- WPD Pharmaceuticals (CSE:WBIO) has gained authorisation to accelerate the dose escalation in its 1 clinical trial of the drug, Annamycin
- The company is testing the drug as a potential treatment for acute myeloid leukemia (AML)
- The Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) will allow an increase in dose increments
- The company’s CEO believes that this authorisation will assist in establishing the drug’s maximum tolerated dose
- WPD’s share price remains unchanged, and is currently trading for $0.75 per share
WPD Pharmaceuticals (CSE:WBIO) has gained authorisation to accelerate the dose escalation in its clinical trial of the drug, Annamycin.
The company gained the authorisation through its license partner, Moleculin Biotech Inc. The partners are testing Annamycin as a potential treatment for acute myeloid leukemia (AML) in a Phase 1 clinical trial.
The Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) gave the authorisation. The URPL has allowed an amendment which includes an increase to the trial’s dose escalation increments between cohorts.
The amendment will allow each escalation increment to increase from 30mg/m² to 60mg/m². Subsequently, a cohort of patients taking 240mg/m² of Annamycin will be followed by a cohort of patients taking 300mg/m². This is assuming that the 240mg/m² cohort meets all safety requirements.
WPD is currently recruiting suitable patients for the 240mg/m² dosing portion of its clinical trial. WPD’s CEO, Mariusz Olejniczak, welcomed the acceleration authorisation.
“Studies so far have demonstrated the absence of cardiotoxicity. As Annamycin continues to advance, we believe the trial can and should move more aggressively to establish the maximum tolerated dose (MTD).
“The URPL authorisation now sets the stage to accelerate the dose escalation process. Even though we’ve seen promising activity from Annamycin, the dosing levels may be still sub-therapeutic.
“Based on prior clinical experience with Annamycin, the 300mg/m² dosing level will be the first opportunity to test Annamycin at what we expect will be therapeutic levels,” he said.
WPD’s share price remains unchanged, and is trading for $0.75 per share, as of 10:09am EST.