Edmonton, Alberta--(Newsfile Corp. - January 17, 2024) - Pacylex Pharmaceuticals Inc. (Pacylex) is a clinical-stage pharmaceutical company focused on the development of a new class of targeted therapies, N-myristoyltransferase inhibitors (NMTi) for the treatment of hematologic and solid tumor cancers.

艾伯塔省埃德蒙顿市--（新闻文件公司-2024年1月17日）-Pacylex Pharmaceuticals Inc.（Pacylex）是一家临床阶段制药公司，专注于开发一类新的靶向疗法，N-肉豆蔻酰转移酶抑制剂（NMTi），用于治疗血液学和实体瘤癌症。

Today Pacylex announced that the results of its Phase 1 dose escalation safety and tolerability study for zelenirstat, an investigational NMT inhibitor and Pacylex's lead product candidate, in refractory/ relapsed colorectal and other cancers, will be presented January 20, 2024, at the upcoming ASCO Gastrointestinal Cancers Symposium..

今天，Pacylex宣布，其针对难治性/复发性结直肠癌和其他癌症的研究性NMT抑制剂和Pacylex的主要候选产品zelenirstat的第一阶段剂量递增安全性和耐受性研究结果将于2024年1月20日在即将举行的ASCO胃肠道癌症研讨会上发表。。

To view the full announcement, including downloadable images, bios, and more, click here.

要查看完整的公告，包括可下载的图像、bios等，请单击此处。

Key Takeaways:

关键要点：

Pacylex presents zelenirstat results in gastrointestinal and other cancer patients at the ASCO Gastrointestinal Cancers Symposium on January 18-20, 2024, in San Francisco, CA.

Pacylex于2024年1月18日至20日在加利福尼亚州旧金山举行的ASCO胃肠道癌症研讨会上介绍了zelenirstat在胃肠道和其他癌症患者中的结果。

Zelenirstat prolonged progression free survival in gastrointestinal and other cancer patients in Phase 1 at the recommended Phase 2 dose.

Zelenirstat在推荐的2期剂量下延长了1期胃肠道和其他癌症患者的无进展生存期。

An advanced colorectal cancer patient relapsed from 7 prior lines of therapy, has seen reductions of approximately 50% in CEA and tumor volumes so far with zelenirstat.

一名晚期结直肠癌患者从之前的7种治疗方案中复发，到目前为止，zelenirstat的CEA和肿瘤体积减少了约50%。

Click image above to view full announcement.

单击上面的图片查看完整公告。

About zelenirstat (PCLX-001)

关于zelenirstat（PCLX-001）

Zelenirstat (formerly identified as PCLX-001) is a first-in-class, oral, small molecule N-myristoyltransferase (NMT) inhibitor being developed to treat patients with leukemia, lymphoma, and solid tumors. In animal models, zelenirstat selectively killed cancer cells in vitro and has been shown to regress hematologic malignancies and inhibit the growth of lung and breast cancer tumors.

Zelenirstat（以前被鉴定为PCLX-001）是一种一流的口服小分子N-肉豆蔻酰转移酶（NMT）抑制剂，正在开发用于治疗白血病，淋巴瘤和实体瘤患者。在动物模型中，zelenirstat在体外选择性杀死癌细胞，并已被证明可以消退血液系统恶性肿瘤并抑制肺癌和乳腺癌肿瘤的生长。

In AML models, zelenirstat killed leukemic stem enriched cell populations and allowed the regeneration and growth of normal bone marrow cells..

在AML模型中，zelenirstat杀死了白血病干细胞富集的细胞群，并允许正常骨髓细胞的再生和生长。。

About zelenirstat Phase 1 and 2 studies

关于zelenirstat 1期和2期研究

Pacylex completed the dose escalation phase of a Phase 1 multiple ascending dose safety, tolerability, and pharmacokinetics study on zelenirstat in R/R lymphoma and solid tumor patients (NCT04836195). A recommended Phase 2 dose was determined. Zelenirstat demonstrated an acceptable safety and tolerability profile, pharmacokinetics consistent with once daily oral dosing, and early signs of potential efficacy..

Pacylex完成了R/R淋巴瘤和实体瘤患者中zelenirstat的1期多重递增剂量安全性，耐受性和药代动力学研究的剂量递增阶段（NCT04836195）。确定了推荐的2期剂量。Zelenirstat表现出可接受的安全性和耐受性，药代动力学与每日一次口服给药一致，以及潜在疗效的早期迹象。。

Zelenirstat is currently being studied in a Phase 2a open-label study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of zelenirstat in patients with R/R B-cell non-Hodgkin Lymphoma (NHL). A separate Phase 2a cohort is planned in advanced solid malignancies who have progressed on all available standard therapies..

Zelenirstat目前正在进行2a期开放标签研究，旨在评估Zelenirstat在R/R B细胞非霍奇金淋巴瘤（NHL）患者中的安全性，耐受性，药代动力学，药效学和临床活性。计划在所有可用的标准疗法上取得进展的晚期实体恶性肿瘤中进行单独的2a期队列研究。。

About Pacylex Pharmaceuticals

关于Pacylex Pharmaceuticals

Pacylex is a clinical-stage pharmaceutical company headquartered in Edmonton, Alberta, Canada, targeting hematologic and solid cancers with orally bioavailable NMT inhibitors. Zelenirstat is the lead drug in a new class of NMT inhibitors, enabling Pacylex to exploit NMTs as new clinical targets for cancer treatment.

Pacylex是一家临床阶段制药公司，总部位于加拿大阿尔伯塔省埃德蒙顿，以口服生物可利用的NMT抑制剂治疗血液和实体癌。Zelenirstat是一类新型NMT抑制剂的先导药物，使Pacylex能够利用NMT作为癌症治疗的新临床靶点。

Pacylex is conducting a multi-center Phase 1/2a study in Canada in patients with R/R NHL and advanced solid tumors. The IND for a Phase 1 multiple ascending dose study in acute myeloid leukemia (AML) has been cleared and the FDA has granted zelenirstat both Orphan Drug Designation and Fast Track Designation for AML.

Pacylex正在加拿大对R/R NHL和晚期实体瘤患者进行多中心1/2a期研究。急性髓细胞白血病（AML）第一阶段多剂量递增研究的IND已被清除，FDA已授予zelenirstat AML孤儿药指定和快速通道指定。

The US Department of Defense is supporting the initial clinical investigation of zelenirstat in patients with AML. The Cure Cancer Foundation supported initial clinical studies through its World's Longest Games..

美国国防部正在支持zelenirstat对AML患者的初步临床研究。治愈癌症基金会通过其世界上最长的运动会支持了初步的临床研究。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws, such as statements relating to future events or the Company's future financial and operating performance, as well as the Company's business plans, growth initiatives, and objectives and prospects.

本新闻稿包含适用证券法意义下的前瞻性声明和前瞻性信息，例如与未来事件或公司未来财务和经营业绩以及公司业务计划、增长计划、目标和前景有关的声明。

Generally, forward-looking statements and forward-looking information may be identified by the use of forward-looking terminology, including the words 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'should,' 'plan,' 'goal,' 'expect,' 'strategy,' 'future,' 'likely,' 'proposed,' 'scheduled,' 'forecast,' 'budget,' 'could,' 'would,' variations of such words of phrases and other similar expressions, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved.

一般来说，前瞻性陈述和前瞻性信息可以通过使用前瞻性术语来识别，包括“相信”、“可能”、“将会”、“估计”、“继续”、“预期”、“打算”、“应该”、“计划”、“目标”、“预期”、“战略”、“未来”、“可能”、“提议”、“预定”、“预测”、“预算”、“可能”、“会”、“会”，“这些短语和其他类似短语的变体，或者通过使用声明某些行动、事件或结果可能、可能、将会或可能发生或实现的单词或短语。

However, the absence of these words does not mean that a statement is not forward looking. Forward-looking statements and forward-looking information are subject to numerous factors, risks and uncertainties that could cause actual results to differ materially, including, but not limited to, the Company's ability to successfully execute on its business plans and strategies, avoid delays in planned clinical trials, hire and retain key personnel, obtain appropriate or necessary governmental approvals to market potential products and obtain future funding for product development and working capital on commercially reasonable terms, changes in laws, and  general macroeconomic conditions, including economic slowdowns, recessionary risks, rising inflation and interest rates, and supply chain disruptions.

然而，不使用这些词语并不意味着声明不具有前瞻性。前瞻性陈述和前瞻性信息受到许多因素、风险和不确定性的影响，这些因素、风险和不确定性可能导致实际结果产生重大差异，包括但不限于公司成功执行其业务计划和战略、避免计划临床试验延误、雇佣和留住关键人员的能力，获得适当或必要的政府批准，以营销潜在产品，并以合理的商业条款、法律变化和一般宏观经济状况（包括经济放缓、衰退风险、通货膨胀和利率上升以及供应链中断）为产品开发和营运资金获取未来资金。

Forward-looking statements and forward-looking information are based on the beliefs of managemen.

前瞻性陈述和前瞻性信息基于管理层的信念。

Contacts:

联系人：

Michael Weickert Ph.D

Michael Weickert博士。

650-218-1840

650-218-1840

michael.weickert@pacylex.com

michael.weickert@pacylex.com

Source: Pacylex

资料来源：Pacylex

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/194619

要查看此新闻稿的源版本，请访问https://www.newsfilecorp.com/release/194619