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AIM ImmunoTech Inc.的Ampligen药物被FDA授予胰腺癌治疗孤儿药地位

Written by Customer Service on . Posted in Public Companies.

佛罗里达州奥卡拉, Dec. 22, 2020 (GLOBE NEWSWIRE) — 专注于免疫紊乱、病毒性疾病和多种癌症治疗药物研发的免疫制药公司AIM ImmunoTech Inc.（NYSE American: AIM）今天宣布，美国食品和药物管理局于2020年12月17日授予AIM公司的Ampligen（rintatolimod）胰腺癌治疗孤儿药认定地位。
孤儿药认定程序为用于治疗、预防和诊断罕见疾病或病况的药物和生物制剂授予孤儿药地位。罕见病是在指在美国发病率不到20万分之一或满足法案中成本回收规定的病症。孤儿药地位让公司在药物上市后七年内保持独家权利，从而鼓励开发治疗方法来应对未得到满足的医疗需求。根据胰腺癌行动网络（Pancreatic Cancer Action Network）的数据，胰腺癌是美国第四大癌症致死原因，也是最常见癌症中五年存活率仅为6%的唯一的一种癌症。AIM最近宣布，荷兰伊拉斯姆斯大学医学中心开展的一项多年早期药物获得项目取得了具有统计学意义的胰腺癌阳性生存结果。与匹配年龄、性别、疾病分期和Folfirinox治疗周期指标的历史对照组相比，Ampligen组的总体生存中位值大约高出两倍，即200%。AIM首席执行官Thomas K. Equels表示：“该研究数据表明，与传统的胰腺癌标准治疗方法相比，Ampligen有可能显著提高胰腺癌患者的生存率”。关于AIM ImmunoTech Inc.AIM ImmunoTech Inc.是一家免疫药物公司，致力于研究和开发治疗多种类型癌症、免疫疾病和病毒性疾病（包括由SARS-CoV-2病毒引起的新冠肺炎）的方法。警示声明本新闻稿载有1995年《私人证券诉讼改革法案》（即：PSLRA）所定义的“前瞻性声明”。诸如“可能”、“将会”、“预期”、“计划”、“预计”等词语和类似表达（以及提及未来事件或情况的其他词语或表达）旨在标示前瞻性声明。这些前瞻性声明中有许多涉及多项风险和不确定性。除其他事项外，我们还要求对上述声明给予PSLRA中所规定的前瞻性声明安全港保护。我们不承诺对该等前瞻性陈述进行更新以反映本协议日期之后发生的事件或情况。伊拉斯姆斯大学研究的统计分析基于Ampligen治疗组患者与特征相似的历史对照组患者的对比，其中对照组患者以前接受过胰腺癌治疗，但未接受Ampligen治疗。由于不是同期对照，Ampligen治疗的分配并非随机，也不对研究人员或患者设盲。要确定Ampligen在人类胰腺癌治疗中是否有效，还需要进行大量其他测试和试验，且无法保证事实将会如此。目前尚不能保证欧洲药品局会批准孤儿药认定。此外，对于未来的胰腺免疫肿瘤学临床试验能否成功或产生有利数据无法作出任何保证，试验受到许多因素影响，包括无法获得监管批准、缺乏研究药物，或申办其他试验的机构中优先事项发生变化。此外，我们认识到各癌症中心和所有医疗机构一样，必须将当前的新冠肺炎疫情作为优先事项。因此，鉴于冠肺炎紧急医疗情况，癌症患者目前和未来研究的临床试验招募和报告可能会出现延误。无法保证未来研究不会得出与上述报告中不同的结果。海外运营涉及很多风险，包括在执行知识产权方面的潜在困难。我们无法保证潜在的海外业务不会受到这些风险的不利影响。联系方式：Crescendo Communications, LLC
电话：212-671-1021
电子邮箱：aim@crescendo-ir.comAIM ImmunoTech Inc
电话：800-778-4042
电子邮箱：IR@aimimmuno.com本通告随附图片请见 https://www.globenewswire.com/NewsRoom/AttachmentNg/8832a6e4-76b4-420a-ab67-566b0fa97651

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