スリー・ディー・マトリックス---吸収性局所止血材(TDM-621)の国内での治験開始

2017年08月09日 13:33:00
マネー
FISCO
コメント

スリー・ディー・マトリックス<7777>は8日、自己組織化ペプチド技術を用いた吸収性局所止血材(TDM-621)に関して、国内の治験実施施設において第1例目の症例登録を実施し、治験を開始したと発表。

医療機器として治験計画届を2017年4月11日付で独立行政法人医薬品医療機器総合機構(PMDA)に提出し、治験開始の手続きを進めていた。消化器内視鏡的治療(内視鏡的に使用可能な高周波メスを使って、粘膜下層のレベルで病変を剥がし取る手技)において、TDM-621の有効性を従来の止血法との比較を実施する治験を開始した。

治験期間は約1年で終了を予定。治験終了後にはPMDAに製造販売承認申請をする。またTDM-621に関して扶桑薬品工業<4538>と国内における独占販売権許諾契約を締結しており、製造販売承認取得後に製品販売を計画している。

TDM-621は、人体の構成成分である3種のアミノ酸から成るペプチドを原料とした透明な液体で、血液に触れると瞬時にハイドロゲルを形成する特性(自己組織化)により、血管断面を物理的に塞いで止血を行う。

＜MW＞

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