Ceregene Receives Additional Grant From Michael J. Fox Foundation to Expand Long-Term Testing of CERE-120 Patients
05 Agosto 2009 - 10:00AM
PR Newswire (US)
SAN DIEGO, Aug. 5 /PRNewswire/ -- Ceregene, Inc. today announced
that the Michael J. Fox Foundation will provide partial funds for
long-term follow-up testing of patients enrolled in the company's
Phase 2 trial of CERE-120 for Parkinson's disease. The funding will
enable Ceregene to collect and analyze more extensive data for up
to 48 months from patients with advanced Parkinson's disease who
were enrolled in the double-blind, controlled trial which ended in
November 2008. As was previously announced, the Phase 2 trial of
CERE-120 involving 52 patients, failed to demonstrate a difference
in the primary endpoint between patients in the CERE-120 versus
control group. It was subsequently announced, however, that
CERE-120 suggested improvement on several secondary endpoints at 12
months, and at 18 months, a statistically significant treatment
effect on the primary endpoint emerged, while several additional
secondary endpoints also showed improvement. In contrast, on no
measure did sham patients perform better than CERE-120 patients, at
either 12 or 18 months. Based on those findings, and insight gained
from analyses of post-mortem brain tissue from two CERE-120 treated
patients, the company has revised the dosing regimen and expects to
initiate a new trial of CERE-120 in the near future. "We are
pleased to be able to gather unique, long-term data from both
CERE-120 treated and control patients and thus gain more
information about the potential long-term effects of CERE-120 on
Parkinson's disease," stated Raymond T. Bartus, Ph.D., Ceregene's
executive vice president and chief scientific officer. "We very
much appreciate the support the MJFF has provided to enable us to
expand the testing of these patients and further enrich our data
base. Our conviction about CERE-120's potential to treat
Parkinson's disease remains strong. We learned a significant amount
from the initial Phase 2 trial which enabled us to design a
protocol that should maximize the potential for the greatest
treatment effect in our upcoming Phase 2 trial." About Phase 2
Trial of CERE-120 Ceregene's Phase 2 trial was a double-blind,
controlled clinical trial that completed enrollment of 58 patients
with advanced Parkinson's disease in October 2007. Patients in the
Phase 2 trial were enrolled across nine leading academic medical
centers in the United States, with two thirds of patients receiving
CERE-120 and one third enrolled into a control group. Patients
received a single administration of CERE-120 via stereotactic
neurosurgery to deliver the drug into the putamen region of the
brain and were followed for a minimum of 12 months for safety and
efficacy, with over half the subjects followed for 15 to 18 months
under blinded conditions, allowing longer-term analyses of the
therapeutic effects of CERE-120. About CERE-120 and its Application
to Treating Parkinson's Disease CERE-120 is composed of an
adeno-associated virus (AAV) vector carrying the gene for
neurturin, a naturally occurring protein known to repair damaged
and dying dopamine-secreting neurons, keeping them alive and
restoring normal function. Neurturin is a member of the same
protein family as glial cell-derived neurotrophic factor (GDNF).
The two molecules have similar pharmacological properties, and both
have been shown to benefit the midbrain dopamine neurons that
degenerate in Parkinson's disease. Degeneration of these neurons is
responsible for the major motor impairments of Parkinson's disease.
CERE-120 has been delivered by stereotactic injection to the
terminal fields (i.e., the ends of the degenerating neurons),
located in an area of the brain called the putamen. The cell bodies
for these same neurons are located in a different area of the
brain, called the substantia nigra. Once CERE-120 is delivered to
the brain, it provides stable, long-lasting expression of neurturin
in a highly targeted fashion. Genzyme Corporation (NASDAQ:GENZ) has
licensed the ex-North American rights for the development and
commercialization of CERE-120 from Ceregene, an agreement that was
announced in June 2007. About Parkinson's Disease Parkinson's
disease is a progressive movement disorder that affects a million
people in the United States. Its main symptoms, stiffness, tremors
and slowed movements and gait, are caused by a loss of
dopamine-containing nerve cells in the substantia nigra, which
project their axons to the putamen. Dopamine is a neurotransmitter
involved in controlling movement and coordination, so Parkinson's
patients exhibit a progressive inability to initiate and control
physical movements. There is currently no treatment that can
reverse the degeneration of these neurons, let alone cure
Parkinson's disease. About The Michael J. Fox Foundation The
Michael J. Fox Foundation is dedicated to ensuring the development
of better treatments, and ultimately a cure, for Parkinson's
disease through an aggressively funded research agenda. MJFF has
funded $149 million in research to date. About Ceregene Ceregene,
Inc. is a San Diego-based biotechnology company focused on the
delivery of nervous system growth (neurotrophic) factors for the
treatment of neurodegenerative and retinal disorders using gene
delivery. Ceregene's clinical programs include CERE-110, an AAV2
based vector expressing nerve growth factor that is currently in a
multi-center, controlled Phase 2 study for the treatment of
Alzheimer's disease, and CERE-120 (AAV2-Neurturin) for Parkinson's
disease. CERE-135 and CERE-140 are in preclinical development for
ALS (Lou Gehrig's disease) and ocular disorders, respectively.
Ceregene was launched in January 2001. The company's investors
include Alta Partners, MPM Capital, Investor Growth Capital and
Cell Genesys, Inc. (NASDAQ:CEGE) as well as Hamilton BioVentures
and California Technology Partners. DATASOURCE: Ceregene, Inc.
CONTACT: Jeffrey M. Ostrove, Ph.D., President and CEO of Ceregene,
Inc., +1-858-458-8808 Web Site: http://www.ceregene.com/
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