BrightPath Biotherapeutics Co.,Ltd. [4594.T]
TOKYO, Mar 31 (Pulse News Wire) – Brightpath Biotherapeutics CO.,LTD. (4594.T) announced today that it has extended the completion deadline for its domestic clinical trial of HER2 CAR-T cell therapy BP-CAR003.
Initially planned to conclude by March 31, 2026, the trial now faces delays due to ongoing adjustments in reagents used for quality testing of cell products post-manufacture but pre-administration. Discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) led to changes that temporarily halted patient enrollment. While recruitment has resumed, the final case study cannot be completed within the initial timeframe.
The company noted that while manufacturing issues have been rare for BP-CAR003, recent adjustments in reagent protocols delayed the necessary quality tests. Despite these challenges, revised procedures have allowed for renewed patient enrollment and administration of modified cell products. However, the precise timeline for completing the final cases remains undetermined.
Regarding financial impact, approximately ¥15 million in costs associated with the manufacture and administration of the final enrolled cases will be deferred to the next fiscal year.
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