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WPD Pharmaceuticals Inc. a clinical stage pharmaceutical company is pleased to announce that through its license partner, Moleculin Biotech, Inc. it has been authorized by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, known as URPL, to accelerate the Phase 1 dose escalation portion of its clinical trial of Annamycin for the treatment of acute myeloid leukemia (“AML”).
The URPL has allowed an amendment to the Annamycin clinical trial protocol, which among other things, includes an increase in the dose escalation increment between cohorts from 30 mg/m2 to 60 mg/m2. The clinical trial is currently recruiting suitable patients for the 240 mg/m2 cohort, so this amendment allows the next cohort to increase to 300 mg/m2, assuming all requirements for safety are met with the 240 mg/m2 cohort.
Mariusz Olejniczak, CEO of WPD commented, “As Annamycin continues to advance, and studies so far have demonstrated the absence of any cardiotoxicity, we believe the trial can and should move more aggressively to establish the maximum tolerated dose, or MTD. The URPL authorization 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 300 mg/m2 dosing level will be the first opportunity to test Annamycin at what we expect will be therapeutic levels.”
About WPD Pharmaceuticals
WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions including the Mayo Clinic and Emory University, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.
WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things. The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes 31 countries in Europe and Asia, including Russia.
On Behalf of the Board
CEO, WPD Pharmaceuticals
Email: [email protected]