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Studies showed superiority on primary and major secondary endpoints
in people with relapsing forms of multiple sclerosis
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Genentech will submit data to the U.S. Food and Drug Administration
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Phase III study in primary progressive multiple sclerosis ongoing
Company Website:
http://www.gene.com
SOUTH SAN FRANCISCO, Calif. -- (Business Wire)
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced positive results from two pivotal studies evaluating the
investigational medicine ocrelizumab compared with interferon beta-1a
(Rebif®), a standard-of-care therapy, in people with relapsing multiple
sclerosis (MS), the most common form of the disease. The studies (called
OPERA I and OPERA II) met their primary and major secondary endpoints.
Treatment with ocrelizumab significantly reduced the annualized relapse
rate (ARR) over a two-year period compared with interferon beta-1a, the
primary endpoint in both studies. Ocrelizumab also significantly reduced
the progression of clinical disability compared with interferon beta-1a,
as measured by the Expanded Disability Status Scale (EDSS).
Additionally, treatment with ocrelizumab led to a significant reduction
in the number of lesions in the brain (areas of disease activity)
compared with interferon beta-1a, as measured by MRI.
Overall, the incidence of adverse events associated with ocrelizumab was
similar to interferon beta-1a in both studies; the most common adverse
events were mild-to-moderate infusion-related reactions. The incidence
of serious adverse events associated with ocrelizumab, including serious
infections, was also similar to interferon beta-1a.
“Ocrelizumab showed remarkable improvements over a standard-of-care
medicine across clinical and imaging endpoints in two pivotal
studies,” said Sandra Horning, M.D., chief medical officer and head of
Global Product Development. “Ocrelizumab has the potential to make a
meaningful difference for people with MS, a chronic and debilitating
disease. Based on these compelling results, we plan to submit the data
for review to U.S. and EU regulatory authorities in the first quarter of
2016.”
Further analyses of the OPERA studies are ongoing and detailed data will
be presented at an upcoming medical congress.
Results from a Phase III study of ocrelizumab in people with primary
progressive MS (PPMS), a different form of MS, are expected later this
year.
About the OPERA Studies
OPERA I and OPERA II are Phase III, randomized, double-blind,
double-dummy, global multi-center studies evaluating the efficacy and
safety of ocrelizumab (600 mg dose administered by intravenous infusion
every six months) compared with interferon beta-1a (44 mcg dose
administered by subcutaneous injection three times per week) in people
with relapsing forms of MS.1 The primary endpoint of the
OPERA studies was annualized protocol-defined relapse rate (ARR) at two
years (96 weeks). Secondary endpoints included time to onset of
confirmed disability progression, the total number of T1
Gadolinium-enhancing lesions, and total number of new and/or enlarging
T2 hyperintense lesions as detected by brain MRI.
The OPERA I and OPERA II studies enrolled a total of 1,656 people with
relapsing forms of MS (i.e., relapsing-remitting MS and
secondary-progressive MS with relapses) across 307 sites in 40 countries.
About ocrelizumab
Ocrelizumab is an investigational, humanized monoclonal antibody
designed to selectively target CD20-positive B cells. CD20-positive B
cells are a specific type of immune cell thought to be a key contributor
to myelin (nerve cell insulation and support) and axonal (nerve cell)
damage, which can result in disability in people with MS. Ocrelizumab
binds to CD20 cell surface proteins expressed on certain B cells, but
not on stem cells or plasma cells. Therefore the ability to make new B
cells is preserved in people treated with ocrelizumab.
The Phase III clinical development program for ocrelizumab includes the
OPERA I and OPERA II studies in people with relapsing forms of MS, as
well as ORATORIO, a randomized, double-blind, global multi-center,
placebo-controlled study in people with PPMS.2
About Genentech in Neuroscience
Neuroscience is a major focus of research and development at Genentech
and Roche. The company’s goal is to develop treatment options based on
the biology of the nervous system to help improve the lives of people
with chronic and potentially devastating diseases. Our neuroscience
research and development program includes more than a dozen
investigational medicines in clinical development for diseases that
include multiple sclerosis, Alzheimer’s disease, spinal muscular
atrophy, Parkinson’s disease, Down syndrome and autism.
About Genentech
Founded more than 35 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious or life-threatening medical
conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.
All trademarks used or mentioned in this release are protected by law.
Rebif is a registered trademark of Merck KGaA and EMD Serono, Inc.
References
1 F. Hoffmann-La Roche. ClinicalTrials.gov NCT01247324 and
NCT01412333. National Library of Medicine. Available at: https://clinicaltrials.gov/ct2/show/NCT01247324
and https://clinicaltrials.gov/ct2/show/NCT01412333.
2 F. Hoffmann-La Roche. ClinicalTrials.gov NCT01194570.
National Library of Medicine. Available at: https://clinicaltrials.gov/ct2/show/NCT01194570.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150629006372/en/
Contacts:
Genentech
Media Contact:
Tara Iannuccillo, 650-467-6800
Investor
Contacts:
Stefan Foser, 650-467-2016
Karl Mahler, 011 41 61
687 8503
Source: Genentech
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