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Last $17.49 USD
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ab science sa (ABSCF) Details

AB Science S.A., a pharmaceutical company, engages in the research, development, and commercialization of protein kinase inhibitors for use in human and veterinary medicines in the United States and Europe. Its lead compound includes Masitinib, a tyrosine kinase inhibitor that targets mast cells and selected kinases, including c-Kit, PDGR, and Lyn. The company focuses on therapies for the treatment of cancer, inflammatory diseases, and central nervous system diseases. It is also pursuing eight on-going phase III studies in human medicine in GIST, metastatic melanoma expressing JM mutation of c-Kit, multiple myeloma, mastocytosis, severe persistent asthma, rheumatoid arthritis, and progressive multiple sclerosis. The company markets its Masitinib under the Masivet brand name for the veterinary market in Europe. Its products are used by hospitals and specialist physicians. AB Science S.A. was founded in 2001 and is headquartered in Paris, France.

112 Employees
Last Reported Date: 08/29/14
Founded in 2001

ab science sa (ABSCF) Top Compensated Officers

Co-Founder, Chairman, Chief Executive Officer...
Total Annual Compensation: €456.7K
Compensation as of Fiscal Year 2013.

ab science sa (ABSCF) Key Developments

AB Science S.A. Announces the Publication of Results from the First Randomized Phase 3 Study of Masitinib in Treatment of Advanced Pancreatic Ductal Adenocarcinoma

AB Science S.A. announced the publication of results from the first randomized phase 3 study of masitinib in treatment of advanced pancreatic ductal adenocarcinoma (PDAC). In patients with over-expression of ACOX1 in blood, administration of masitinib in combination with Gemzar produced a statistically significant overall survival advantage of +6.1 months (Hazard Ratio=0.23[0.10;0.51]) when compared with placebo administered in combination with Gemzar. In the pain subgroup, administration of masitinib in combination with Gemzar produced a statistically significant overall survival advantage of +2.6 months (Hazard Ratio=0.62[0.43;0.89]) when compared with placebo administered in combination with Gemzar. Safety of the combination remained acceptable with no overall detrimental effect on quality of life. A new confirmatory phase 3 trial of masitinib in advanced pancreatic cancer has been initiated, with an objective to replicate these promising results in a prospective manner.

AB Science's Masitinib Receives Orphan Drug Designation for Amyotrophic Lateral Sclerosis from FDA

AB Science SA announced that the U.S. Food and Drug Administration (FDA) has granted the company Orphan Drug designation for masitinib in the treatment of amyotrophic lateral sclerosis. The FDA's Office of Orphan Drug Products Development reviews applications for Orphan Drug status to support development of medicines for underserved patient populations, or rare disorders that affect fewer than 200,000 people in the United States. The successful application submitted by AB Science and the FDA granting of Orphan Drug status entitles the company to a seven-year period of marketing exclusivity in the United States for masitinib, if it is approved by the FDA for the treatment of amyotrophic lateral sclerosis. Orphan Drug status also enables the company to apply for research grant funding for Phase I and II Clinical Trials, tax credits for certain research expenses, and a waiver from the FDA's application user fee, as well as additional support from FDA and a potentially faster regulatory process. A phase 3 is currently on-going with masitinib in ALS. In January 2015, the external Data and Safety Monitoring Board (DSMB) recommended the continuation of this phase 3 study based upon review of the latest safety data. The DSMB was created as part of the company's pivotal clinical study evaluating masitinib in the treatment of amyotrophic lateral sclerosis. Amyotrophic lateral sclerosis is a rare degenerative disorder that results in progressive wasting and paralysis of voluntary muscles. There are approximately 30,000 people with ALS in the European Union and 15,000 in the US, with more than 7,500 new cases diagnosed each year in Europe and 4,500 in the US. Almost 50% of ALS patients die within 3 years and 90% die within 5 years.

AB Science SA Announces Positive Efficacy and Safety Results from Phase 2 Study with Masitinib in Patients with Triple Negative Breast Cancer

AB Science SA announced positive efficacy and safety results from a phase 2 study with masitinib in patients with triple negative breast cancer (TNBC). This was a prospective, multicenter, open-label, randomized, uncontrolled, phase 1b/2 study to evaluate efficacy and safety of masitinib in association with chemotherapy for the treatment of TNBC. Patients received masitinib in combination with carboplatin and/or gemcitabine. In the cohort receiving masitinib in combination with carboplatin and gemcitabine, 37% of patients enrolled were in first-line of treatment, 16% were in second-line of treatment and 47% were in third-line of treatment or beyond. For the overall cohort, median overall survival was 10.2 months and median progression-free survival was 4.7 months. Objective response rate was 43%. The efficacy of masitinib in combination with carboplatin and gemcitabine compares favorably to median OS of 7.7 months and response rate of 32% published for carboplatin plus gemcitabine in the treatment of TNBC1. A statistical test was pre-defined in this phase 2 study in order to detect a superiority trend on the overall survival between the median value of the study and historical median value. The result of this test enables to determine whether or not a confirmatory phase III could be initiated. This statistical test is based on the upper bound for the confidence interval of Hazard Ratio lower than 1, estimated from the median Overall Survival (OS) observed in this phase 2 study and the historical benchmark. In the masitinib + gemcitabine + carboplatin group, upper bound of the confidence interval for OS hazard ratio is estimated to 0.70, permitting to justify the launch of a larger study. AB Science is currently discussing with the experts of the disease the next steps of clinical development. Full safety and efficacy data has been submitted for publication to the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. TNBC is more aggressive than other forms of breast cancer, with fewer treatment options and no drug registered in this specific indication. The benchmark for median overall survival in metastatic breast cancer is estimated at 18 months2 in second-line of treatment, TNBC not included, whereas it is less than 7.7 months in second-line treatment of TNBC. Hence, there is still a high unmet medical need in this disease. Breast cancer remains the second most common cancer in the world, and kills more women than any other cancer type. The incidence of breast cancer is reported as approximately 600,000 patients in the USA and Europe, and the mortality rate was of 130,000 patients3. It is estimated that 15% of patients have TNBC. It is also estimated that up to 40% of those diagnosed with breast cancer will develop advanced disease within 10 years. With these hypotheses, the number of eligible patients for treatment of advanced triple negative breast cancer is estimated to be 36,000 per annum in Europe and USA.


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