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FDA grants clearance for trial of TZ 101 in children with hematologic malignancies
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The FDA granted investigational new drug clearance for a phase 2 study of TZ 101-fucosylated hematopoietic stem cell transplants for children with hematologic malignancies, according to the agent’s manufacturer.
TZ101 (Targazyme) is a patented, enzyme-based treatment used at the point-of-care to treat therapeutic cells immediately before infusion into patients.
The clearance allows for enrollment of patients for a phase 2 of children with cancer who undergo single cord-blood transplant.
“This FDA investigational new drug clearance ... is an important clinical milestone to help us drive toward our initial target product label of 'reduction in opportunistic infections and graft-versus-host disease post–hematopoietic stem cell transplantation' for both pediatric and adult cancer patients,” Lynnet Koh, CEO of Targazyme, said in a company-issued press release.
Researchers at The University of Texas MD Anderson Cancer Center previously conducted a phase 2 trial designed to evaluate TZ101 in adults with leukemia, lymphoma and myelodysplastic syndrome.
The treatment exhibited “a good safety profile and promising efficacy outcomes in terms of time to neutrophil and platelet recovery with additional positive signals in stem cell engraftment rate, reduction in chronic GVHD and OS in adult cancer patients,” Joseph Rosenthal, MD, MHCM, chair of pediatrics at City of Hope, said in the release.
“Successful replication of these results in the single cord-blood transplant setting in pediatric cancer patients may lower the rate of opportunistic infections, reduce the incidence of chronic GVHD, and reduce morbidity, mortality and hospitalization for kids undergoing this life-saving procedure through the use of TZ 101,” Rosenthal added.