VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced its renewed collaboration with Ergomed Clinical Research for its upcoming U.S. Food and Drug Administration (FDA) confirmatory Registration Study of Multikine® (Leukocyte Interleukin, Injection) in head and neck cancer..

弗吉尼亚州维也纳（商业新闻短讯）--CEL-SCI公司（纽约证券交易所美国代码：CVM）今天宣布与Ergomed临床研究重新合作，以进行即将到来的美国食品和药物管理局（FDA）头颈癌中Multikine®（白细胞白细胞介素，注射液）的验证性注册研究。。

Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of the trial, supporting CEL-SCI in bringing a new treatment option for patients with locally advanced primary head and neck cancer to the market.

Ergomed将提供全球全面的临床操作支持，以确保试验的及时有效执行，支持CEL-SCI为局部晚期原发性头颈癌患者带来新的治疗选择。

This partnership marks a continuation of the successful cooperation between the two companies, building on their previous collaboration for the Phase 3 trial of Multikine, which was the largest study ever conducted in head and neck cancer.

这一合作关系标志着两家公司之间成功合作的延续，这是他们之前在Multikine 3期试验中的合作，这是有史以来在头颈癌方面进行的最大规模的研究。

In addition to the positive outcome from its recent meeting with the FDA regarding the path to approval for its first-line investigational cancer immunotherapy, CEL-SCI achieved other major milestones including receiving pediatric waivers from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA)..

除了最近与FDA就一线研究性癌症免疫疗法的批准途径举行的会议取得了积极成果外，CEL-SCI还取得了其他重大里程碑，包括获得了英国药品和保健品管理局（MHRA）和欧洲药品管理局（EMA）的儿科豁免。。

This confirmatory study represents a crucial step toward potential marketing approval of Multikine. The study, set to enrol 212 newly diagnosed patients with locally advanced primary head and neck cancer, will focus on patients with no lymph node involvement and low PD-L1 tumour expression. Patients will be enrolled across multiple sites globally, underscoring the strength of Ergomed’s global clinical trial management capabilities..

这项验证性研究代表了Multikine潜在市场批准的关键一步。这项研究将招募212名新诊断的局部晚期原发性头颈癌患者，重点关注无淋巴结受累和PD-L1肿瘤表达低的患者。患者将在全球多个地点注册，突显了Ergomed全球临床试验管理能力的优势。。

Geert Kersten, CEO of CEL-CI commented, “Ergomed is a trusted partner. Our past experience taught us that they are highly competent and motivated. Their enrolment was fast and the study was clean. The plan is for the study to commence in Q1 2025 in multiple countries.”

CEL-CI首席执行官Geert Kersten评论道：“Ergomed是一个值得信赖的合作伙伴。我们过去的经验告诉我们，他们非常有能力和积极性。他们的入学速度很快，学习也很干净。计划在2025年第一季度在多个国家开始这项研究。”

Dr. Sy Pretorius, CEO of Ergomed Group, added, 'We are excited to once again partner with CEL-SCI on this significant trial for Multikine. Our prior collaboration has set a strong foundation for this new phase, and we are committed to leveraging our global expertise in oncology clinical research to support this critical confirmatory study.

Ergomed Group首席执行官Sy Pretorius博士补充道，“我们很高兴再次与CEL-SCI合作进行这项针对Multikine的重要试验。我们之前的合作为这一新阶段奠定了坚实的基础，我们致力于利用我们在肿瘤学临床研究方面的全球专业知识来支持这项关键的验证性研究。

Together, we aim to advance innovative therapies that can make a real impact on patients' lives.'.

我们共同致力于推进能够对患者生活产生真正影响的创新疗法。

Multikine has already demonstrated promising results in its prior studies, showing a significant improvement in survival rates. In the target population for the confirmatory study, patients treated with Multikine had a 5-year survival of 73% vs 45% survival in the control patients, with a hazard ratio of 0.35.

Multikine在其先前的研究中已经显示出有希望的结果，显示存活率显着提高。在验证性研究的目标人群中，接受多因子治疗的患者的5年生存率为73%，而对照组患者的生存率为45%，风险比为0.35。

The confirmatory study is designed to provide the final data required for regulatory approval, bringing Multikine one step closer to becoming a breakthrough treatment option for head and neck cancer patients worldwide..

验证性研究旨在提供监管部门批准所需的最终数据，使Multikine更接近成为全球头颈癌患者的突破性治疗选择。。

About CEL-SCI Corporation

关于CEL-SCI公司

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system 'target' the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor..

。Multikine旨在帮助免疫系统在免疫系统相对完整的时候“靶向”肿瘤，从而被认为能够更好地攻击肿瘤。。

Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs.

多因子（白细胞介素，注射液）是一种真正的一线癌症治疗药物，已在740多名患者中服用，并获得了FDA的孤儿药指定，用于头颈部鳞状细胞癌（癌症）患者的新辅助治疗。Multikine显着延长了其目标患者人群的寿命，表明Multikine vs.的生存率为73%。

only 45% without Multikine at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced primary head and neck cancer patients who present with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients (globally) annually..

治疗后5年只有45%没有多因子。基于这一非常有力的数据，FDA同意CEL-SCI的目标患者选择标准，并同意进行一项小型，重点明确的确认性登记研究，该研究将招募212名患者。CEL-SCI将招募新诊断的局部晚期原发性头颈癌患者，这些患者无淋巴结受累（通过PET扫描确定），PD-L1肿瘤表达低（通过活检确定），每年代表100000多名患者（全球）。。

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

该公司在弗吉尼亚州维也纳和马里兰州巴尔的摩附近/有业务。

About Ergomed

关于Ergomed

Founded in 1997, Ergomed supports pharmaceutical companies with services spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Recognized internationally in both rare disease and oncology drug development for its expertise, Ergomed offers a full range of quality clinical research and clinical trial management services along with an industry-leading suite of specialized pharmacovigilance solutions.

Ergomed成立于1997年，为制药公司提供跨越临床试验、批准后药物警戒和医疗信息各个阶段的服务。Ergomed凭借其专业知识在罕见病和肿瘤药物开发方面获得国际认可，它提供全方位的优质临床研究和临床试验管理服务，以及业界领先的一套专业药物警戒解决方案。

By providing this full-service offering, Ergomed enables emerging and established life sciences companies to meet their regulatory obligations, maximize their drug development success and their product value. For more information: info@ergomedgroup.com..

通过提供这种全方位服务，Ergomed使新兴和成熟的生命科学公司能够履行其监管义务，最大限度地提高其药物开发成功率和产品价值。有关更多信息：info@ergomedgroup.com..

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words 'intends,' 'believes,' 'anticipated,' 'plans' and 'expects,' and similar expressions, are intended to identify forward-looking statements.

本新闻稿包含经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的前瞻性声明。在本新闻稿中使用“意图”、“相信”、“预期”、“计划”和“期望”等词语以及类似的表达方式，旨在识别前瞻性陈述。

Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023.

此类报表存在风险和不确定性，可能导致实际结果与预测结果产生重大差异。可能导致或促成这种差异的因素包括无法复制临床研究中证明的临床结果，及时开发任何可以证明安全有效的潜在产品，获得必要的监管批准，制造公司任何潜在产品的困难，无法筹集必要的资金以及CEL-SCI向证券交易委员会提交的文件中不时列出的风险因素，包括但不限于其截至2023年9月30日的10-K表格报告。

The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events..

公司没有义务公开发布这些前瞻性声明的任何修订结果，这些修订可能是为了反映本协议日期后的事件或情况或反映意外事件的发生。。

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency.

*Multikine（白细胞白细胞介素，注射液）是CEL-SCI为该研究疗法注册的商标。该专有名称须经FDA审查，并与公司未来预期的监管提交审批相关。Multikine尚未获得FDA或任何其他监管机构的销售、易货或交换许可或批准。

Similarly, its safety or efficacy has not been established for any use..

同样，其安全性或有效性尚未确定用于任何用途。。