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FINWIRES

アロジェン・セラピューティクス社、韓国とオーストラリアでB細胞リンパ腫治療試験の拡大を承認される

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-- アロジェン・セラピューティクス(ALLO)は火曜日、大細胞型B細胞リンパ腫患者に対する一次治療としてのセマカブタゲン・アンセゲドリューセルの有効性を評価する第2相臨床試験を、韓国とオーストラリアの規制当局から承認を得たと発表した。 同社によると、今回の承認により、試験実施施設は現在北米の60カ所以上から、世界80カ所以上に拡大される予定だ。 声明によると、試験には2027年末までに約220名の患者が登録される見込みで、無イベント生存期間の中間解析は2027年半ば、主要解析は2028年半ばに実施される予定だ。 アロジェンは、試験で良好な結果が得られれば、生物製剤承認申請(BLA)の提出を後押しできる可能性があるとしている。

Price: $2.31, Change: $-0.12, Percent Change: -4.75%

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