Edmonton, Alberta, Canada/May 18, 2023– Pacylex Pharmaceuticals, a clinical-stage company developing PCLX-001, a first-in-class oral investigational small molecule for leukemia, lymphoma, and solid tumor cancers, today announced the first patient has been dosed in a Phase 2a expansion study in patients with relapsed/refractory B-cell Non-Hodgkin Lymphoma (R/R NHL).
The Company’s Phase 1 multiple ascending dose (MAD) clinical trial evaluating PCLX-001 monotherapy in patients with R/R NHL or advanced solid tumors successfully completed six dose escalations without any dose-limiting toxicities (DLTs) and reached a drug exposure level expected to show clinical activity. Three patients with advanced solid tumors in the highest dose level are continuing to receive PCLX-001.
The Company received a No Objection Letter from Health Canada earlier this year to initiate the expansion cohort, designed to evaluate a potential Phase 2 dose in patients with R/R NHL. Four Canadian clinical sites have been activated and the first patient has been dosed. The expansion study will enroll up to 20 patients to assess the preliminary clinical activity of PCLX-001.
“The first stage of this first-in-human study assessed the safety of PCLX-001 with repeated dosing. We now transition our clinical investigations from primarily establishing safety to both safety and efficacy at a potential Phase 2 dose,” said Dr. John Mackey, CMO of Pacylex.
“This milestone represents a major step in the development of PCLX-001 as a first-in-class oral cancer therapy” said Pacylex CEO Dr. Michael Weickert. “Our pre-clinical work showed that PCLX-001 at an equivalent dose in animals regressed R/R NHL tumors so it is exciting to see these patients finally receiving this as an investigational therapy” added Dr. Luc Berthiaume, Pacylex CSO and Professor at the University of Alberta.
Twenty-one patients have received PCLX-001 through 6 dose level escalations with no dose limiting toxicities, therefore dose escalation will continue in patients with advanced solid tumors in parallel with the Phase 2a study in patients with R/R NHL. Pacylex anticipates that it will present an update from the Phase 1 dose escalation portion of the study at a scientific conference this year.
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