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シンバイオ製薬---注射剤ブリンシドフォビルによる第2a相臨床試験においてFPI(第1例目)を達成

Shin-Bio Pharmaceuticals achieved FPI (first patient in) in the Phase 2a clinical trial of the injection Brincidofovir.

Fisco Japan ·  Jun 12 09:28

On June 10th, 2024 (Central Time in the US), the first case was registered in the phase 2a clinical trial of the injection Brincidofovir (BCV) for cytomegalovirus infection (CMV) after hematopoietic stem cell transplantation (HSCT) underway in the US.

This trial is a protocol amendment of phase 2a trial for immunocompromised patients with adenovirus infection currently underway, which was newly expanded to include CMV infection following its acceptance by the US Food and Drug Administration (FDA) in February of this year.

CMV infection after HSCT has the highest incidence rate of virus infections after HSCT, and while there are already preventive or therapeutic drugs available, there are many cases of reactivation, resistance, and non-response, and the number of patients is large. It is a highly infectious disease with a high medical need in an unsatisfied therapeutic area.

Chimerix has already obtained promising results in the clinical trial of oral BCV for CMV infection, and now they will begin a clinical trial using the safe injection BCV that is expected to demonstrate high efficacy against CMV infection.

The translation is provided by third-party software.


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