Juno Therapeutics (JUNO) JCAR015 Phase II ROCKET Trial Placed on Clinical Hold
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Juno Therapeutics, Inc. (Nasdaq: JUNO) announced that it has voluntarily placed on hold the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia, known as the “ROCKET” trial. The clinical hold was initiated after two patients suffered cerebral edema earlier this week. One patient died and as of last night the other is not expected to recover.
Juno has notified the Food & Drug Administration of the voluntary hold and is working with the agency and the Data and Safety Monitoring Board to determine next steps. The company is assessing data from the cases and the trial and is evaluating its options regarding the JCAR015 program.
Juno’s trials and plans for its other CD19-directed CAR T cell product candidates, including JCAR017, are not affected.
Conference Call Information
Juno will host a conference call today to discuss today’s announcement beginning at 5:30 a.m. Pacific Time (PT) / 8:30 a.m. Eastern Time (ET). Analysts and investors can participate in the conference call by dialing (855) 780-7198 for callers in the United States and Canada and +1 (631) 485-4870 for international callers, using the conference ID# 26549311.
The webcast can be accessed live on the Investor Relations page of Juno's website, www.JunoTherapeutics.com, and will be available for replay for 30 days following the call.
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