On march 14, 2022 Pacylex Pharmaceuticals, an oncology company developing a first-in-class, oral drug for a new approach to cancer therapy, reported the publication in the journal Current Oncology of data from the first patient (Press release, Pacylex Pharmaceuticals, MAR 14, 2022, View Source [SID1234645061]). The paper entitled "Novel, First-in-Human, Oral PCLX-001 Treatment in a Patient with Relapsed Diffuse Large B-cell Lymphoma" describes how an eighty-six year old woman with relapsed diffuse large B-cell lymphoma (DLBCL) received oral PCLX-001, a small molecule, N-myristoyltransferase (NMT) inhibitor, as the initial patient in a phase 1 dose escalation clinical trial.
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In this patient, daily oral administration of 20mg PCLX-001 tablets produced a pharmacokinetic profile suitable for single daily dosing: rapid oral absorption followed by an apparent elimination half-life of 16 hours, without systemic accumulation of drug by day 15. This Phase 1 study is primarily intended to determine the safety of PCLX-001 at escalating doses. There were no dose limiting toxicities and the patient completed their 28-day cycle without incident. Subsequently two additional patients successfully completed the 20 mg dose level without dose limiting toxicities and patients are now being dosed at 40 mg daily.
"We are encouraged that the first patient experience with an NMT inhibitor shows the initial dose to be well tolerated and rapidly absorbed, with a PK consistent with a daily oral drug" said John Mackey, CMO of Pacylex.
All three initial patients were enrolled at the Cross Cancer Institute. Dr. Randeep Sangha, the principal investigator for the study of PCLX-001 at the Cross Cancer Institute in Edmonton, said "our first dose level of PCLX-001 in two relapsed diffuse large B-cell lymphoma patients and a metastatic leiomyosarcoma patient went very smoothly and the safety results encouraged us to escalate to the next dose level and continue to explore its potential as a new treatment for patients".
Patient enrollment is continuing, and patients have also been dosed at Princess Margaret Hospital in Toronto and are expected to be dosed at Centre Hospitalier de l’Université de Montréal (CHUM) and the BC Cancer Agency in Vancouver. The study will enroll 20-30 patients in the initial phase. Four principal investigators will oversee the clinical study at the four clinical sites in Canada: Dr. John Kuruvilla at Princess Margaret Cancer Centre in Toronto, Dr. Randeep Sangha at the Cross Cancer Institute in Edmonton, Dr. Laurie Sehn at the British Columbia Cancer Center in Vancouver, and Dr. Rahima Jamal at CHUM in Montreal.
This study is registered at ClinicalTrials.gov Identifier: NCT04836195.