Cellectis, a French cell therapy company, has received a suspension notice from the Food and Drug Administration (FDA) following the death of a patient. The company is carrying out studies to test treatment against two types of cancer using genetically modified cells. The first patient to be treated, a 78 year-old man with plasmacytoid dendritic cell leukaemia, has died. Cellectis has announced that it “is working closely with investigators and the FDA to resume the trials with an amended protocol”, using the same treatment but at lower doses.
Unlike its rival, Novartis, which received FDA authorisation last week for its gene therapy (see The United States approve initial gene therapy to combat leukaemia), Cellectis uses healthy donor cells as opposed to the patient’s own cells. Some of the side effects observed could be due to the origin of these cells.
- Success of gene therapy involving genetically modified cells
- Gene therapy en route to curing young girl with leukaemia?
Boursier.com (05/09/2017), Reuters (05/09/2017)