The Agence Nationale de la Sécurité des Médicaments (ANSM) told AB Science to suspend the studies last week (here in French). The regulator uncovered problems during a review of a trial examining masitinib for the treatment of mastocytosis that was conducted between 2009 and 2015.
AB Science SA declined to comment when contacted by in-Pharmatechnologist.
Masitinib is a protein kinase inhibitor being developed for a range cancers, inflammatory disorders and neuro-degenerative diseases. It is being examined in Phase III studies at sites across Europe, including several in France.
Paris-based AB Science confirmed the suspension on Friday, but predicted it would have limited impact. The firm explained the suspended French studies accounf for 5% of the patients involved in the wider masitinib clinical development programme.
AB Science also said: "An independent audit will be performed in the coming months in order to provide ANSM with confirmation that the system meets the GCP standards. ANSM confirmed that the clinical studies could restart in France following the positive results of this audit plan."
In addition, the firm pointed out it had implemented a new quality system in mid 2015, which is after the study reviewed by ANSM was conducted.
AB Science also said “the last 11 site inspections carried out by national health authorities outside France since mid-2015 have not identified any serious or severe adverse events that would have been left unreported.”
AB Science's decision to revamp pharmacovigilance and clinical quality systems in 2015 followed shortly after US regulators criticized the firm for failing to protect patients in pancreatic cancer and GIST (gastrointestinal stromal tumour) studies from 2009 to 2013.
At the time, the US Food and Drug Administration (FDA) said improper monitoring of three protocols meant AB Science was not able to identify and correct clinical investigators’ failures to report serious adverse events (SAEs).
The Phase III masitinib trials are being carried out in several European countries.
ANSM told us it has communicated its decision to the competent authorities of EU Member states.
To date, no other regulators have recommended studies be suspended.
An MHRA spokesperson told us “We are aware of the suspensions in France and are considering what action may be needed in the UK.”