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:
- 实现了关键里程碑——美国食品药品管理局接受了CEL-SCI的选择标准，该标准定义了术前Multikine目标人群
- 根据对已完成的928名患者的3期随机对照试验的分析，选定的患者群体使用Multikine的存活率为73％，而没有Multikine的存活率为45％
- 已完成的3期试验（晚期原发性头颈癌中规模最大的试验）的可靠疗效和安全性数据为支持，212名患者的确认性研究已降低风险
- 在此处查看CEL-SCI关于美国食品药品管理局批准和公司为投资者提供的价值主张的综合报告：
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（纽约证券交易所代码：CVM）今天宣布，其最近与美国食品药品监督管理局（FDA）就其一线研究性癌症免疫疗法Multikine*（白细胞介素，注射剂）的批准途径进行了会谈，取得了显著的积极成果。根据CEL-SCI已完成的3期头颈癌研究的强大安全性和有效性数据，美国食品药品管理局表示，CEL-SCI可能会推进对新诊断的晚期原发性头颈癌患者的Multikine注册研究，该患者没有淋巴结受累（通过PET扫描确定），PD-L1 肿瘤表达较低（通过活检确定）。
"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."
“通过与美国食品药品管理局的讨论和协议，对于新诊断患有头颈部癌的人来说，我们已经实现了一个重要的里程碑。目标患者群体的生存益处是如此强大而明显，以至于我们的确认性研究只需要招收212人即可确认在3期研究中已经取得的成果。这为我们提供了明确的前进方向。” CEL-SCI首席执行官海尔特·克尔斯滕说。“我们渴望尽快开始这项研究。”
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发布了一份关于美国食品药品管理局协议和Multikine前进方向的报告。请点击此链接阅读完整报告。亮点包括：