AB Science: The Data and Safety Monitoring Board Recommends the Continuation of Phase 3 Study of Masitinib in Amyotrophic Lat...
January 13 2015 - 11:48AM
AB Science SA (NYSE Euronext - FR0010557264 - AB), a
pharmaceutical company specialized in research, development and
marketing of protein kinase inhibitors (PKIs), announces that the
external Data and Safety Monitoring Board (DSMB) has recommended
the continuation of its phase 3 study of masitinib in amyotrophic
lateral sclerosis (ALS) based upon review of the latest safety
data. The DSMB was created as part of the Company's pivotal
clinical study evaluating masitinib in the treatment of amyotrophic
lateral sclerosis.
The on-going phase 3 clinical trial is an
international, multicenter, randomized, double-blind study
comparing the efficacy and safety of masitinib with that of placebo
in the treatment of patients with amyotrophic lateral sclerosis.
Study treatment is given as add-on therapy to patients who have
been treated with a stable dose of riluzole. The efficacy analysis
is measured by the Amyotrophic Lateral Sclerosis Functional Rating
Scale (ALSFRS-Revised) after 48 weeks of treatment.
These results are reassuring because they
confirm there are no observed safety concerns with masitinib in
combination with riluzole over a 1-year treatment period.
Professor Olivier Hermine, president of the
scientific committee of AB Science explained: "In this study, we
assume that mast cells, which are key immune cells, actively
participate to the pathogenesis of ALS, through the release of
mediators that sustain the inflammatory network of the central
nervous system. Mast cells, which are present in large quantities
in the brain and in the spinal cord, could also influence the
survival and function of motor neurons, and thus participate to the
pathophysiology of ALS. Since masitinib is a selective inhibitor of
c-Kit and Lyn, two kinases that play a major role in the survival
and activation of mast cells, it may lead to positive effects on
the symptoms of the pathology."
Dr. Luis Barbeito (Institut Pasteur de
Montevideo - Uruguay) commented: "We completed several studies in
animal models suggesting that masitinib might offer therapeutic
benefits in ALS patients alone or in combination with riluzole.
Notably, masitinib demonstrated in transgenic ALS murine model a
delay in the onset of symptoms, improvement in grip strength,
reduction in weight loss and a trend of increased survival.
Masitinib also prevented the increase in tryptase expression - a
marker of inflammation, and perivascular mast cell number, and
prevented motoneuron pathology and death in a murine model for ALS,
thus suggesting the implication of mast cells. We are currently
conducting additional animal experiments to better elucidate the
precise mechanism of action of masitinib in this disease, yet we
believe the body of evidence we already have strongly supports the
on-going phase 3 study in ALS."
Amyotrophic lateral sclerosis is a rare
degenerative disorder that results in progressive wasting and
paralysis of voluntary muscles. There are approximately 30,000
people with ALS in the European Union and 15,000 in the US, with
more than 7,500 new cases cases diagnosed each year in Europe and
4,500 in the US. Almost 50% of ALS patients die within 3 years and
90% die within 5 years.
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 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
first-line and second-line GIST, metastatic melanoma expressing JM
mutation of c-Kit, multiple myeloma, metastatic colorectal cancer,
metastatic prostate cancer, pancreatic cancer, mastocytosis, severe
persistent asthma, rheumatoid arthritis, Alzheimer's disease,
progressive forms of multiple sclerosis, and Amyotrophic Lateral
Sclerosis. The company is headquartered in Paris, France, and
listed on Euronext Paris (ticker: AB).
Further information is available on AB Science
website: www.ab-science.com.
This document contains prospective information.
No guarantee can be given as for the realization of these
forecasts, which are subject to those risks described in documents
deposited by the Company to the Authority of the financial markets,
including trends of the economic conjuncture, the financial markets
and the markets on which AB Science is present. *
* *
AB Science - Financial Communication & Media
Relations investors@ab-science.com
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