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AB Science (AB.PA) Reports Positive Clinical Study Data: Masitinib Significantly Extends Overall Survival as Compared to Pfizer Inc. (PFE)'s Sutent®in Gleevec®-resistant GIST


2/1/2012 10:55:07 AM

PARIS--(BUSINESS WIRE)--Regulatory News: AB Science SA (Paris:AB) (NYSE Euronext - FR0010557264 - AB) today announced encouraging results from a phase 2 study with its investigational drug, masitinib, in Gleevec®-resistant gastrointestinal stromal tumors (GIST). Masitinib significantly improved overall survival in patients with Gleevec®-resistant gastrointestinal stromal tumors (GIST) as compared to Sutent® (sunitinib) from Pfizer, a drug approved for second-line treatment of GIST, currently the standard of care for these patients. In this study, 44 patients with inoperable, locally advanced or metastatic GIST and showing disease progression while treated with Gleevec® (imatinib) (400 to 800 mg/day) received either masitinib (23 patients) at 12 mg/kg/day or Sutent® (21 patients) until progression. After a median follow-up of 14 months, median overall survival was not reached for masitinib versus 15 months for Sutent® (p=0.022 HR:3.2). After 18 months, 79% of patients treated with masitinib were still alive, versus 20% for patients treated with Sutent®. After 2 years, 53% of patients treated with masitinib were still alive, versus 0% for the patients treated with Sutent®.

The study also demonstrated that masitinib was significantly better tolerated than Sutent®. The safety profile of masitinib was better than that of sunitinib, with a significantly longer Safety Event Free Survival (p=0.002), and a lower occurrence of severe adverse events. In masitinib treated patients, nausea, diarrhea and asthenia were the most common related adverse events. Full data has been submitted for publication to the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting.

Axel Le Cesne, MD (Institut Gustave Roussy, France), the principal investigator of this study declared: “Given this substantial advantage in survival coupled with lower toxicity of masitinib as compared with Sutent®, we believe that masitinib is an important step forward in the treatment of GIST.”

Olivier Hermine, MD, PhD, President of the Scientific Committee of AB Science commented: “Masitinib differs from Sutent® by its selectivity profile. Unlike Sutent®, which targets a broad spectrum of protein kinases, masitinib is very selective, which brings better tolerability. Furthermore, in addition to killing cells that make up the tumors, masitinib has a complementary mode of action that may also kill cancer stem cells and trigger an immune response, which may further enhance its efficacy. These promising results in second line treatment of GIST, which correlate with the encouraging results previously reported in the first line treatment of GIST, tend to confirm that masitinib has an original mechanism of action that may translate into improved survival.”

About GIST

Gastrointential stromal tumor (GIST) is a sarcoma, which is a type of cancer that develops in the cells of the body’s connective or supportive tissues. GIST arises within the gastrointestinal tract. It is estimated that approximately 5,000 to 6,000 new patients are diagnosed with GIST each year in the United States. In 2010, the global GIST therapeutics market was valued at $920 million, and forecast to grow at a rate of 2% annually.

Masitinib received orphan drug designation in the treatment of GIST from both the FDA and EMA.

About masitinib

Masitinib is an investigational 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, inflammatory diseases and 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 tumor 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 remodeling, 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 specializing in the research, development and commercialization of novel targeted therapies for patients with cancer and other significant unmet medical needs including inflammatory and central nervous system diseases. AB Science has developed a proprietary portfolio of protein kinase inhibitors (PKIs), a new class of targeted molecules whose action is to modify signaling pathways within cells. AB Science’s lead product, masitinib, has already been registered in veterinary medicine in Europe and the US, and is currently in 9 phase 3 human studies, including 8 studies on-going in pancreatic cancer, GIST, 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, France, and is listed on Euronext Paris (Ticker: AB).

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 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.

Contacts

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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