Reports Interim Phase I/IIa Trial Results for TZ101, a Novel Enzyme Treatment to Enhance Stem Cell Targeting/Engraftment for Improved Cancer Patient Clinical Outcomes
Phase I/IIa results of Targazyme’s lead product, TZ101, were presented at the
Results from 16 patients (20 treated to date) show that TZ101 has a good safety profile. There were no observed infusion-related adverse events nor were there adverse events considered related to TZ101. Furthermore, the rate of acute graft versus host disease was similar to historical controls.
For the primary efficacy endpoints, treatment of cord blood with TZ101 led to (1) a reduction in the time to neutrophil recovery with a median of 15 days compared to historical matched control value of 24 days, (2) a reduction in the time to platelet recovery with a median of 35 days compared to historical matched control value of 49 days, and (3) a cumulative incidence of neutrophil and platelet engraftment of 94%.
“Enhancing umbilical cord stem cell engraftment into bone marrow in the dual cord transplant setting will lead to improved clinical outcomes for patients with serious, life-threatening cancers and other disorders for which hematopoietic stem cell transplant is prescribed,” said Dr. Shpall.
“Targazyme was founded with the vision to make stem cell transplants safer and more efficacious for patients undergoing cell therapy, starting with cancer patients. This interim Phase I/IIa human proof of concept patient data demonstrates the potential of Targazyme’s enzyme therapies to transform outcomes for cancer patients undergoing hematopoietic stem cell transplantation. This may translate to additional applications in the fields of immunotherapy and regenerative medicine,” said
Targazyme's lead product, TZ101 (formerly ASC-101), is a kit consisting of an enzyme (fucosyltransferase VI) and its substrate (GDP-fucose), which has received orphan drug designation from the
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