AB Science announces that FDA approves first compassionate use of masitinib in amyotrophic lateral sclerosis
PARIS, July 11, 2016 -- AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialized in the research, development and marketing of protein kinase inhibitors (PKIs), announces that the FDA granted a Single Patient IND for Compassionate Use of masitinib for patient with amyotrophic lateral sclerosis (ALS).
FDA received the first request for single compassionate use of masitinib in ALS, and accepted this request after reviewing the briefing document that was submitted by AB Science based on the interim results of the on-going phase 2/3 study with masitinib in ALS.
"Compassionate use" is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.
Access to investigational treatments is requested by a physician and requires the FDA's review and authorization, and the permission from the drug manufacturer.
AB Science has indicated that it is willing to accommodate as many such requests as possible with masitinib in ALS until a clinical study can be initiated with masitinib in the USA or until masitinib is registered in amyotrophic lateral sclerosis.
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 first-line and second-line GIST, metastatic melanoma expressing JM mutation of c-Kit, multiple myeloma, metastatic colorectal cancer, metastatic prostate cancer, pancreatic cancer, T-cell lymphoma, severe asthma uncontrolled by oral corticosteroid, Alzheimer's disease, progressive forms of multiple sclerosis, and amyotrophic lateral sclerosis. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).
Further information is available on AB Science website: http://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
Tesla Cybertruck update: Is Elon Musk's futuristic pickup truck joining the 'Cyberpunk 2077' vehicle lineup?