That's done by genetically modifying a patient's immune T cells to attack the cancer. All three patients who died in the trial suffered from swelling in the brains due to excess fluids.
The first death happened back in May. Juno Therapeutics, which is based in Seattle, reported it to the Food and Drug Administration. Moreover, on June 30, 2016-prior to the disclosure of these deaths-Juno's CEO Bishop Hans Edgar sold over $4.4 million worth of the Company's stock. Most professional clinical-trial standards require patients to be informed when new risks are discovered during the course of testing, and the drug company was criticized for not letting the sick patients know the man had died. Those 20 have already received their treatment, as JCAR015, as a one-time infusion.
"No doubt it is hard for the physicians who are looking after these patients and their families", said Bishop.
"Bottom line, we still have high hopes for Juno's CAR-T platform, but given the near/medium term uncertainty, we see better opportunities elsewhere in our universe and are downgrading to neutral". However, he urged people not to rush to that conclusion, stating: "This is not the case".
PIXABAY, ALLINONEMOVEFollowing the deaths of three patients in a phase II cancer immunotherapy clinical trial, Juno Therapeutics has put the breaks on the study.
This particular type of leukemia is a highly aggressive blood cancer that grows rapidly if a patient is not being treated. Without going into the scientific details, Juno said that it could resume the study promptly upon getting FDA approval.
The clinical hold was initiated after two patient deaths last week, which followed the recent addition of fludarabine to the pre-conditioning regimen. It has proposed continuing the study without fludarabine. The FDA asked Juno to submit new documents, including a new patient consent form and a new protocol.
Dr. Stephan Grupp, Novotny Professor of Pediatrics at the University of Pennsylvania Perelman School of Medicine, is running a similar trial funded by Novartis CAR T cells to treat pediatric leukemia patients. And the FDA plans on an expedited review process for the JCAR015 trial paperwork, he said.
Kite Pharma Inc. KITE, a clinical-stage biopharmaceutical company that focuses on development of cancer immunotherapy products, saw its stock fall over 8% in morning trading, and Bluebird Bio Inc. Once these juiced-up CAR-T cells are reintroduced into the patient's bloodstream, they should prevent cancer from spreading and taking hold.
Republished with permission from STAT.
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