Jazz Pharmaceuticals is set to initiate a single-arm, pivotal Phase II/III study of JZP-458 as a potential treatment option for acute lymphoblastic leukaemia (ALL) or lymphoblastic lymphoma (LBL) patients.
The company previously reported positive results from the Phase I study of the recombinant crisantaspase molecule, JZP-458. The study met its efficacy and safety objectives.
The study was conducted in healthy volunteers in the US, with the efficacy being based on the measurement of serum asparaginase activity levels.
Jazz Pharmaceuticals Research and Development executive vice-president Robert Iannone said: “Jazz is committed to the ALL patient community, and we are pleased to advance this development programme with the goal of bringing a new treatment option to ALL and LBL patients who are hypersensitive to E. coli-derived asparaginase products as soon as possible.
“Following a meeting with the US Food and Drug Administration, we are finalising the Phase II/III study protocol in collaboration with the Children’s Oncology Group and plan to initiate the study later this year.”
JZP-458 uses a novel Pseudomonas fluorescens expression platform and is being developed for use as a component of a multi-agent chemotherapeutic regimen to treat pediatric and adult patients with ALL or LBL.
ALL is a cancer of the blood and bone marrow that can progress quickly if left untreated.
According to the American Cancer Society estimations, almost 6,000 new cases of ALL will be diagnosed in the US this year.
Last November, Jazz Pharmaceuticals enrolled the first patient in a Phase III clinical trial to assess the efficacy and safety of JZP-258 to treat idiopathic hypersomnia.
The double-blind, placebo-controlled, randomised-withdrawal trial aims to enrol around 140 adult patients.