Edmonton, Alberta, Canada January. 16, 2023. 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. 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.
The Phase 1 dose escalation safety and tolerability study was conducted in 29 heavily pre-treated solid tumor and lymphoma patients who averaged 4 prior lines of therapy on which they relapsed or were refractory (R/R). Eight colorectal, two pancreatic, and one appendiceal cancer patients were among those included in the study. The most common treatment related adverse events identified in the trial were mild to moderate gastrointestinal side effects which were self-limiting and occurred in a minority of patients. A recommended Phase 2 dose (RP2D) for expansion studies was established. Zelenirstat prolonged progression free and overall survival in Phase 1 solid tumor patients receiving the RP2D. Prolonged Stable Disease was observed in patients with colorectal (320 + days on treatment and continuing with non-RECIST criteria reductions of approximately 50% in CEA (carcinoembryonic antigen) and tumor volumes) and appendiceal (160+ days on treatment and continuing with stable disease) cancer treated with the RP2D. The Company has initiated dosing in a Phase 2a expansion study of patients with B-cell non-Hodgkin lymphoma.
A poster describing the Company’s Phase 1 study safety results and efficacy signals, particularly in gastrointestinal cancer patients, will be presented at the ASCO Gastrointestinal Cancers Symposium on January 18-20, 2024, in San Francisco, CA. The Company’s CEO, Dr. Michael Weickert, will be available during the poster session and for one-on-one meetings. The details of the poster are below:
“The extended benefits observed in patients with heavily pre-treated GI cancers has been an exciting clinical study finding,” said Dr. John Mackey, Chief Medical Officer for Pacylex and a practicing oncologist. “Those patients have received the Phase 2 dose of zelenirstat for longer than anyone and the reductions in disease burden in the colorectal patient is very encouraging.”
For additional information, please visit www.pacylex.com
For more information contact: Michael J. Weickert CEO, Pacylex Pharmaceuticals, Inc. E: michael.weickert@pacylex.com P: 650-218-1840
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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.
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