Jazz Enrolls First Patient In Phase II/III Leukemia Study
Zacks Investment Research | Dec 30, 2019 11:05PM ET
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) announced that it has enrolled the first patient in the pivotal phase II/III study evaluating its novel asparaginase JZP-458 as a potential treatment of pediatric and adult patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginases.
In October, the FDA granted a Fast Track designation to JZP-458 for treating the given patient population.
This single-arm, open-label dose confirmation and confirmatory study is being conducted in collaboration with Children's Oncology Group.
Per the company, the study will assess the safety, tolerability and efficacy of JZP-458 in patients with ALL/LBL who have silent inactivation or an allergic reaction to E. coli-derived asparaginases having received no prior asparaginase Erwinia chrysanthemi.
The primary objective of the study is to determine the efficacy of JZP-458 measured by asparaginase activity.
Shares of Jazz have rallied 19.9% in the past year compared with the Zacks Investment Research
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