On July 7, the U.S. Food and Drug Administration suspended a Phase II clinical trial that was testing a drug product made by Juno Therapeutics, Inc. Juno is a biopharmaceutical company founded in 2013. The company has the remit to develop a pipeline of cancer immunotherapy drugs.
The clinical trial in question involved a treatment called JCAR015. This experimental medication was being tested on adult patients with either relapsed or refractory B cell acute lymphoblastic leukaemia. The drug forms part of what is known as a CAR-T program. CAR-T is a type of engineered T-cell (an immune system cell) which is transformed in vitro to recognize cancer cells. CAR-T is a type of personalized medicine and one of the main developments in the field of blood cancers.
The program has been suspended, at the Phase II phase, after three deaths, which could be treatment-related. One person died in May and the other two at the start of July. The three deaths were caused by cerebral edema (which is a build up of fluid in the brain). The company Juno has stated, according to Labiotech, that the edema could have arisen due to a “very rapid expansion of the cells, which was only seen in specific conditions.” It is noted that the three patients were also administered an established chemotherapy drug called fludarabine and it is possible that the deaths related to the use of the established drug.
According to CNBC, the U.S. FDA has requested that Juno submit a detailed response to the suspension. This will require Juno to revise documents like an informed consent form and trial protocol. Juno CEO Hans Bishop told Bizz Journals that “the FDA have told us they will review these documents on an expedited basis.”
On Twitter, pharmaceutical news group pharmalot (@pharmalot) expressed a concern about rushing into re-starting the trial, tweeting: “Are patient deaths in the $Juno cancer trial just a ‘bump in the road?’ What some Wall Street wags say…”
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.
