-- BriaCell Therapeutics（BCT.TO）は、転移性乳がんに対する次世代細胞免疫療法の臨床試験開始について、米国食品医薬品局（FDA）の承認を取得したと、水曜日に発表した。 新たな免疫療法を開発している同社は、FDAが治験薬申請（IND）を承認したことで、臨床効果を高めるために免疫活性化成分を追加したBria-BRES+の第1/2a相臨床試験を開始できるようになったと述べた。 Bria-BRES+は、乳がん臨床プログラムであるBria-OTSの成果に基づいている。Bria-OTSでは、最初の投与を受けた患者において肺転移の完全寛解が持続的に認められた。この患者はBria-OTSを17サイクル投与され、12ヶ月間の試験を完了し、現在も生存追跡調査を受けていると、同社は声明で述べた。 「次世代個別化免疫療法であるBria-BRES+の最初のINDがFDAの承認を得たことを光栄に思います」と、最高経営責任者（CEO）のウィリアム・ウィリアムズ氏は述べた。 「Bria-BRES+の独自の設計は、転移性乳がんにおいて良好な安全性プロファイルと有意義な治療効果をもたらす可能性を秘めています。有効な治療選択肢がほとんど、あるいは全くないこれらの患者さんに新たな希望をもたらすべく、Bria-BRES+の臨床試験への移行を進めていくことを楽しみにしています。」 BriaCellの株価は、ニューヨーク市場で0.02ドル安の4.05ドルで取引を終えました。
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