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 The leading web portal for pharmacy resources, news, education and careers April 28, 2017
Pharmacy Choice - Pharmaceutical News - AB Science announces positive top-line results of final analysis from study AB10015 of masitinib in amyotrophic lateral sclerosis (ALS) - April 28, 2017

Pharmacy News Article

 3/20/17 - AB Science announces positive top-line results of final analysis from study AB10015 of masitinib in amyotrophic lateral sclerosis (ALS)



                                                       Paris, 20 March 2017, 8am

     AB Science announces positive top-line results of final analysis from study
  AB10015 of masitinib in amyotrophic lateral sclerosis (ALS), also known as Lou
                                                                Gehrig's disease

                     Primary analysis is a success and confirms interim analysis

                                     Company to host webcast on masitinib in ALS

AB  Science SA  (NYSE Euronext  - FR0010557264  - AB),  a pharmaceutical company
specializing  in  the  research,  development  and  commercialization of protein
kinase  inhibitors (PKIs), today  announced that the  phase 2/3 study AB10015 of
masitinib  in  amyotrophic  lateral  sclerosis  (ALS)  has met its pre-specified
primary  endpoint.  This  is  the  first  successful phase 3 trial of a tyrosine
kinase inhibitor in the treatment of ALS, signifying masitinib as first-in-class
for ALS, with a unique mechanism of action against microglia cells.

A  webcast will be hosted on 20 March  2017 at 6 pm (CET). To participate please
email at linda.carlet@ab-science.com.

Study  AB10015 was a double-blind, placebo-controlled phase 2/3 study to compare
the  efficacy  and  safety  of  masitinib  in  combination with riluzole, versus
placebo in combination with riluzole in the treatment of patients suffering from
ALS.

In  accordance with  study protocol,  the final  analysis was performed based on
394 patients  treated  for  48-weeks  and  randomly allocated to three different
treatment  arms: masitinib  at 4.5 mg/kg/day,  versus masitinib  at 3 mg/kg/day,
versus placebo, each administered as an add-on to riluzole. The primary endpoint
was  based on  the change  from baseline  to week  48 in the revised Amyotrophic
Lateral  Sclerosis Functional Rating  Scale (ALSFRS-R). The  ALSFRS-R score is a
validated  rating  instrument  for  monitoring  the progression of disability in
patients  with  ALS,  which  correlates  significantly  with quality-of-life and
survival.   This   endpoint  is  recommended  by  EMA  and  FDA  guidelines  for
registration  in  ALS.  Also  consistent  with  EMA  guidance,  Progression Free
Survival  (PFS) was included as a  key secondary endpoint for registration, with
progression  being defined  as ALSFRS-R  deterioration of  more than 9 points or
death. A stepwise sequence of analysis was predefined to first test masitinib at
4.5 mg/kg/day versus placebo, and then masitinib at 3 mg/kg/day versus placebo.

For masitinib at 4.5 mg/kg/day:
  * Primary analysis on the change in ALSFRS-R score at week 48 (mLOCF
    methodology) is statistically significant with a P-value of 0.014.
  * Sensitivity tests on the primary analysis consisted in two models to impute
    a value at week 48 for any patients who discontinued treatment before week
    48. Those sensitivity analyses are also significant with a P-value of 0.020.
  * The key secondary analysis on PFS was statistically significant with a P-
    value of 0.016.
  * Quality-of-life measured by change in ALSAQ score was also statistically
    significant with a P-value<0.01.


For masitinib at 3 mg/kg/day:
  * There was a trend in favor of masitinib versus placebo for change in ALSFRS
    score at week 48 (LOCF methodology) and likewise for the two imputation
    models (sensitivity analyses) and in PFS (secondary analysis).
  * The change in quality-of-life was statistically significant (p-value<0.01)
    in favor of masitinib.


The  adverse events observed for masitinib in study AB10015 were consistent with
its  known safety profile. There were no  new safety events at final analysis as
compared with interim analysis.

The  final analysis confirms the interim analysis, which was performed with 50%
of patients.

AB  Science filed an application for marketing authorization of masitinib in ALS
at EMA in September 2016.
Full efficacy and safety data will be submitted for presentation at the European
Network for the Cure of ALS (ENCALS) annual meeting in Ljubljana, Slovenia (18 -
20 May, 2017).

Alain  Moussy,  CEO  of  AB  Science  said:  "This  is  a very good news for the
patients.  These final data  confirm findings from  the study's interim analysis
and  proves that  masitinib is  capable of  slowing down motoneuron degenerative
disease  such as  ALS, which  is a  devastating condition  with an  urgent unmet
medical need."

Professor   Olivier  Hermine,  President  of  AB  Science  scientific  committee
declared: "Perhaps the most impressive finding from this study is that masitinib
has generated a significant difference in progression free survival with respect
to   the   placebo   treatment-arm.  Similar  to  cancer  studies  when  PFS  is
significantly  improved, this  indicates a  clear clinical  benefit in  favor of
masitinib."

Dr.   Jess  Mora  Pardina,  international  coordinator  of  study  AB10015  and
neurologist  expert  in  ALS  declared:  "Masitinib  is  one  of  the rare drugs
developed  for  the  treatment  of  ALS  that  has  proved  its efficacy through
validated  endpoints. These results are truly  encouraging and can be considered
as a major breakthrough for ALS treatment, a condition that has proved extremely
challenging in the development of new effective medication. Masitinib may be the
long-awaited addition to the therapeutic armamentarium of ALS."

The  mechanism  of  action  of  masitinib  in  ALS  is based on the targeting of
neurotoxic   aberrant   glial   cells   via   CSF1R   inhibition,   providing  a
neuroprotective effect and slowing down neurodegeneration.

Amyotrophic  lateral sclerosis is  a rare degenerative  disorder that results in
progressive  wasting and paralysis of voluntary muscles. There are approximately
50,000 people  with ALS  in the  European Union  and in  the US,  with more than
16,000 new  cases diagnosed each year in Europe and in the US. Almost 80% of ALS
patients die within 5 years and 90% die within 10 years.

Masitinib received orphan drug designation for ALS from both EMA and FDA.

About masitinib
Masitinib  is a new  orally administered tyrosine  kinase inhibitor that targets
mast  cells and macrophages, important cells  for immunity, through inhibiting a
limited  number of kinases.  Based on its  unique mechanism of action, masitinib
can  be developed in a  large number of conditions  in oncology, in inflammatory
diseases, and in certain diseases of the central nervous system. In oncology due
to  its immunotherapy effect, masitinib can have an effect on survival, alone or
in  combination  with  chemotherapy.  Through  its  activity  on  mast cells and
microglia  and consequently the inhibition of the activation of the inflammatory
process,  masitinib  can  have  an  effect  on the symptoms associated with some
inflammatory  and central nervous system diseases  and the degeneration of these
diseases.

About AB Science
Founded  in 2001, AB  Science is  a pharmaceutical  company specializing  in the
research, development and commercialization of protein kinase inhibitors (PKIs),
a  class of targeted proteins whose action  are key in signaling pathways within
cells.  Our programs target  only diseases with  high unmet medical needs, often
lethal  with  short  term  survival  or  rare  or refractory to previous line of
treatment   in  cancers,  inflammatory  diseases,  and  central  nervous  system
diseases, both in humans and animal health.
AB  Science has developed a proprietary portfolio of molecules and the Company's
lead compound, masitinib, has already been registered for veterinary medicine in
Europe  and in  the USA.  The company  is currently  pursuing thirteen  phase 3
studies  in human medicine in  metastatic prostate cancer, metastatic pancreatic
cancer,  relapsing  metastatic  colorectal  cancer, relapsing metastatic ovarian
cancer,  GIST, metastatic  melanoma expressing  JM mutation  of c-Kit, relapsing
multiple  myeloma,  relapsing  T-cell  lymphoma,  mastocytosis,  severe  asthma,
amyotrophic  lateral  sclerosis,  Alzheimer's  disease  and progressive forms of
multiple sclerosis. The company is headquartered in Paris, France, and listed on
Euronext Paris (ticker: AB).

Further information is available on AB Science's website: www.ab-science.com.

Forward-looking Statements - AB Science
This press release contains forward-looking statements. These statements are not
historical  facts. These statements include projections and estimates as well as
the  assumptions  on  which  they  are  based,  statements  based  on  projects,
objectives,  intentions  and  expectations  regarding financial results, events,
operations,  future services, product development  and their potential or future
performance.

These  forward-looking statements can often be identified by the words "expect",
"anticipate", "believe", "intend", "estimate" or "plan" as well as other similar
terms.   While   AB   Science  believes  these  forward-looking  statements  are
reasonable,  investors are  cautioned that  these forward-looking statements are
subject  to numerous risks  and uncertainties that  are difficult to predict and
generally  beyond the control of AB Science and which may imply that results and
actual  events significantly differ from those expressed, induced or anticipated
in the forward-looking information and statements. These risks and uncertainties
include  the uncertainties related  to product development  of the Company which
may  not be successful  or to the  marketing authorizations granted by competent
authorities  or, more generally, any factors  that may affect marketing capacity
of  the  products  developed  by  AB  Science,  as  well  as  those developed or
identified  in the public  documents filed by  AB Science with  the Autorit des
Marchs Financiers (AMF), including those listed in the Chapter 4 "Risk Factors"
of  AB Science reference document filed with the AMF on November 22, 2016, under
the  number  R.  16-078. AB  Science  disclaims any obligationor undertaking to
update the forward-looking information and statements, subject to the applicable
regulations,   in   particular   articles  223-1 et  seq.  of  the  AMF  General
Regulations.

For additional information, please contact:

AB Science
Financial Communication & Media Relations
investors@ab-science.com

CPEng: 
http://hugin.info/155655/R/2088878/788537.pdf



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
    
Source: AB Science via GlobeNewswire

 
  



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