Despite disruptions from the COVID-19 pandemic, Moleculin Biotech is aiming to expand the number of sites for clinical trials of its annamycin chemotherapy for the treatment of acute myeloid leukemia (AML).
The Phase 1/2 clinical study (NCT03388749) currently takes place at five European sites. Moleculin has submitted requests to the Polish Department of Registration of Medicinal Products (URPL) to include hospitals in the cities of Szczecin and Kielce.
“Assuming these requests are granted in a timely manner, we expect both sites to begin recruiting in the third quarter,” Walter Klemp, chairman and cEO of Moleculin, said in a press release.
Annamycin is a next-generation anthracycline, which is a type of chemotherapy. These new therapies are designed to overcome limitations associated with other anthracyclines, particularly heart damage (cardiotoxicity) and resistance on the part of cancer cells.
Similar to other cancer chemotherapies, annamycin stops DNA replication by inserting itself into the DNA in a body’s cells — a process called intercalation. That blocks the proteins that copy DNA during cell division. This strategy has proven effective in treating cancer because cancer cells divide much more frequently than non-cancerous cells.
The URPL had previously granted Moleculin permission to accelerate the dose-escalation portion of its trial, in which successive groups of patients receive increasing doses of the medicine. The treatment is delivered intravenously (directly into the vein) for three consecutive days within a three-week treatment cycle.
The study’s goal is to determine the maximum tolerated dose: the highest dose that can be given without causing unacceptable side effects. The trial also is expected to determine the optimum therapeutic dose for further clinical testing.
Moleculin has conducted a similar trial of annamycin in the United States (NCT03315039). The results showed no unexpected serious adverse events or dose-limiting toxicities at any tested dose. Additionally, as of February 2020, there were no signs of heart damage in all patients given Annamycin in the U.S. and European trials.
Annamycin has already received fast track and orphan drug designation from the U.S. Food and Drug Administration as a potential AML treatment. Those designations help to speed the potential approval of new medications for rare diseases.
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