Track topics on Twitter Track topics that are important to you
Paris, 1st of December 2016, 6.30pm
AB Science will present phase 3 results in severe systemic mastocytosis at the Journées Dermatologiques de Paris 2016, organized by the French Society of Dermatology
Important step in the rapid treatment of patients in case of masitinib marketing authorization
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), today announced that results from its phase 3 trial in severe systemic mastocytosis have been selected for an oral presentation at the congress 'Journées Dermatologiques de Paris 2016', organized by the French Society of Dermatology (December 6 - 10, 2016, Paris, France).
The Journées Dermatologiques de Paris is the annual congress of the French Society of Dermatology. This congress hosts more than 5,000 professionals from all over the world with an interest in dermatology, with a program that promotes research and education.
Abstracts were selected by the selection committee of the Congress (three independent readers and one Jury plenary meeting), on the basis of their scientific quality. The abstract for this presentation will be published in the scientific journal 'Annales de Dermatologie et de Vénéréologie' (Volume 143, Issue 12, Supplement, December 2016, Pages S188-S189).
Professor Olivier Hermine, President of the Scientific Committee of AB Science and coordinator of the Reference Center for Mastocytosis (CeReMast, Paris, France), will deliver this oral presentation on Thursday, 8th December.
Professor Olivier Hermine said: "For indolent forms of mastocytosis, the diagnosis of the disease is often first made by dermatologists, since both cutaneous and systemic forms of mastocytosis are typically associated with cutaneous symptoms, leading to a dermatologist consultation. It is therefore very important that dermatologists are aware of the results for masitinib in this indication. We are very pleased with the interest shown by the dermatologist community, because their intervention represents an important step in the rapid treatment of patients in case of possible future marketing authorization for masitinib in this indication".
Masitinib for the treatment of severely symptomatic indolent and smouldering systemic mastocytosis: a randomized, placebo-controlled, phase 3 study
Abstract: # JDP2016/ABS-1757
Session Title: Thérapeutique 1
Date, Location: Thursday, December 8 (4.15pm), Room: Amphi Havane
The phase III study results showed that masitinib was superior to optimal symptomatic treatment on the primary efficacy analysis as well as secondary efficacy analyses. This phase 3 randomized study compared masitinib plus optimal symptomatic treatment versus placebo plus optimal symptomatic treatment in adult patients with severe systemic mastocytosis, with or without D816V mutation of c-Kit. Study results showed that masitinib administered at 6 mg/kg/day was superior to the comparator, as measured by the cumulative 75% response rate until week 24 on the handicaps of pruritus or flushes or depression or fatigue (4H75% response). The 4H75% response was 18.7% for the masitinib treatment-arm versus 7.4% for the placebo treatment-arm (p=0.0076, Odds ratio=3.63) in the mITT population (primary analysis). Success in the primary analysis was also supported by positive outcomes in secondary analyses.
Based on these results, AB Science filed for registration to European Medicines Agency (EMA) in April 2016.
Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Based on its unique 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. In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglia and consequently the inhibition of the activation of the inflammatory process, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases and the degeneration of these diseases.
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment in cancers, inflammatory diseases, and central nervous system diseases, both in humans and animal health.
AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine in Europe and in the USA. The company is currently pursuing twelve phase 3 studies in human medicine in metastatic prostate cancer, metastatic pancreatic cancer, relapsing metastatic colorectal cancer, relapsing metastatic ovarian cancer, first-line GIST, second-line GIST, metastatic melanoma expressing JM mutation of c-Kit, relapsing multiple myeloma, relapsing T-cell lymphoma, severe asthma, amyotrophic lateral sclerosis, Alzheimer's disease and progressive forms of multiple sclerosis. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).
Further information is available on AB Science's website: www.ab-science.com.
Forward-looking Statements - AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance.
These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significally differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents filed by AB Science with the Autorité des Marchés Financiers (AMF), including those listed in the Chapter 4 "Risk Factors" of AB Science reference document filed with the AMF on November 22, 2016, under the number R. 16-078. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.
For additional information, please contact:
Financial Communication & Media Relations
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...