ABSCIENCES (EPA:AB) AB SCIENCE: Authorization to initiate phase 2 in T-Cell Lymphoma with masitinib
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24/01/2011 08:00
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Paris, January 24th 2011, 8 am
AB Science announces authorization to initiate phase 2 in T-Cell Lymphoma with
masitinib
Masitinib clinical development program in haematological malignancies now
accounts for 2 indications
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company
specialising in the research, development and commercialization of protein
kinase inhibitors (PKIs), announced today the authorisation granted by Afssaps
to start a phase 2 clinical study in T-Cell lymphoma with masitinib.
AB Science is now evaluating masitinib in two indications in haematological
malignancies, T-Cell lymphoma, in phase 2, and multiple myeloma in phase 3.
As for the phase 2 recently started in human in metastatic melanoma, this
development in T-Cell lymphoma was initiated after observation of cases of
sustained complete responses reported in dogs suffering from T-Cell lymphoma
and treated with masitinib after failure of previous line of treatment.
This phase 2 in T-Cell lymphoma in human will evaluate masitinib in
combination with dexamethasone and masitinib in combination with gemcitabine
and dexamethasone, in patients with relapsed or refractory peripheral T-cell
lymphoma.
Alain Moussy, Chairman and CEO of AB Science declared " After registration of
masitinib both in Europe and in the USA in canine mast cell tumours, the
veterinary platform continues to create value for the development of masitinib
in human medicine by delivering information on what indications could be
pursued. This type of cross species development is encouraged by NCI guidelines
for drugs developable in the two species, which is the case of tyrosine kinase
inhibitors since kinases are fairly homologous across mammals. This phase 2 is
fully financed ".
Details of the clinical development program (on next page).
About peripheral T-Cell Lymphoma
Peripheral T-cell lymphomas (PTCL) represent approximately 15% of all
non-hodgkin lymphomas, therefore accounting for around 10.000 new cases per
annum in the USA. These lymphomas usually present at diagnosis in stage III or
IV, and are often aggressive. There is an important unmet medical need for
peripheral T-Cell lymphoma in resistance to one line chemotherapy.
About NCI guidelines
The National Cancer Institute's Center for Cancer Research (CCR) has launched
the Comparative Oncology Program (COP) to help researchers better understand
the biology of cancer and to improve the assessment of novel treatments for
humans by treating pet animals-primarily cats and dogs-with naturally
occurring cancer.
Further information is available at
https://ccrod.cancer.gov/confluence/display/CCRCOPWeb/Home
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 nine phase 3 studies in human
medicine, including four studies on-going in pancreatic cancer, GIST, in
metastatic melanoma expressing JM mutation of c-Kit, 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
* * *
DETAILS OF THE CLINICAL DEVELOPMENT PROGRAM IN HEMATOLOGICAL MALIGNANCIES
Characteristics of the phase 3 in Multiple Myeloma
This is a prospective, multicenter, randomized, double-blind,
placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and
safety of masitinib 9 mg/kg/day in combination with bortezomib and
dexamethazone to placebo in combination with bortezomib and dexamethazone in
the treatment of patients with relapsing multiple myeloma who received one
previous therapy.
Patients will be randomized into two groups:
* Group 1: Patients will receive masitinib at 9 mg/kg/day in combination
with bortezomib and dexamethazone
* Group 2: Patients will receive placebo in combination with bortezomib and
dexamethazone
The primary criterion will be the Overall Progression Free Survival (PFS)
according to International Myeloma Working Group criteria 2009 (IMWG /revised
Bladé criteria).
Characteristics of the phase 2 in T-Cell Lymphoma
A prospective,multicenter, randomised, open-label,
three-parallel groups, phase 2 study to evaluate the efficacy and safety of
masitinib with dexamethasone, gemcitabine with dexamethasone and the
combination of masitinib, gemcitabine and dexamethasone in patients with
relapsed or refractory peripheral T-cell lymphoma.
Patients will be randomized in three groups:
* Group 1: Patients will receive masitinib orally at 7.5 mg/kg/day twice
daily in combination with dexamethasone
* Group 2: Patients will receive dexamethasone in combination with
gemcitabine
* Group 3: Patients will receive masitinib orally at 6 mg/kg/day twice daily
in combination with dexamethasone and gemcitabine.
The primary criterion will be the Overall Progression Free Survival (PFS),
defined as the delay between the date of randomisation to the date of
documented progression or any cause of death during the study.