ABSCIENCES (EPA:AB) Publication of human phase 2 results of Masitinib in the treatment of mastocytosis in the American Journal of Hematology

Transparency directive : regulatory news

22/10/2010 10:51

Paris, 21st October 2010, 6 pm

     Publication of human phase 2 results of Masitinib in the treatment of
                mastocytosis in the American Journal of Hematology

- The phase 2 study revealed a improvement in the treatment of indolent forms of
  mastocytosis
- The development of mastinib leads the way towards the treatment of this
  orphan disease
- An on-going phase 3 study aims at registering masitinib for this indication

AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company
specialising in the research, development and commercialisation of protein
kinase inhibitors (PKIs), announces that the results of a first human phase 2
study of masitinib carried-out in the treatment of mastocytosis have been
accepted for publication in the American Journal of Hematology (impact factor
2.61) in an article to be published under " Efficacy and safety of oral
masitinib for the treatment of indolent systemic and cutaneous mastocytosis with
handicap: a multicentre, open-label, dose ranging, phase 2a study ". The
objective of the study was to evaluate the activity of masitinib in patients
suffering from indolent forms of mastocytosis.

Alain Moussy, Chairman and CEO of AB Science declared: " This is a significant
achievement for patients and for AB Science in the development of masitinib in
this orphan disease. There is no registered treatment at this time in this
disease, which can be highly invalidating for patients. For the first time,
through this publication, we can show that the concept of targeting mast cells
is valid. This is opening the way to new treatments in this disease. AB Science
is currently conducting an international phase 3 aimed at registering masitinib
in indolent forms of mastocytosis ".

An abstract of this publication is already available on the American Journal of
Hematology: http://onlinelibrary.wiley.com/doi/10.1002/ajh.21894/abstract.
Publication in the paper version is scheduled for the coming months.

Characteristics of the phase 2 and results
This multicenter, non controlled, open label study was aimed at evaluating the
activity of masitinib after 3 months of treatment in 25 patients diagnosed as
having systemic or cutaneous mastocytosis and not bearing mutations of c-Kit.

Improvement was observed in all primary endpoints at week 12 including a
reduction of flushes, Hamilton rating (measuring depression), and pruritus as
compared with baseline by 64% (p=0.0005), 43% (p=0.0049), and 36% (p=0.0077),
respectively. 64% of patients showed an improvement of at least 50% of at least
one handicap, with sustainable improvement observed throughout an extension
phase (>60 weeks). Common adverse events were oedema, nausea, muscle spasms, and
rash, the majority of which were of mild or moderate severity and transient. In
conclusion, masitinib is a promising treatment for indolent forms of
mastocytosis with handicap and indicates acceptable tolerability for long-term
treatment regimens

Read the full publications about masitinib in human and veterinary medecine on
AB Science's website: www.abscience.com.

About masitinib

Masitinib is a new orally administered tyrosine kinase inhibitor that targets
mast cells, important cells for immunity, as well as a limited number of kinases
that play key roles in various cancers. Owing to its novel 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.
Through its activity of inhibiting certain kinases that are essential in some
oncogenic processes, masitinib may have an effect on tumour regression, alone or
in combination with chemotherapy. Through its activity on the mast cell and
certain kinases essential to the activation of the inflammatory cells and
fibrosing tissue remodelling, masitinib can have an effect on the symptoms
associated with some inflammatory and central nervous system diseases.

About AB Science
Founded in 2001, AB Science is a pharmaceutical company specialising in the
research, development and commercialisation of protein kinase inhibitors (PKIs),
a new class of targeted molecules whose action is to modify signalling pathways
within cells. Through these PKIs, the Company targets diseases with high unmet
medical needs (cancer, inflammatory diseases and central nervous system
diseases), in both human and veterinary medicines. Thanks to its extensive
research and development capabilities, AB Science has its own portfolio of
molecules. Masitinib, a lead compound, has already been registered in veterinary
medicine in Europe and is pursuing eight phase 3 studies in human medicine,
including three studies on-going in pancreatic cancer, GIST and mastocytosis.

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

This document contains prospective information. No guarantee can be given as
for the realisation 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 & Press Relations

Contacts Citigate Dewe Rogerson :
Agnès Villeret - Tel: +33 1 53 32 78 95 - agnes.villeret@citigate.fr

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ABSCIENCES (EPA:AB) Publication of human phase 2 results of Masitinib in the treatment of mastocytosis in the American Journal of Hematology

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