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Pacylex Pharmaceuticals Reports Safety and Efficacy Results from Its Phase 1 First-In-Human Study of Zelenirstat (PCLX-001)


Edmonton, Alberta–(Newsfile Corp. – December 1, 2023) – Pacylex Pharmaceuticals Inc. (Pacylex), a clinical-stage pharmaceutical company focused on the development of a new class of targeted therapies for the treatment of hematologic and solid tumor cancers, today 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, will be included in investor updates presented at upcoming conferences in December and January.

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

Key Takeaways:

  • Phase 1 safety and tolerability of zelenirstat was acceptable and a recommended Phase 2 dose was established.
  • Zelenirstat unexpectedly prolonged progression free survival in solid tumor patients in Phase 1 at the recommended Phase 2 dose.
  • Pacylex will report Phase 1 safety results and potential efficacy signals at upcoming life science investment conferences in December 2023 and January 2024.

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About 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 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. 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. 

Forward-Looking Statements
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. 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. 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. Forward-looking statements and forward-looking information are based on the beliefs of management as well as assumptions made by and information currently available to management as of the date hereof, and none of the Company or its affiliates undertakes any obligation to update or issue revisions to any forward-looking statements or forward-looking information contained herein to reflect any future events or circumstances, except as required by law. The foregoing does not constitute an offer or solicitation to acquire any securities in the Company or any related or associated entity or affiliate. The information contained herein is not intended as legal, tax, financial or investment advice. Furthermore, the information contained herein may not be applicable to or suitable for an individual’s specific circumstances or needs.

Contacts:

Michael Weickert Ph.D
650-218-1840
michael.weickert@pacylex.com

Source: Pacylex

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/189481

 

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