Servier will be proceeding with the clinical development of cellular therapy intended to treat relapsed or refractory acute lymphoblastic lukemia.
The pharmaceutical company finally gained official Food and Drug Administration (FDA) clearance for the trial to test the investigational new drug, which will be conducted in with the help of Pfizer.
“Pfizer is excited by the potential of this investigational CAR T approach to treating ALL and other B-Cell malignancies,” Barbara Sasu, vice president of CAR T Research at Pfizer, said in a
Pfizer press release. “We are looking forward to having the opportunity to investigate this approach in the U.S.”
In 2015, Serveir obtained exclusive rights for UCART 19 from Cellectics, and the CALM Phase I study began in the United Kingdom in August. The study is designed to evaluate a number of factors, from safety to tolerability to antileukemic activity in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
“We are very pleased that Servier’s first IND approval has been granted for such an innovative approach as allogeneic CAR T therapy," Dr. Patrick Thérasse, director of clinical development oncology at Servier, said. “B-ALL is a devastating disease and this study is key to gaining greater insight into the efficacy and safety profile of this new immune-oncology approach in patients with B-ALL.”
Servier receives FDA clearance for clinical development of lymphoblastic leukemia treatment
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