CEL-SCI Receives FDA Approval For Its Confirmatory Study Of Multikine For The Treatment Of Head & Neck Cancer
CEL-SCI Receives FDA Approval For Its Confirmatory Study Of Multikine For The Treatment Of Head & Neck Cancer
- Critical milestone achieved—the FDA accepted CEL-SCI's selection criteria defining the Multikine target population before surgery
- Selected patient population had 73% survival with Multikine vs. 45% without Multikine based on analysis of completed 928-patient Phase 3 randomized controlled trial
- 212-patient confirmatory study is de-risked, backed by robust efficacy and safety data from completed Phase 3 trial, the largest in advanced primary head and neck cancer
- View CEL-SCI's comprehensive report regarding the FDA's go-ahead and the Company's value proposition for investors here:
- 實現了關鍵里程碑——美國食品藥品管理局接受了CEL-SCI的選擇標準，該標準定義了術前Multikine目標人群
- 根據對已完成的928名患者的3期隨機對照試驗的分析，選定的患者群體使用Multikine的存活率爲73％，而沒有Multikine的存活率爲45％
- 已完成的3期試驗（晚期原發性頭頸癌中規模最大的試驗）的可靠療效和安全性數據爲支持，212名患者的確認性研究已降低風險
- 在此處查看CEL-SCI關於美國食品藥品管理局批准和公司爲投資者提供的價值主張的綜合報告：
CEL-SCI Corporation (NYSE:CVM) today announced a significantly positive outcome from its recent meeting with the U.S. Food and Drug Administration (FDA) regarding the path to approval for its first-line investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection). Based on strong safety and efficacy data from CEL-SCI's completed Phase 3 head and neck cancer study, the FDA indicated CEL-SCI may move forward with a confirmatory Registration Study of Multikine in newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).
CEL-SCI公司（紐約證券交易所代碼：CVM）今天宣佈，其最近與美國食品藥品監督管理局（FDA）就其一線研究性癌症免疫療法Multikine*（白細胞介素，注射劑）的批准途徑進行了會談，取得了顯著的積極成果。根據CEL-SCI已完成的3期頭頸癌研究的強大安全性和有效性數據，美國食品藥品管理局表示，CEL-SCI可能會推進對新診斷的晚期原發性頭頸癌患者的Multikine註冊研究，該患者沒有淋巴結受累（通過PET掃描確定），PD-L1 腫瘤表達較低（通過活檢確定）。
"Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer. The survival benefit was so strong and clear in the target patient population that our confirmatory study needs to enroll only 212 people to confirm what was already achieved in the Phase 3 study. This gives us a clear path forward," stated CEL-SCI CEO, Geert Kersten. "We are eager to begin the study as soon as possible."
“通過與美國食品藥品管理局的討論和協議，對於新診斷患有頭頸部癌的人來說，我們已經實現了一個重要的里程碑。目標患者群體的生存益處是如此強大而明顯，以至於我們的確認性研究只需要招收212人即可確認在3期研究中已經取得的成果。這爲我們提供了明確的前進方向。” CEL-SCI首席執行官海爾特·克爾斯滕說。“我們渴望儘快開始這項研究。”
CEL-SCI published a report on the FDA's agreement and Multikine's path forward. Please click on this link to read the full report. Highlights include:
CEL-SCI發佈了一份關於美國食品藥品管理局協議和Multikine前進方向的報告。請點擊此鏈接閱讀完整報告。亮點包括：
譯文內容由第三人軟體翻譯。