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#Post#: 947--------------------------------------------------
(MSAA) Ocrelizumab shows positive results in treating PPMS
By: agate Date: September 28, 2015, 7:43 pm
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From the MSAA newsletter, September 28, 2015:
[quote]Ocrelizumab Shows Positive Results in Treating PPMS
Parent company Genentech announced today that ocrelizumab, an
investigational medicine for the long-term treatment of
relapsing forms of MS, has also shown positive study results in
their Phase III ORATORIO study with primary-progressive multiple
sclerosis (PPMS). This is the first medication to show positive
effects on disability with this form of the disease, which
affects approximately 10 percent of the MS population.
To date, 13 disease-modifying therapies (DMTs) are approved for
the long-term treatment of relapsing forms of MS, which exhibit
the flare-ups and remissions often seen in MS. However, no
treatments are available for individuals diagnosed with PPMS,
whose MS steadily progresses without remissions.
According to Genentech, the Phase III ORATORIO study met its
primary endpoint, showing that treatment with ocrelizumab
significantly reduced the progression of clinical disability
sustained for at least 12 weeks compared with placebo, as
measured by the Expanded Disability Status Scale (EDSS). They
also state that overall, the incidence of adverse events
associated with ocrelizumab was similar to placebo; 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 placebo.
ORATORIO was a randomized, double-blind, and global multi-center
trial that studied the effectiveness and safety of ocrelizumab
in 732 people with PPMS. Every six months, two 300-mg infusions
(for a total of 600 mgs) were given two weeks apart. Members of
the treatment group were compared to a placebo group. The
primary endpoint of this study was time to the onset of
confirmed disability progression, defined as an increase in EDSS
that is sustained for at least 12 weeks.
On July 1, 2015, MSAA posted the news item titled Ocrelizumab
Shows Positive Results in Phase III Trials, which announced that
ocrelizumab met both the primary and major secondary endpoints
in the Phase III, OPERA I and OPERA II studies. These studies
evaluated the effectiveness and safety of ocrelizumab in
relapsing forms of MS. According to Genentech, when compared to
Rebif, ocrelizumab showed "significant reductions" in:
annualized relapse rate (ARR) over a two-year period;
progression of clinical disability, as measured by the Expanded
Disability Status Scale (EDSS); and number of lesions in the
brain (areas of disease activity) as measured by MRI.
Ocrelizumab is an investigational, humanized monoclonal antibody
designed to selectively target CD20-positive B cells. Genentech
notes that these are a specific type of immune cell thought to
be a key contributor to myelin and axonal damage, which can
result in disability in people with MS. Based on preclinical
studies, ocrelizumab binds to CD20 cell surface proteins
expressed on certain B cells, but not on stem cells or plasma
cells, and therefore important functions of the immune system
may be preserved.
Genentech plans to submit data from all three of these studies
to the United States Food and Drug Administration (FDA) in early
2016. If approved, this medication could potentially be used to
treat not only relapsing forms of MS, but also
primary-progressive MS, and would represent the first treatment
available for this latter form of the disease.
MSAA Chief Medical Officer Dr. Jack Burks states, "This is very
exciting news. Ocrelizumab is the first DMT with positive
disability results. In addition, the safety data were similar to
placebo controls. However, FDA approval will require intense
scrutiny of these data. Effectiveness combined with safety is
the magic formula, and we’ll see if the FDA agrees that
ocrelizumab meets both requirements for approval in not only
relapsing forms of MS, but in PPMS as well."
_______________________
Written by Susan Wells Courtney, MSAA Senior Writer and Creative
Director
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer[/quote]
#Post#: 1007--------------------------------------------------
Roche to pursue Ocrelizumab drug market authorization
By: agate Date: November 18, 2015, 12:51 am
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From Multiple Sclerosis News Today, November 16, 2015:
[quote]Roche to Pursue MS Ocrelizumab Drug Market Authorization
Data on PPMS and RMS groundbreaking therapy ocrelizumab will be
submitted to global regulatory authorities
Patricia Silva, PhD
Roche recently provided an update on their late-stage pipeline
products across several therap-eutic areas, including
ocrelizumab for the treatment of multiple sclerosis. The data
was disclosed on Nov. 5 at the Roche Pharma Day 2015 event in
London, U.K.
Ocrelizumab was previously revealed to be the first
investigational medicine to have a positive impact in two forms
of multiple sclerosis, primary progressive multiple sclerosis
(PPMS) and relapsing multiple sclerosis (RMS). Ocrelizumab is a
recombinant humanized monoclonal antibody against immune B cells
that express CD20 proteins at their surface. These cells are
thought to be a key contributor to the myelin and neuron damage
that leads to motor function impairment, irreversible
neurological disability, and paralysis in multiple sclerosis
patients. Roche is planning to submit data on ocrelizumab to
global regulatory authorities in early 2016 to obtain marketing
authorization for the drug as a potential new therapy for RMS
and a first approved treatment for PPMS.
Apart from the update on the company’s most advanced
investigational therapeutics presented at the event, executives
also briefed investors and analysts on Roche’s strategy, R&D
productivity, management and new market opportunities. Roche’s
strategy is to continue to focus on innovation and treatment
advancement across a range of high medical need areas. The
company plans to further explore the wealth of molecular data
becoming available and use that information in drug discovery
and development.
“Thanks to our diversified late-stage portfolio we are well
positioned to maintain our leadership in oncology, expand
further in the immunology and ophthalmology segments, and
potentially offer new treatments to help improve the lives of
people with multiple sclerosis and haemophilia,” said Daniel
O’Day, COO of Roche’s Pharmaceuticals Division in a news
release. “And we are looking to harness the vast increase in
molecular information as the next important step in our efforts
to develop even better, more personalized treatment
solutions.”[/quote]
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