
treatment of Crohn's disease. Crohn's disease is a chronic
gastrointestinal inflammatory disease, diagnosed in more than one
million patients worldwide, for which there is currently no cure
and for which therapy is often needed on a long-term basis. The
Studies N.o.v.e.l. 4 was a Phase III multi-center, randomized,
double-blind, placebo-controlled study to evaluate the induction of
response and remission in patients with moderately-to-severely
active Crohn's disease. In this study, 288 patients were randomized
in nine countries. Patients received 6 microg/kg/day sargramostim
or placebo via subcutaneous injection for eight weeks. Efficacy was
based on the Crohn's Disease Activity Index (CDAI), the standard
measure of treatment effectiveness based on an analysis of several
variables assessed by patients and physicians. Response was defined
as a CDAI decrease of at least 100 points and remission was defined
as a CDAI score of 150 points or below. The results in this study
were achieved without the use of steroids and/or
immunosuppressants. N.o.v.e.l. 2 was a multi-center, randomized,
double-blind, placebo-controlled study conducted in the U.S. and
Canada in 129 patients with active corticosteroid-dependent Crohn's
disease requiring 10-40 mg of prednisone or equivalent. Patients
received 6 microg/kg/day sargramostim or placebo via subcutaneous
injection. Treatment duration was between 12 to 22 weeks depending
on the baseline corticosteroid dose. The primary efficacy endpoint
was corticosteroid-free clinical remission (CDAI less than or equal
to 150) four weeks after complete corticosteroid withdrawal. About
Sargramostim Sargramostim is a man-made form of a naturally
occurring growth factor. In the United States, sargramostim is
marketed as LEUKINE(R) by Berlex, Inc., a U.S. affiliate of
Schering AG, Germany, and has been administered to more than
300,000 patients, most of whom are suffering from acute myelogenous
leukemia (AML). This drug is the only growth factor approved in the
United States for use following induction chemotherapy in older
adults with AML to shorten the time to neutrophil recovery and
reduce the incidence of severe and life-threatening infections and
infections resulting in death. It has also been approved in the
United States for use in four additional indications: myeloid
reconstitution following allogeneic and autologous bone marrow
transplantation (BMT), peripheral blood stem cell (PBSC)
mobilization and subsequent myeloid reconstitution in patients
undergoing PBSC transplantation, and bone marrow transplantation
failure or engraftment delay. Schering AG is a research-based
pharmaceutical company. Its activities are focused on four business
areas: Gynecology&Andrology, Oncology, Diagnostic Imaging as
well as Specialized Therapeutics for disabling diseases. As a
global player with innovative products, Schering AG aims for
leading positions in specialized markets worldwide. With in-house
R&D and supported by an excellent global network of external
partners, Schering AG is securing a promising product pipeline.
Using new ideas, Schering AG aims to make a recognized contribution
to medical progress and strives to improve the quality of life:
making medicine work This press release has been published by
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contacts at Corporate Communication: Media Relations: Oliver
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Reinhard, T: +49-30-468-150-62, Pharma Communication: Dr Claudia
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