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FDA Stops Ongoing Trial Exploring Novel Therapy in Pancreatic and Prostate Cancer
Ryan McDonald, Associate Editorial Director for CURE®, has been with the team since February 2020 and has previously covered medical news across several specialties prior to joining MJH Life Sciences. He is a graduate of Temple University, where he studied journalism and minored in political science and history. He considers himself a craft beer snob and would like to open a brewery in the future. During his spare time, he can be found rooting for all major Philadelphia sports teams. Follow Ryan on Twitter @RMcDonald11 or email him at rmcdonald@curetoday.com.
An ongoing phase 1/2 was put on hold by the Food and Drug Administration after the death of a patient with pancreatic cancer.
The Food and Drug Administration (FDA) placed a hold on an ongoing phase 1/2 dose-escalation study of the GoCAR-T product candidate BPX-601 for patients with previously treated metastatic pancreatic or prostate cancer, according to a press release from the product’s manufacturer, Bellicum.
The hold is meant to address a patient death that occurred in the trial, which the clinical investigator and manufacturer are stating is unrelated to BPX-601 and another agent rimiducid.
The manufacturer stated it plans to work closely with the agency to address any of its questions and fulfill the necessary requirements to resume the trial.
BPX-601 is a GoCAR-T product candidate that incorporates inducible MyD88/CD40 (iMC), which is designed to help increase the production and persistence of T cells, as well as the production of immunomodulatory cytokines that enable the CAR-T to override any mechanisms inhibiting immune response.
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