ABSCIENCES (EPA:AB) AB SCIENCE: Publication of Long-Term Survival of Dogs with Mast Cell Tumours Treated with Masitinib
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Paris, 3rd January 2011, 8:30 amPublication of Long-Term Survival of Dogs with Mast Cell Tumours Treated with
Masitinib
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company
specialising in the research, development and commercialisation of protein
kinase inhibitors (PKIs), announces publication of increased long-term survival
with masitinib in canine mast cell tumour.
In new research published in the peer-reviewed scientific journal American
Journal of Veterinary Research, Dr Kevin Hahn (DVM, PhD) and colleagues report
on the effectiveness of masitinib for the treatment of nonresectable mast cell
tumours (MCTs) in dogs at 12 and 24 months after onset of treatment. This was a
follow-up study from the successful pivotal 6-month, phase III,
placebo-controlled clinical trial of masitinib in the treatment of dogs with
nonmetastatic grade 2 or grade 3 cutaneous MCTs. Masitinib, arguably the most
specific inhibitor of c-Kit available, was subsequently registered by the
European Medicine Agency (EMA) under the trade name Masivet(r), making it the
first approved targeted therapy in veterinary oncology. Masitinib recently
received conditional approval from the Food and Drug Administration (FDA) for
commercialisation under the trade name Kinavet-CA1.
Two major conclusions are drawn from this publication. First, the long-term
follow-up data provides further evidence that masitinib is effective in the
treatment of nonresectable MCTs and provided benefits in terms of long-term
survival. Moreover, masitinib treatment was shown to improve long-term survival
regardless of the subtype of MCT being treated (with respect to c-Kit mutational
status). Second, analysis revealed that control of disease at 6 months was
highly predictive of long-term survival, whereas short-term response at 6 weeks
was not.
Alain Moussy, Chairman and CEO of AB Science declared: " In the field of
oncology this survival is critically important to establish a drug as a
benchmark. Recent examples have shown that oncology products could reduce tumour
size in the short-term at a cost of toxicity but could not increase survival
over the longterm or even worse reduce survival. It is relatively difficult to
generate these long-term survival data because you need to follow patients in a
comparative manner (that is, masitinib versus existing standard of care) for
years, which AB Science has done. Significant improved survival has been
demonstrated, which is good news for dogs suffering from mast cell tumours ".
Publication is available from the AJVR website:
http://avmajournals.avma.org/doi/abs/10.2460/ajvr.71.11.1354.
AB Science is developing masitinib in veterinary medicine in oncology, but also
in non oncology diseases, such as atopic dermatitis in dogs or asthma in cats. A
list of the publications related to masitinib in veterinary medicine is provided
below.
Besides using the animal health segment as a source of revenues to finance its
clinical development program in human medicine, AB Science is also using the
veterinary medicine as a platform to discover new indications for its lead
compound masitinib and translate this use into human medicine. The first
application of this strategy was made recently (press release dated 8/10/2010)
with the decision to initiate a phase 3 study in metastatic melanoma expressing
JM mutation of c-Kit. This decision was facilitated by evidence showing that
masitinib could generate tumour response in animal with melanoma.
List of publications with masitinib in veterinary medicine
Area Title Type Source
ONCOLOGY SINGLE Gain-of-function mutations in the Publication Mol Cancer Res.
AGENT extracellular domain of KIT are (Létard et al.,
common in canine mast cell tumors. 2008)
Pre-clinical
Canine Mast Cell
Tumor
ONCOLOGY SINGLE Response to treatment with masitinib Abstract VCS 2009
AGENT of chemotherapy resistant, (Poster) (de Vos et al)
metastasized, canine cutaneous
grade 2 and 3 mast cell tumors:
a pilot study
Clinical Assessment of response to the Abstract ESVONC 2009
Pilot Study treatment with masitinib (MASIVET(r)) (de Vos et al)
Canine Mast Cell of chemo-resistant, grade 2 and 3
Tumor metastasized canine cutaneous mast
cell tumours: report of four cases
A novel c-Kit inhibitor (AB1010) Abstract VCS 2006
shows therapeutic potential in dog (Axiak et al)
mast cell tumors (DMCT)
Masitinib is safe and effective for Publication JVIM
the treatment of canine mast cell (Hahn et al.,
tumors 2008)
Evaluation of 12- and 24-month Publication AJVR
survival rates after treatment with (Hahn et al.,
masitinib in dogs with nonresectable 2010)
mast cell tumors.
Masitinib is safe and effective for Abstract ECVIM 2008
the treatment of canine mast cell (Poster) (Rusk et al.)
tumors
Masitinib reduces the onset of Abstract BSAVA 2009
metastasis and improves long-term (Oral) (Hermine et al.)
survival in dogs with measurable grade
2 and grade 3 mast cell tumours.
ONCOLOGY SINGLE Masitinib is effective in the treatmentAbstract BSAVA 2009
AGENT canine grade 2/3 mast cell tumours that (Oral)(Hermine et al.)
Pivotal Study only express WT c-kit
Canine Mast Cell Masitinib : Long-term efficacy follow- Abstract VCS 2008
Tumor up data on a pivotal phase III study (Poster) (Hahn et al)
in the treatment of dogs with measurable
grade II and III mast cell tumors
Short-term tumor response to tyrosine Abstract VCS 2009
kinase inhibitors is not predictive of (Oral) (Hermine et al)
long-term survival in canine mast cell
tumors: 2- year follow-up data from
the masitinib pivotal field study
Masitinib in the treatment canine grade Abstract VCS 2009
2/3 mast cell tumors that only express (Oral) (Hermine et al)
WT c-Kit
Impact of masitinib on metastatic mast Abstract VCS 2009
cell tumors and on the emergence of (Poster)(Hermine et al)
metastasis from non-metastatic tumors
Evaluation of masitinib in the Abstract ESVONC 2009
treatment of canine mast cell tumors: (Oral) (Hermine et al)
Long-term follow-up efficacy data from
a phase III clinical study
Fifty months and counting: Case studies Abstract VCS Oct 2010
exemplifying the long-term survival of (Poster) (Ahn et al)
masitinib in dogs with non-resectable
grade 2 mast cell tumors
First-line and rescue therapy with Abstract VCS Oct 2010
masitinib integrated protocols for (Oral) (de Vos et al)
canine cutaneous mast cell tumors
ONCOLOGY Masitinib is a chemosensitizer of Abstract VCS 2008
COMBINATION WITH canine tumor cell lines (Poster)(Thamm et al.)
CHEMOTHERAPY
Pre-clinical
In vitro Oncology
Targeted therapy with masitinib in Abstract VCS March 2010
canine and feline tumours in two (Oral)(Brearley et al.)
European veterinary oncology centres
Evaluation of safety of masitinib in Abstract VCS March 2010
combination with carboplatin in (Oral) (Ogilvie)
advanced canine tumors
Evaluation of safety of masitinib Abstract VCS March 2010
in combination with doxorubicin in (Oral) (Ogilvie)
advanced canine tumors
ONCOLOGY A c-kit inhibitor (Masivet(r)) shows Abstract ESVONC 2010
COMBINATION WITH therapeutic potential in dog (Oral) (Roos et al)
CHEMOTHERAPY neurofibrosarcoma
Masitinib for maintenance chemotherapy Abstract ESVONC 2010
Clinical of 2 dogs with T-cell multicentric (Poster)(Serres et al)
Oncology in dogs lymphoma
Drug-induced minimal change nephropathy Publication J Vet
in a dog Intern Med
(Sum et al. 2010)
Masitinib - The Efficacy of Targeted Publication VCS Summer
Therapy in Veterinary Medicine Newsletter
(Ogilvie et
al. 2010)
INFLAMMATORY A tyrosine kinase inhibitor targeting Abstract NAVDF 2009
DISEASES c-kit for chronic inflammatory diseases (Oral) (Hermine et al)
involving mast cells
Pre-clinical
mice
Masitinib for the treatment of canine Publication Vet Research
atopic dermatitis: a pilot study Communications
(Daigle et al.
2009)
INFLAMMATORY Efficacy and safety of masitinib in Abstract NAVDF 2008
DISEASES the treatment of atopic dermatitis in (Poster) (Beale et al.)
dogs
Clinical Masitinib, oral tyrosine kinase
Pilot Study inhibitor, in the treatment of canine Abstract EVCD 2010
Canine Atopic atopic dermatitis (CAD): results of (Oral) (Cadot et al)
Dermatitis a double-blinded, multinational,
pivotal, phase 3.
The tyrosine kinase inhibitor Abstract New Trends
masitinib (Masivet(r)) is effective (Oral) in Allergy
for treatment of atopic dermatitis VII Congress
in dog 2010 (Cadot
et al)
INFLAMMATORY 24th Annual Congress of the ECVD-ESVD, Abstract Vet Derm
DISEASES 23-25 September 2010, Firenze, Italy (Oral) (Cadot et al.,
Clinical 2010)
Pivotal Study
Atopic Dermatitis
INFLAMMATORY Pharmacokinetics of masitinib in cats Publication Vet. Res.
DISEASES Com.
(Bellamy et
Cats al.,2009)
Evaluation of the receptor tyrosine Abstract VCS Oct 2009
kinase inhibitor, masitinib mesylate, (Oral) (Daly et al)
in feline vaccine associated sarcoma
cell lines and healthy cats
About Canine Mast Cell Tumour
Mast cell tumour (MCT), also known as a mastocytoma, is the most common
cutaneous malignant neoplasm in dogs, accounting for 16 to 21% of all skin
tumours. The behaviour and progression of MCTs are highly heterogeneous. They
range from slow-growing tumours with a low potential for metastasis (grade I) to
undifferentiated, aggressive tumours (grade II and III) with a high potential
for metastasising to local lymph nodes, the liver, spleen and bone marrow
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 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
Citigate Contacts Citigate Dewe Rogerson :
Dewe Rogerson Agnès Villeret - Tel: +33 1 53 32 78 95 -
agnes.villeret@citigate.fr
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