AB SCIENCE : Recruitment of the First Patient for the Phase 3 Study on Gleevec®-Resistant GIST, Comparing Masitinib with Sunitinib

Postponement of communication on the results of the phase 3 study of masitinib in pancreatic cancer

Authorization of a new phase 2 study in oncology, in head and neck cancer

Regulatory News:

AB Science SA (Euronext Paris - FR0010557264 - AB)(Paris:AB), a pharmaceutical company specialized in research, development and commercialization of protein kinase inhibitors (PKI), announces today the recruitment of the first patient in a phase 3 study evaluating masitinib in patients with Gleevec^®-resistant gastro-intestinal stromal tumors (GIST) and provides an update on the development program of masitinib in oncology.

I - Recruitment of the first patient in a phase 3 study in Gleevec^®-resistant GIST

This is a phase 3, multicenter, randomized, open-label, controlled, two-parallel group study evaluating the efficacy and safety of masitinib as compared with sunitinib (Sutent^®) in GIST patients after progression under imatinib (Gleevec^®). This study will recruit around 200 patients from 50 sites around the world, randomized with a 1:1 ratio between masitinib and sunitinib. The primary end-point is overall survival (OS).

This phase 3 study comes after promising results were obtained in a phase 2 study with 44 patients in the same indication, where masitinib has significantly improved overall survival in patients in Gleevec^®-resistant GIST when compared with Pfizer's Sutent^® (sunitinib), currently the only registered drug for second-line treatment of GIST .

As a reminder, in this phase 2 study, after a median follow-up of 14 months, median overall survival was not reached for masitinib versus 15.2 months for Sutent® (p=0.015 HR: 0.29 [0.10 ; 0.84]). After 18 months, 79.9% [54.3% ; 92.1% ] of patients treated with masitinib were still alive, versus 20.2% [1.5% ; 54.6%] for patients treated with Sutent®.

Comprehensive and updated results from this phase 2 study will be presented as an oral communication at the 2012 ASCO (American Society of Clinical Oncology) Annual Meeting in Chicago (USA) on June 4^th, at 3:00 p.m.

II - Postponement of communication on the results of the phase 3 study of masitinib in pancreatic cancer

Communication of the phase 3 results of masitinib in pancreatic cancer, previously announced for April 2012 has been postponed.

This postponement is due to the analysis of all study data listed in the protocol taking longer than anticipated, and in particular the genetic data.

AB Science will communicate these results as soon as these data are completely processed.

III - Authorization of a new phase 2 study in oncology in Head and Neck cancer

The French Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) authorized a new clinical phase 2 study in oncology, in head and neck cancer.

The development program for masitinib in oncology currently includes 14 clinical studies - five phase 3 studies, one of which is finished (pancreatic cancer) and nine phase 2 studies.

Clinical Study		Use of masitinib		Status
Phase 3 studies
1- Pancreatic cancer		Combination with chemotherapy		Data analysis being finalized
2 - GIST First-line		Monotherapy		Recruitment ongoing
3- GIST in resistance to Gleevec® (Second-line)		Monotherapy		Recruitment ongoing
4 - Metastatic melanoma with JM mutation of c-Kit		Monotherapy		Recruitment ongoing
5 - Multiple Myeloma in first relapse		Combination with chemotherapy		Recruitment ongoing
Phase 2 studies
6 - Metastatic melanoma without JM mutation of c-Kit		Combination with chemotherapy		Recruitment ongoing
7 - Metastatic prostate cancer		Combination with chemotherapy		Recruitment ongoing
8 - Metastatic colorectal cancer		Combination with chemotherapy		Recruitment ongoing
9 - Metastatic non small-cell lung cancer		Combination with chemotherapy		Recruitment ongoing
10 - Triple negative breast cancer		Combination with chemotherapy		Recruitment ongoing
11 - Metastatic breast cancer		Combination with chemotherapy		Recruitment ongoing
12 - Metastatic gastric and oesogastric carcinoma		Combination with chemotherapy		Recruitment ongoing
13 - Relapsed or refractory peripheral T-cell lymphoma		Combination with chemotherapy		Recruitment ongoing
14 - Metastatic head and neck cancer		Combination with chemotherapy		Authorization from ANSM

About AB Science

Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of novel targeted therapies for patients with cancer or other important diseases with unmet medical needs, including inflammatory diseases and central nervous system diseases.

AB Science has developed its own portfolio of protein kinase inhibitors (PKIs), a new class of targeted molecules, the action of which is to modify signaling pathways within cells. AB Science's lead molecule, masitinib has already been registered in veterinary medicine in Europe and in the USA, and is being tested in ten phase 3 studies in human medicine - including one being analyzed in pancreatic cancer and eight on-going studies: GIST in first-line, GIST in second-line, metastatic melanoma expressing JM mutation of c-Kit, multiple myeloma, mastocytosis, severe persistent asthma, rheumatoid arthritis, and progressive multiple sclerosis. The company is headquartered in Paris and listed on Euronext Paris (ticker: AB).

More information is available on our 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
Contacts Citigate Dewe Rogerson:
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agnes.villeret@citigate.fr
or
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