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The ANSM suspends tests of a molecule AB Science's lead

The National Agency of Drug Safety (ANSM) announced Thursday the suspension of clinical trials conducted by the pharmaceutical company AB Science for its lead compound, masitinib.

The reproach ANSM including AB Science not to have fulfilled its obligations to the authorities regarding the testing but also making unwanted tests that "the risks to patients are out of proportion with the expected benefit for them "said the agency in its decision published on its website.

"Lack of reliable efficacy data," "lack of control", "failures in terms of good clinical practice", the reasons given by the agency to justify its decision are many.

"The result is that clinical trials may not demonstrate a benefit of the experimental drug for patients participating in research", believes ANSM.

Contacted by AFP, AB Science could not be reached Thursday for comment on the decision ANSM.

Founded in 2001, AB Science has developed its lead compound, masitinib, which is an inhibitor of tyrosine kinase, an enzyme that plays a key role in the activation and inhibition of many cellular functions.

The molecule was tested for a dozen indication, including cancer, neurological and inflammatory diseases such as multiple sclerosis, and Lou Gehrig's disease.

The company had announced on March 31 19 have risen million, with European and American funds to finance its clinical development program until 2019 end.

Masitinib received last August the designation of "orphan drug" in the EU, a status intended to facilitate the development of medicines for rare diseases.

The molecule was obtained just before the same designation from the Food and Drug Administration (FDA).

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