ATLANTA--(BUSINESS WIRE)--Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced that it is partnering with Massachusetts General Hospital as its contract research organization (“CRO”) to conduct first of its kind Phase II clinical study of AL001 for treatment of patients with PTSD.

亚特兰大--（商业新闻短讯）--Alzamend Neuro，Inc.（纳斯达克代码：ALZN）（“Alzamend”），一家临床阶段生物制药公司，专注于开发治疗阿尔茨海默病（“阿尔茨海默病”）、躁郁症（“BD”）、重性抑郁障碍（“MDD”）和创伤后应激障碍（“PTSD”）的新产品，今天宣布，它正在与马萨诸塞州总医院合作，作为其合同研究组织（“CRO”），进行AL001的首次II期临床研究，用于治疗PTSD患者。

Massachusetts General Hospital is the original and largest clinical education and research facility of Harvard Medical School/Harvard University and houses the world's largest hospital-based research program..

马萨诸塞州总医院是哈佛医学院/哈佛大学最初也是最大的临床教育和研究机构，拥有世界上最大的基于医院的研究项目。。

Alzamend and Mass General have contracted with Dr. Ovidiu Andronesi, MD, PhD, to be the principal investigator on the study. Dr. Andronesi is an Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging, Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital..

Alzamend和Mass General已与医学博士Ovidiu Andronesi博士签约，担任该研究的首席研究员。Andronesi博士是哈佛大学放射学副教授，马萨诸塞州总医院放射科Martinos生物医学成像中心多核代谢成像主任。。

Lithium was the first mood stabilizer approved by the U.S. Food and Drug Administration (“FDA”) and is still a first-line treatment option (considered the “gold standard”) for BD. Moreover, lithium has been marketed for more than 35 years and human toxicology regarding its use has been well characterized, potentially mitigating the regulatory burden for safety data.

锂是美国食品和药物管理局（“FDA”）批准的第一种情绪稳定剂，仍然是BD的一线治疗选择（被认为是“金标准”）。此外，锂已经上市35多年，其使用的人体毒理学已经得到了很好的表征，有可能减轻安全数据的监管负担。

Although lithium does not have an FDA-approved indication for PTSD, case reports suggest that lithium treatment may be useful for treating PTSD patients. In particular, treatment with low doses (300–600 mg/day) of lithium carbonate have been reported to provide effective treatment in reduction of inappropriate anger, irritability, anxiety, and insomnia in those patients.

尽管锂没有FDA批准的PTSD适应症，但病例报告表明，锂治疗可能对治疗PTSD患者有用。。

The clinical observation of mood swings beyond the normal range, but milder than those associated with BD, reportedly suggested the presence of a sub-threshold mood disorder in these PTSD patients. It has also been proposed that treatment of trauma with lithium to forestall the development of PTSD may be provided by pharmacological induction of a mild transient amnesia..

据报道，对情绪波动的临床观察超出了正常范围，但比与BD相关的情绪波动要轻，这表明这些创伤后应激障碍患者存在亚阈值情绪障碍。也有人提出，用锂治疗创伤以预防创伤后应激障碍的发展可以通过药理学诱导轻度短暂性遗忘来提供。。

The objective of this novel trial is to assess the comparative increase in lithium levels within the brain and its structures as opposed to a commonly marketed lithium salt among PTSD patients. By examining the lithium content in the brains and brain structures of patients during treatments, Alzamend aims to predict the minimum dose necessary to achieve the equivalent effectiveness and safety of AL001 in contrast to established lithium salts.

这项新试验的目的是评估PTSD患者大脑及其结构中锂水平的相对增加，而不是通常市售的锂盐。通过检查治疗期间患者大脑和大脑结构中的锂含量，Alzamend旨在预测与已建立的锂盐相比，达到AL001等效有效性和安全性所需的最小剂量。

Alzamend is optimistic that this study will assist in meeting the regulatory safety standards through the Section 505(b)(2) pathway for approval by the U.S. Food and Drug Administration, which is specifically designed for new formulations/ delivery systems of an approved drug..

Alzamend乐观地认为，这项研究将有助于通过第505（b）（2）节途径达到监管安全标准，以获得美国食品和药物管理局的批准，该途径专门针对已批准药物的新配方/递送系统而设计。。

Alzamend previously completed a Phase IIA multiple ascending dose clinical trial, in which it successfully identified a maximum tolerated dose (“MTD”) for development of AL001, as assessed by an independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”).

Alzamend之前完成了一项IIA期多剂量递增临床试验，根据独立安全审查委员会的评估，该试验成功确定了AL001开发的最大耐受剂量（“MTD”）。该剂量每天三次以240毫克的碳酸锂当量剂量提供锂，不太可能需要锂治疗药物监测（“TDM”）。

Current FDA-approved lithium salts (carbonate and citrate) are limited by a narrow therapeutic window that requires regular TDM of plasma lithium levels and blood chemistry by a clinician to mitigate adverse events. Since conventional lithium salts are eliminated relatively quickly, multiple administrations throughout the day are required to safely reach therapeutic plasma concentrations.

目前FDA批准的锂盐（碳酸盐和柠檬酸盐）受到狭窄的治疗窗口的限制，该窗口需要临床医生定期对血浆锂水平和血液化学进行TDM，以减轻不良事件。由于常规锂盐的消除相对较快，因此需要全天多次给药才能安全达到治疗性血浆浓度。

Existing lithium drugs suffer from chronic toxicity, poor physicochemical properties, and poor brain bioavailability. However, because lithium is so effective, it is still used clinically despite its narrow therapeutic index..

现有的锂药物具有慢性毒性，较差的理化性质和较差的大脑生物利用度。然而，由于锂非常有效，尽管其治疗指数很窄，但仍在临床上使用。。

“We are elated to partner with Massachusetts General Hospital and Dr. Andronesi in this pivotal study for our lead therapeutic candidate AL001,” said Stephan Jackman, Chief Executive Officer of Alzamend. “If we can develop a next-generation lithium product (AL001) with an improved safety profile and enhanced biodistribution in the brain that would not routinely require TDM, it would constitute a major improvement over current lithium-based treatments and positively impact the 9+ million Americans afflicted with PTSD.

Alzamend首席执行官斯蒂芬·杰克曼（StephanJackman）表示：“我们很高兴能与马萨诸塞州总医院（MassachusettsGeneral Hospital）和安德罗尼西（Andronesi）博士合作，为我们的主要治疗候选人AL001进行这项关键性研究。”。“如果我们能够开发出一种新一代锂产品（AL001），它具有改进的安全性和增强的大脑生物分布，而不需要常规的TDM，它将对目前的锂基治疗产生重大改进，并对900多万患有创伤后应激障碍的美国人产生积极影响。

We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”.

我们期待在不久的将来提供有关该研究时间表和市场机会的更多详细信息。”。

About AL001

关于AL001

AL001 is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend’s completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s patients and healthy subjects identified an MTD, as assessed by an independent safety review committee.

AL001是一种新型锂输送系统，有可能提供市售锂盐的益处，同时减轻或避免目前与锂相关的毒性。Alzamend在阿尔茨海默病患者和健康受试者中完成的AL001 IIA期多剂量递增研究的结果确定了MTD，由独立安全审查委员会评估。

This MTD is designed to be unlikely to require TDM while providing lithium at a relatively modest but effective dose. AL001 is designed to favorably distribute lithium in the brain resulting in lower exposure of other body organs and an improved safety profile compared to currently marketed lithium salts.

这种MTD的设计不太可能需要TDM，同时以相对适中但有效的剂量提供锂。与目前市场上销售的锂盐相比，AL001旨在有利地将锂分配到大脑中，从而减少其他身体器官的暴露，并提高安全性。

This can serve to mitigate or obviate the disadvantageously low ceiling for toxicity of marketed lithium salts that has limited their usefulness to patients and prescribers..

这可以用来减轻或消除市售锂盐毒性的不利下限，这限制了它们对患者和处方者的有用性。。

About Alzamend Neuro

关于Alzamend Neuro

Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate and L-proline, and ALZN002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s by removing beta-amyloid from the brain.

Alzamend Neuro是一家临床阶段的生物制药公司，专注于开发治疗阿尔茨海默氏病，BD，MDD和创伤后应激障碍的新产品。我们的使命是快速开发和销售安全有效的治疗方法。。

The latter is a second-generation active-immunity approach designed to mitigate the disadvantages of approved passive immunity marketed antibody products, particularly by reducing the required frequency and costs of dosing associated with antibody products. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc.

后者是第二代主动免疫方法，旨在减轻经批准的被动免疫市售抗体产品的缺点，特别是通过降低与抗体产品相关的给药频率和成本。我们的两个候选产品均获得南佛罗里达大学研究基金会的许可。

pursuant to royalty-bearing exclusive worldwide licenses..

根据全球独家许可使用费。。

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. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions.

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”。这些前瞻性陈述通常包括具有预测性的陈述，这些陈述取决于或涉及未来的事件或条件，包括“相信”、“计划”、“预期”、“项目”、“估计”、“期望”、“打算”、“战略”、“未来”、“机会”、“可能”、“将会”、“应该”、“可能”、“潜在”或类似的表达。

Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events.

非历史事实的陈述是前瞻性陈述。前瞻性陈述基于当前的信念和假设，这些信念和假设具有风险和不确定性。前瞻性声明仅在发布之日起生效，Alzamend没有义务根据新信息或未来事件公开更新任何声明。

Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission.

由于各种因素的影响，实际结果可能与任何前瞻性声明中包含的结果存在重大差异。Alzamend向美国证券交易委员会提交的文件中包含了更多可能影响Alzamend业务和财务业绩的信息，包括潜在风险因素。

All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com..

所有文件均可在www.sec.gov和Alzamend的网站www.Alzamend.com上查阅。。