The first participant has been enrolled in an exploratory Phase 2 clinical trial evaluating Jazz Pharmaceuticals’ (NASDAQ:JAZZ)
defibrotide for the prevention of neurotoxicity in patients with
relapsed/refractory diffuse large B-cell lymphoma (DLBCL) receiving
Gilead Sciences’ (NASDAQ:GILD) CAR T therapy Yescarta (axicabtagene ciloleucel).
The first part of the 35-subject two-part study
will assess the safety of two doses of defibrotide. The second part will
evaluate the safety and efficacy of defibrotide at the recommended dose
for preventing CAR T-associated neurotoxicity. The primary endpoint is
the incidence of said neurotoxicity. The estimated primary completion
date is April 2021.
Defibrotide is mixture of single-stranded
oligonucleotides purified from the intestines of pigs that acts locally
as an anticoagulant and an anti-inflammatory and anti-ischemic agent.
https://seekingalpha.com/news/3505140-enrollment-underway-mid-stage-study-jazz-pharmas-defibrotide
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