AB Science provides an update on the restructuring of its clinical development department in 2018
Paris, December 19, 2018, 6pm
Update on restructuring of the AB Science clinical development department in 2018
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialized in the research and development of protein kinase inhibitors (PKIs), has completed reorganization of its clinical development activity to ensure compliance with good clinical practices as a consequence of the ANSM decision to put AB Science studies on clinical hold in France.
AB Science provides here the main achievements of this restructuring.
Step 1: Restructuring of clinical development activity
AB Science implemented a new organization of its clinical development activity, with the recruitment of 9 professionals each having a minimum of 15 years of experience in the pharmaceutical industry. As part of this restructuring, 6 new positions have been created and 3 positions have been replaced.
Step 2: Implementation of a new Quality Management System (QMS)
A new Quality Management System (QMS) has been implemented, the original system having been identified as the root cause of the findings reported during previous inspections:
- Implementation of a CAPA plan (corrective and preventive action plan) by AB Science Quality Assurance department.
- Update of all Standard Operating Procedures (SOP) and Working Instructions (WI) of the Company.
- Audits of AB Science systems, clinical sites and clinical vendors by external and independent auditors. Globally, more than 100 audits have been performed.
Step 3: Reassessment of all masitinib safety data
Throughout 2018, AB Science performed a full reassessment of masitinib safety data:
- Remonitoring of clinical data in the clinical sites to ensure that no serious adverse event (SAE) was left unreported.
- Implementation of a new validated Pharmacovigilance database.
- Medical reassessment and transfer of all serious adverse events in this new Pharmacovigilance database.
- Impact analysis of this new Pharmacovigilance database on the 2018 Investigator Brochure.
- Complete revision of the 2018 Investigator Brochure, including the implementation of signal detection on all potential risks. This Investigator Brochure presents the safety data of more than 6,000 randomized patients, approximately half of which are from non-oncology studies.
Step 4: ANSM inspection
An ANSM inspection was recently conducted to ensure that the conditions required to lift the clinical hold have been met.
AB Science will disclose the agency decision once available. At this stage, AB Science does not intend to provide any information regarding the timing of the ANSM decision.
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.
AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, and inflammatory diseases. 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 significantly 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.
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