The Polish Department of Registration of Medicinal Products (URPL) has granted Moleculin Biotech permission to accelerate the dose-escalation portion of a Phase 1/2 clinical trial of Annamycin, which is being investigated as a treatment for acute myeloid leukemia (AML).
Annamycin is a next-generation anthracycline (a type of chemotherapy) that was designed to overcome limitations associated with other anthracyclines, particularly heart damage (cardiotoxicity) and resistance on the part of cancer cells.
The therapy is being investigated in a Phase 1/2 trial (NCT03388749), which is currently recruiting participants in Poland. The first part of this trial is a dose-escalation study, meaning that consecutive groups of enrolled participants are given higher and higher doses of Annamycin, which is delivered intravenously (directly into the bloodstream) for three consecutive days within a three-week treatment cycle.
The goal of this study is to determine the medication’s maximum tolerated dose (the highest dose that can be given without causing unacceptable side effects), as well as to figure out the optimum therapeutic dose for further clinical testing.
In the original trial design, each successively enrolled group would be given a dose 30 mg/m2 higher than that of the previous one. The URPL decision increases this to 60 mg/m2. This means that, since the trial is currently recruiting for a group that will be given a dose of 240 mg/m2, the next group that is recruited will be given a dose of 300 mg/m2 (assuming that safety requirements are met for the 240 mg/m2 group).
A similar clinical trial of Annamycin that was conducted in the United States (NCT03315039) recently met its primary safety goal: there were no unexpected serious adverse events or dose-limiting toxicities at any tested dose. Additionally, as of early February 2020, there have been no signs of heart damage in all patients given Annamycin in the U.S. and European trials.
“Now that we have begun to demonstrate the absence of any cardiotoxicity associated with Annamycin, we believe we can and should move more aggressively to establish the maximum tolerated dose, or MTD, for Annamycin. This authorization now sets the stage to accelerate the dose escalation process,” Walter Klemp, chairman and CEO of Moleculin, said in a press release.
“Thus far, even though we’ve seen promising activity from Annamycin, our dosing levels are still sub-therapeutic. Based on prior clinical experience with Annamycin, the 300 mg/m2 dosing level will be our first opportunity to test Annamycin at what we expect will be therapeutic levels.”
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