Pacylex Announces FDA Clearance of IND Application for PCLX-001 to Treat Acute Myeloid Leukemia

2022-11-03

孤儿药First in Class小分子药物

Edmonton, Alberta--(News - November 2, 2022) - Pacylex, a clinical-stage NMT inhibitor company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PCLX-001 for the treatment of acute myeloid leukemia (AML). The open IND enables a Phase 1/2 clinical study to start in the coming months at The University of Texas MD Anderson Cancer Center, which was recently awarded a US Department of Defense (DOD) grant for this purpose. To view the full announcement, including downloadable images, bios, and more, click here. Key Takeaways: Pacylex seeks to improve treatment outcomes in leukemia and lymphoma patients with PCLX-001, a first-in-class N-myristoyltransferase (NMT) inhibitor which inhibits myristoylation in cancer cells where this process is fundamental for cancer cell proliferation and survival. Pacylex plans to start its second clinical program in AML; PCLX-001 is currently in clinical studies at 4 hospitals in Canada in Non-Hodgkin Lymphoma and solid tumor patients. The company received FDA Orphan Drug Designation for PCLX-001 in AML and will launch its Phase 1 study in the next quarter. Click image above to view full announcement. PCLX-001 PCLX-001 (aka DDD86481) is a first-in-class, small molecule NMT inhibitor originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness, funded by Welcome Trust. Pacylex is developing PCLX-001 in the form of a once-a-day pill initially to treat leukemia and lymphoma. PCLX-001 has also been shown to inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the levels of NMT2 are correlated with survival, suggesting an important biological role in these cancers. About Pacylex Pacylex is a pharmaceutical company headquartered in Edmonton, Alberta, Canada, targeting hematologic and solid cancers with a new first-in-class therapeutic, PCLX-001. Pacylex's technology combines new insights from Dr. Luc Berthiaume of the University of Alberta connecting myristoylation to cancer with a family of high quality myristoylation inhibitors Pacylex licensed from the University of Dundee. PCLX-001 is the lead drug in a new class of NMT inhibitors, enabling Pacylex to exploit NMTs as new clinical targets for cancer treatment. Pacylex initiated clinical studies in Canada in the fall of 2021 in non-Hodgkin lymphoma and solid tumors. Pacylex is also receiving support from an Alberta Innovates AICE grant in 2020, and the research leading to this breakthrough was supported in part by the Alberta Cancer Foundation and the Cure Cancer Foundation. The US Department of Defense is supporting the initial clinical investigation of PCLX-001 in AML patients. For more information: Pacylex Pharmaceuticals Contact: Michael J. Weickert CEO, Pacylex Pharmaceuticals, Inc. E: michael.weickert@pacylex.com P: 650-218-1840 Twitter @Pacylex ( ) LinkedIn ( ) Facebook ( ) Reportable page: ( ) #cancer, #lymphoma, #leukemia, #albertacancer, #Pacylex, #PCLX001, #UAlberta; #UAlberta_FoMD; #Worldslongestgame, #ASH22, #MDACC, #AML 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

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构