Completion of enrollment of study on track by end of 2023

到2023年底完成研究报名

Topline data results from interim analysis also on track to announce by end of 2023

中期分析的顶线数据结果也在轨道上，到2023年底公布

HOUSTON, TX / ACCESSWIRE / September 7, 2023 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ('CNS' or the 'Company'), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that 200 of the expected 243 patients have now been enrolled in the Company's ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer..

德克萨斯州休斯顿/ACCESSWIRE/2023年9月7日/CNS制药公司（纳斯达克股票代码：CNSP）（'CNS'或'公司'），一家生物制药公司，专门为原发性和转移性癌症开发新的治疗方法。大脑和中枢神经系统，今天宣布，预计的243名患者中有200名现已参加该公司正在进行的潜在关键性研究，该研究评估了Berubicin治疗复发性GBM（一种侵袭性和不可治愈的脑癌）。。

This potentially pivotal, global study of Berubicin is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line therapy and compared to Lomustine as the standard of care (SOC). The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint that the FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

这项潜在关键的全球性Berubicin研究是一项适应性，多中心，开放标签，随机对照研究，针对标准一线治疗失败后复发性GBM（WHO IV级）的成年患者，并与洛莫司汀作为护理标准进行比较（SOC）。该研究的主要终点是总生存期（OS），这是一个严格的终点，当相对于随机对照组显示统计学显着改善时，FDA已将其视为批准肿瘤药物的基础。

The Company has opened 46 clinical trial sites of the approximately 60 sites selected across the U.S., Italy, France, Spain, and Switzerland..

该公司在美国，意大利，法国，西班牙和瑞士选择的大约60个地点中开设了46个临床试验场所。。

'As we have noted previously, patient volunteers and their treating clinicians are the backbone of our Berubicin development program. We are deeply sensitive to the fact that these brave patients are facing the battle of their lives and we are forever in their debt for the trust and confidence they and their treating clinicians have in Berubicin and the Company.

“正如我们之前所指出的，患者志愿者和他们的治疗临床医生是我们的柔红霉素开发计划的支柱。我们对这样一个事实非常敏感，即这些勇敢的病人正面临着他们生活的战斗，我们永远为他们及其治疗临床医生对柔比星和公司的信任和信心承担责任。

That 200 such individuals have joined our trial helps to create the robust sample set we have desired from the beginning as we seek to conclusively demonstrate Berubicin's potential. All of us at the Company acknowledge that we simply cannot bring this exciting drug candidate forward without these remarkable patients.

200个这样的人加入了我们的试验，有助于创建我们从一开始就希望的强大样本集，因为我们试图最终证明Berubicin的潜力。我们公司的所有人都承认，如果没有这些杰出的病人，我们根本无法带来这个令人兴奋的候选药物。

Furthermore, we believe the rapid and consistent pace of enrollment is not just remarkable in itself but continues to represent the extraordinarily high level of interest and enthusiasm among our investigators and patients. Addressing this devastating disease continues to be the driving force for our team and we are pleased to achieve this landmark milestone.

此外，我们相信，快速一致的入学速度本身不仅显着，而且继续代表我们调查人员和患者非常高的兴趣和热情。解决这种破坏性疾病仍然是我们团队的推动力，我们很高兴实现这一具有里程碑意义的里程碑。

Importantly, this takes us one step closer to bringing the study across the finish line and potentially offering an effective treatment in GBM that is safe and well tolerated,' commented John Climaco, CEO of CNS Pharmaceuticals..

重要的是，这使我们更接近将研究带入终点，并有可能在GBM中提供安全且耐受性良好的有效治疗，“CNS Pharmaceuticals首席执行官John Climaco评论道。。

As previously announced, CNS Pharmaceuticals has reached the criteria required by the study protocol to conduct a pre-planned, non-binding futility analysis, which an independent Data Safety Monitoring Board (DSMB) will review to determine whether to recommend continuing the study as planned or modifying the study based on Berubicin showing potential value as a second-line treatment for patients with glioblastoma.

如前所述，CNS Pharmaceuticals已达到研究方案要求的标准，以进行预先计划的，无约束力的无效分析，独立的数据安全监测委员会（DSMB）将对其进行审查，以确定是否建议按计划继续研究或根据显示作为胶质母细胞瘤患者二线治疗潜在价值的Berubicin修改研究。

CNS Pharmaceuticals previously reported that the Company would conduct this analysis after at least 50% of the patients in the population to be analyzed for the interim analysis (30-50% of the total number of patients for this trial) had reached the primary efficacy endpoint, as provided for in the study protocol.

CNS Pharmaceuticals先前报道，该公司将在待分析人群中至少50%的患者进行中期分析（该试验患者总数的30-50%）达到主要疗效后进行此分析终点，如研究方案中所述。

The DSMB will review the number of deaths in each arm to ensure that the overall survival of patients receiving Berubicin shows at least a statistically significant comparability to those receiving Lomustine. Additional analyses will include comparisons of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments.

DSMB将审查每组的死亡人数，以确保接受柔红霉素治疗的患者的总生存率与接受洛莫司汀治疗的患者的总生存率至少具有统计学显着的可比性。其他分析将包括次要终点的比较，包括无进展生存期（PFS），有效率和安全性评估。

The Company is confident it will announce the results from the interim analysis publicly before the year end. Enrollment will continue during the interim analysis..

公司有信心在年底之前公开公布中期分析的结果。中期分析将继续报名。。

For more information about this trial, visit clinicaltrials.gov and reference identifier NCT04762069.

有关此试验的更多信息，请访问clinicaltrials.gov和参考标识符NCT04762069。

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the agency for guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA, which may provide seven years of marketing exclusivity upon approval of an NDA..

FDA已授予CNS Pharmaceuticals Fast Track指定用于柔红霉素，从而能够与该机构进行更频繁的互动，以加快开发和审查过程。此外，该公司已获得FDA的孤儿药指定，经NDA批准，可提供七年的营销专有权。。

About Berubicin

关于Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation.

Berubicin是一种蒽环类药物，是一类抗癌药物，是最强大的化疗药物之一，对任何其他类型的化疗药物都能有效对抗更多类型的癌症。蒽环类药物旨在利用自然过程通过干扰拓扑异构酶II（一种使细胞增殖的关键酶）的作用来诱导靶向癌细胞中的脱氧核糖核酸（DNA）损伤。

Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center..

Berubicin治疗脑癌患者似乎表现出积极的反应，包括Reata Pharmaceuticals，Inc。进行的1期人体临床试验中的一项持久完全反应。Berubicin由大学药物化学教授Waldemar Priebe博士开发。德克萨斯州MD安德森癌症中心。。

About CNS Pharmaceuticals, Inc.

关于CNS制药公司。

CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier.

CNS Pharmaceuticals是一家临床阶段制药公司，开发一系列抗癌候选药物，用于治疗脑和中枢神经系统的原发性和转移性癌症。该公司的主要候选药物Berubicin是一种新型蒽环类药物，也是第一种似乎穿过血脑屏障的蒽环类药物。

Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer..

Berubicin目前正在开发中，用于治疗许多严重的脑部和中枢神经系统肿瘤学适应症，包括多形性胶质母细胞瘤（GBM），一种侵袭性且无法治愈的脑癌。。

For more information, please visit www.CNSPharma.com, and connect with the Company on Twitter, Facebook, and LinkedIn.

有关更多信息，请访问www.CNSPharma.com，并与Twitter，Facebook和LinkedIn上的公司联系。

Forward Looking Statements

前瞻性声明

Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company's completion of enrollment of the study and the timing of the interim analysis each to occur before year end, the ability to continue to open additional clinical trial sites on a timely basis, and whether the FDA will recognize the Company's primary endpoint as a basis for approval.

本新闻稿中的一些陈述是1933年“证券法”第27A条，1934年“证券交易所法”第21E条和1995年“私人证券诉讼改革法”含义范围内的前瞻性陈述，涉及风险和不确定性。本新闻稿中的前瞻性声明包括但不限于公司完成研究报名以及每年在年底之前进行中期分析的时间安排，以及能够及时继续开放额外的临床试验场所，以及FDA是否会将公司的主要终点视为批准的基础。

These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements.

这些陈述涉及未来事件，未来期望，计划和前景。尽管CNS认为此类前瞻性陈述中反映的预期截至日期是合理的，但预期可能证明与此类前瞻性陈述所表达或暗示的结果存在实质性差异。

CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.

CNS试图通过包括“相信”，“估计”，“预期”，“期望”，“计划”，“项目”，“意图”，“潜在”，“可能”，“可能”，“可能”，“可能”，“将会”，“应该”，“大约”或其他表达未来事件或结果不确定性的词语来识别这些前瞻性陈述。

These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. 'Risk Factors' in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ('SEC') and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC.

这些陈述只是预测，涉及已知和未知的风险，不确定性和其他因素，包括第1A项讨论的因素风险因素”在中枢神经系统最近提交的向美国证券交易委员会（SEC）提交的表格10-K中，并以其10-Q文件形式不时更新，并在其与SEC的其他公开文件中更新。

Any forward-looking statements contained in this press releas.

本新闻稿中包含的任何前瞻性声明。

CONTACTS:

联络：

Investor Relations Contact

投资者关系联系

JTC Team, LLC

JTC团队

Jenene Thomas

珍妮·托马斯

833-475-8247

833-475-8247

CNSP@jtcir.com

CNSP@jtcir.com

SOURCE: CNS Pharmaceuticals, Inc.

来源：CNS制药公司。

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