Phase 1 Clinical Trials of the Hemopurifier® Designed to Include Patients With Solid Tumors Who Have Stable or Progressive Disease During Anti-PD-1 Monotherapy Treatment, Such as Keytruda® of Opdivo®

HemoPurizer®的第一阶段临床试验旨在包括在抗PD-1单一疗法治疗期间患有稳定或进行性疾病的实体瘤患者，例如Opdivo®的Keytruda®

Interested Clinical Sites Have Initiated Submissions For Ethics Committee Review

感兴趣的临床网站已开始提交伦理委员会审查

SAN DIEGO, June 3, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today provided the following update on its planned phase 1 safety, feasibility and dose-finding clinical trials of its Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®..

圣地亚哥，2024年6月3日/PRNewswire/--Aethlon Medical，Inc.（纳斯达克：AEMD），一家专注于开发治疗癌症和威胁生命的传染病产品的医疗治疗公司，今天提供了其计划的第一阶段安全性，可行性和剂量发现临床试验的最新信息，该试验针对在抗PD-1单一疗法治疗期间病情稳定或进展的实体瘤患者，如Keytruda®或Opdivo®。。

'We continue to make progress preparing for our planned, safety, feasibility and 'dose finding' oncology trials in Australia and India, and want to provide our shareholders and other constituents with an update, stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. In early May, we announced new data showing the in vitro removal of exosomes from cancer patient plasma using a miniature version of our Hemopurifier®.

Aethlon Medical首席医疗官史蒂文·拉罗萨（Steven LaRosa）医学博士表示：“我们继续在为澳大利亚和印度的计划性，安全性，可行性和“剂量发现”肿瘤学试验做准备，并希望为我们的股东和其他参与者提供最新信息。5月初，我们宣布了新的数据，显示使用微型版本的HemoPurizer®从癌症患者血浆中体外去除外泌体。

This data has been quickly integrated into the required documentation for Ethics Committees at our potential clinical sites. On May 17, 2024, we provided these documents to the Contract Research Organizations for these planned clinical trials. Subsequently, on May 24, 2024, one potential site submitted the documents to its Ethics Board.

这些数据已迅速整合到我们潜在临床地点伦理委员会所需的文件中。2024年5月17日，我们为这些计划的临床试验向合同研究组织提供了这些文件。随后，2024年5月24日，一个潜在网站向其道德委员会提交了这些文件。

An additional site in Australia and another in India are currently assembling the packages for submission to their Ethics Committees..

澳大利亚和印度的另外一个网站目前正在组装这些软件包，以提交给他们的道德委员会。。

Once we receive the expected Ethics Committee approvals, we will finalize the Clinical Trial Agreements. After this, hospitals can begin recruiting patients for the trials.

一旦我们获得预期的伦理委员会批准，我们将最终确定临床试验协议。在此之后，医院可以开始招募患者进行试验。

As a reminder, the target patient population for these safety, feasibility, and dose finding trials is oncology patients with solid tumors who are failing their anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.

提醒一下，这些安全性，可行性和剂量发现试验的目标患者人群是实体瘤肿瘤患者，他们的抗PD-1单一疗法治疗失败，如Keytruda®或Opdivo®。

About Aethlon and the Hemopurifier®Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology.

关于Aethlon和HemoPurizer®Aethlon Medical是一家专注于开发HemoPurizer的医疗公司，HemoPurizer是一种临床阶段免疫治疗设备，旨在对抗癌症和危及生命的病毒感染，并用于器官移植。在人体研究中，血液净化器已经证明可以去除危及生命的病毒，在临床前研究中，血液净化器已经证明可以利用其专有的基于凝集素的技术从生物体液中去除有害的外泌体。

This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease.

这种作用在癌症中具有潜在的应用，外泌体可能促进免疫抑制和转移，以及威胁生命的传染病。血液净化器是美国食品和药物管理局（FDA）指定的突破性设备，用于治疗对标准治疗无反应或不耐受的晚期或转移性癌症患者，以及已显示外泌体参与疾病发展或严重程度的癌症类型。

The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies..

血液净化器还拥有FDA突破性的设备名称和开放式研究设备豁免（IDE）应用程序，与未经批准的治疗方法解决的威胁生命的病毒的治疗有关。。

Additional information can be found at www.AethlonMedical.com.

有关更多信息，请访问www.AethlonMedical.com。

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as 'may,' 'believe,' 'anticipate,' 'expect,' 'intend,' 'plan,' 'project,' 'will,' 'projections,' 'estimate,' 'potentially' or similar expressions constitute forward-looking statements.

前瞻性声明本新闻稿包含1933年《证券法》第27A节和1934年《证券交易法》第21E节所指的涉及风险和不确定性的前瞻性声明。包含诸如“可能”、“相信”、“预期”、“期望”、“打算”、“计划”、“计划”、“意志”、“预测”、“估计”、“潜在”或类似表达的语句构成前瞻性语句。

Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect.

此类前瞻性陈述存在重大风险和不确定性，实际结果可能与前瞻性陈述中预期的结果存在重大差异。这些前瞻性陈述基于Aethlon目前的预期，并涉及可能永远不会实现或可能被证明不正确的假设。

Factors that may contribute to such differences include, without limitation, the Company's ability to successfully complete development of the Hemopurifier and to successfully demonstrate the utility of the Hemopurifier in patients with solid tumors in our planned oncology clinical trials,  the Company's ability to obtain the approval by the respective Ethics Boards of interested clinical trial sites in India and in Australia, the Company's ability to recruit patients for and manage its clinical trials, and other potential risks.

可能导致这种差异的因素包括但不限于，公司成功完成血液净化器开发的能力，以及在我们计划的肿瘤临床试验中成功证明血液净化器在实体瘤患者中的实用性，公司获得印度和澳大利亚感兴趣的临床试验地点各自伦理委员会批准的能力，公司招募患者并管理其临床试验的能力以及其他潜在风险。

The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption 'Risk Factors' in the Company's Annual Report on Form 10-K for the year ended March 31, 2023, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q.

上述风险和不确定性列表是说明性的，但并非详尽无遗。可能导致结果与前瞻性报表中预期结果产生重大差异的其他因素，可以在公司截至2023年3月31日的10-K表年度报告以及公司向证券交易委员会提交的其他文件（包括10-Q表季度报告）中的“风险因素”标题下找到。

All fo.

所有fo。

Company Contact:Jim FrakesInterim Chief Executive Officer and Chief Financial OfficerAethlon Medical, Inc. Jfrakes@aethlonmedical.com

公司联系人：Jim Frakesmim首席执行官兼首席财务官Ceraethlon Medical，Inc。Jfrakes@aethlonmedical.com

Investor Contact:Susan NoonanS.A. Noonan Communications, LLCsusan@sanoonan.com917-513-5303

投资者联系人：苏珊·诺南。A、 努南通信公司，LLCsusan@sanoonan.com917-513-5303

SOURCE Aethlon Medical, Inc.

来源：Aethlon Medical，Inc。