DIR Return Create A Forum - Home
---------------------------------------------------------
MS Speaks
HTML https://msspeaks.createaforum.com
---------------------------------------------------------
*****************************************************
DIR Return to: ZEPOSIA (ozanimod)
*****************************************************
#Post#: 1293--------------------------------------------------
Ozanimod from Celgene may be added to the MS drugs
By: agate Date: July 16, 2016, 9:07 pm
---------------------------------------------------------
This article in Multiple Sclerosis News Today (February 24)
indicates that another MS drug, ozanimod, may be coming along
soon.
A couple of financial Websites suggest that this drug is quite
similar to one about to be marketed by Biogen.
HTML http://multiplesclerosisnewstoday.com/2016/02/24/relapsing-ms-treatment-showing-efficacy-phase-2-extension-study-celgene-reports-actrims-2016/
HTML http://multiplesclerosisnewstoday.com/2016/02/24/relapsing-ms-treatment-showing-efficacy-phase-2-extension-study-celgene-reports-actrims-2016/
#Post#: 1570--------------------------------------------------
Re: Ozanimod from Celgene may be added to the MS drugs
By: agate Date: February 22, 2017, 11:56 am
---------------------------------------------------------
From MedPage Today, February 21, 2017:
[quote]SAVE
SAVED
by Kristina Fiore
Associate Editor, MedPage Today
February 21, 2017
Celgene said its S1P receptor modulator for relapsing MS met the
primary endpoint in the SUNBEAM study of reducing annualized
relapse rate compared with weekly interferon over a year.
Patients on ozanimod also did better on secondary endpoints of
reduced gadolinium-enhancing lesions and number of new or
enlarging T2 lesions at that time point. Confirmatory data are
expected from the phase III RADIANCE trial at the end of the
second quarter this year. The goal of second-generation S1P
drugs is to reduce the cardiac monitoring requirement seen with
the first-generation drug fingolimod (Gilenya).[/quote]
#Post#: 1662--------------------------------------------------
(AAN) Placebo patients switched to ozanimod catch up in lowerin
g relapse rate
By: agate Date: May 2, 2017, 12:06 am
---------------------------------------------------------
From MedPage Today, April 27, 2017:
[quote]Ozanimod Keeps on Working in MS Extension Trial
Placebo patients switched to the investigative agent catch up in
lowering relapse rate
by Florenz Turkel
Contributing Writer, MedPage Today
When patients diagnosed with multiple sclerosis are switched
from placebo in clinical trials to the investigative agent
ozanimod, the annualized relapse rate falls to levels similar to
those achieved by patients who have been on the new drug
throughout the trial, researchers reported.
In the core RADIANCE (part 1) trial, patients assigned to
placebo experienced a 0.57 rate of relapses in the first 24
weeks, but once they were switched to ozanimod that rate fell to
0.31 on the 0.5 mg dose of ozanimod and to a rate of 0.27 if
they were treated with the 1 mg dose of ozanimod, reported
Jeffrey Cohen, MD, director of experimental neurotherapeutics at
the Mellon Center for MS Treatment and Research at the Cleveland
Clinic in Ohio.
That compared with a rate of 0.25 for patients who were
originally assigned to ozanimod 0.5 mg at the start of the study
and to a rate of 0.15 relapses a year among the patients who
were started on ozanimod 1 mg at the beginning of the trial. The
original trial and its extension are double-blinded.
After 2 years on the drug, there were little differences in
relapse rates among those who started on ozanimod 0.5 mg and the
original placebo patients switched to the lower dose – a rate of
0.35 for the patients switched to ozanimod and a rate of 0.38
for those who had been on ozanimod for the 24-week treatment
part of the trial, Cohen reported at the annual meeting of the
American Academy of Neurology.
The story was the same for patients treated with 1 mg of
ozanimod – those who were switched from placebo had an
annualized relapse rate of 0.12 compared with an annualized
relapse rate of 0.15 for the patients who were on ozanimod from
the get-go at the 2 year milestone.
"Both ozanimod 0.5 mg and 1 mg demonstrated continued efficacy
on MRI and clinical measurements of multiple sclerosis disease
activity over 2.5 years," Cohen said in his oral platform
presentation.
The researchers included 82 patients in the extension trial who
were originally on placebo. They were assigned to either the 0.5
mg or the 1 mg dose of ozanimod – 41 patients in each group.
They joined 84 patients who had been on ozanimod 0.5 mg at
baseline and 81 patients who had been on ozanimod 1 mg from the
start of the RADIANCE study.
Cohen said that the extension trial did not come with any
surprises in the context of adverse events. "No new
treatment-emergent adverse events associated with ozanimod over
the 2 years or more treatment were observed," Cohen said. He
said there were no new adverse effects seen by dose of the
agent.
He did note that 5 patients who were found to have increased
liver enzymes 5 times the upper limits of normal were taken off
the drug. Ozanimod is a sphingosine-1-phosphate (S1P) receptor
agonist. Phase III trials, including RADIANCE (part 2) are
underway, Cohen said at the annual meeting of the American
Academy of Neurology. Ozanimod specifically targets two of the
five S1P sites, making it more selective that fingolimod
(Gilenya).
The patients in the study were about 38 years old and 70% were
women; more than 98% were white. They had been diagnosed with
multiple sclerosis for about 3.8 years. The average number of
relapses per year at baseline was 2. About 25% of the patients
had previously been on prior medication for multiple sclerosis.
After a 30-day screening protocol, patients were given a 7-day
period to escalate the oral dose to either 0.5 mg or 1 mg or
placebo, and then took their assigned pills for 24 weeks. After
that period, the patients on placebo were reassigned to either
dose of the drug.
"The key as to where ozanimod will fit into clinical practice
will depend on the safety profile," said Jennifer Graves, MD,
assistant professor of neurology and ophthalmology at the
University of California, San Francisco.
"The efficacy looks similar to other drugs in the field. So if
there are fewer adverse events that could determine how the drug
will fit in the marketplace," Graves, co-moderator of the
session, told MedPage Today.
______________________
The trial was supported by Receptos, a subsidiary of Celgene,
Inc.
Cohen disclosed relevant relationships with Merck, Novartis, and
Receptos.
Graves disclosed relevant relationships with Genentech, Biogen,
and S3 Group.[/quote]
#Post#: 1865--------------------------------------------------
(ECTRIMS 2017) Ozanimod shows promise in MS
By: agate Date: October 30, 2017, 8:02 pm
---------------------------------------------------------
From MedPage Today, October 30, 2017:
"Next-gen S1P receptor modulator [ozanimod] shows promise in MS"
HTML https://www.medpagetoday.com/MeetingCoverage/ECTRIMS/68876?xid=nl_mpt_special_reports_2017-10-30%20&uun=g345846d0r5339616u
#Post#: 1911--------------------------------------------------
Ozanimod successful in clinical trials
By: agate Date: December 7, 2017, 1:16 am
---------------------------------------------------------
From Science Daily (November 9, 2017):
:"MS:
Ozanimod successful in clinical trials"
HTML https://www.sciencedaily.com/releases/2017/11/171109224027.htm
*****************************************************