Investigación "mortal": Juno CART-T / Biotrial

Three patients in a study testing the use of genetically engineered cells as a treatment for cancer have died from swelling in the brain, dealing a setback to one of the most exciting pursuits in oncology. 

Juno Therapeutics, the company conducting the clinical trial, said on Thursday that the Food and Drug Administration had temporarily halted the study. 

The deaths were “difficult and humbling for everyone involved,” Hans Bishop, the company’s chief executive, said in a conference call with securities analysts. 

Shares of Juno stock plunged 27 percent in after-hours trading. 

Mr. Bishop and other Juno executives said they believed that the problems resulted from a combination of the particular cells being used and a chemotherapy drug. The company proposed to the F.D.A. that the trial continue without the drug. 

It is not clear whether the agency will agree, or when it will make a decision, though Juno executives said it could be within 30 days. 

Juno is working on what is known as CAR-T therapy. This involves taking blood from a patient to extract immune cells, genetically engineering them to make them kill cancer cells, and then putting them back into the bloodstream to go to work.(Más)

Ver:
Juno and Novartis settle CAR-T patent fight with little fanfare

FDA suspends clinical trial after three deaths

This is the second clinical trial issue of concern this year. Earlier in 2016, a clinical trial in Rennes, at a private clinic, which involved 128 people saw eight people become seriously affected. One person died, and four have brain injuries. (Más)


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Biotrial: Ensayo mortal / Bial