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France Banned AB Science Drug Studies Because of Side Effects


























Image source: FRUGAL-CAFE

French regulators in 2012 prohibited biotechnology company AB Science from conducting nine clinical trials of its experimental drug in non-life-threatening illnesses because of the treatment’s side effects.

The National Agency for Drug Safety, known as ANSM, ordered AB Science Chief Executive Officer Alain Moussy to stop trials of masitinib in Alzheimer’s disease, severe asthma, chronic obstructive pulmonary disease, multiple sclerosis and rheumatoid arthritis and painful bladder syndrome, according to a May 2012 letter from the agency that Bloomberg News obtained this month under France’s public records law.

“There is an increased risk of serious and severe adverse events that have the potential to be fatal,” according to the letter, which the regulator hadn’t publicly disclosed until now.

The agency’s view contrasts with AB Science’s contention that mastinib has the potential to treat a wide range of diseases and has manageable side effects. Still, several other countries have allowed the Paris-based company to study the drug in inflammatory and neurological conditions as well as in 11 types of cancer.

“It’s not rare for regulators, and it’s their prerogative, to have diverging opinions on molecules that are in early-stage development for both oncology and other areas,” said AB Science Chief Financial Officer Laurent Guy in an e-mailed comment. “Further development will bring final responses about masitinib’s efficiency and the balance between benefit and risk for each type of illness.”

Third Attempt

The company has amended how it conducts its clinical trials since the ANSM decision, he said. Also, signs of toxicity when the drug is used to treat cancer have to be analyzed with caution, because the dosage is higher in cancer and masitinib is administered along with chemotherapy, Guy said.

AB Science, founded in 2001 in Paris, has been studying the drug for more than 12 years and hasn’t yet succeeded in gaining permission to sell it for human use. The company aims to make a third attempt this year to get masitinib approved.

The risk of side effects is too high for people whose illnesses aren’t immediately life-threatening, ANSM said in its 2012 letter. The agency cited Stevens-Johnson syndrome, in which cell death causes the outer layers of the skin to separate from the one below, and neutropenia, in which patients showed dangerously low levels of infection-fighting white blood cells. The news agency APM International reported the decision in 2013, citing sources familiar with the matter.

ANSM hasn’t authorized new clinical trials since its decision and hasn’t received data to challenge its evaluation, the regulator said Wednesday.

Rare Disorder

According to clinical trial registers, the only non-cancer trial of masitinib in France is in mastocytosis, a rare disorder of the immune system. Moussy created the company in 2001 because someone close to him had the illness. The company aims to file for approval in mastocytosis by the end of the year if a late- stage clinical trial shows the drug works. The European Union has rejected applications to approve masitinib for pancreatic and stomach cancers.

AB Science is conducting studies in Alzheimer’s, asthma, multiple sclerosis and rheumatoid arthritis in several other EU countries as well as in the U.S., clinical trial registers show. The U.S. Food and Drug Administration declined to comment on those studies as well as a psoriasis trial it authorized.

The study in chronic obstructive pulmonary disease is only being conducted in Spain, which is also the sole country to have approved masitinib trials in acute ischemic stroke, depression and a rare disorder called progressive supranuclear palsy, registers show. Spain’s regulator AEMPS declined to comment.

French Investment

Masitinib has been given to more than 2,000 patients around the world, according to an AB Science investor presentation. Studies are approved by an independent committee that has access to data for all the company’s studies, Guy said.

The French state’s investment bank, BPI France, awarded AB Science 5.9 million euros ($6.5 million) in grants and loans in 2013 for research on Alzheimer’s on the basis of approvals granted by European regulators, Antoine Boulay, a spokesman for the bank, said by telephone. BPI France has no knowledge of ANSM’s decision, Boulay said, refusing further comment.

--With assistance from Alan Katz in Washington.

Story Source: The above story is based on materials provided by WASHINGTONPOST
Note: Materials may be edited for content and length


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