Moleculin recently recruited 3 patients in 6 weeks in Poland, whereas in the U.S. it took a full year to build a similar, complete cohort. The company now has 2 clinical trials with patients enrolled in Poland.
The phase 1/2 clinical trial now underway in Poland for the company’s Annamycin compound has already shown promising results with one trial patient’s acute myeloid leukemia (AML) now in remission, making the patient eligible for a bone marrow transplant. While significant additional study is necessary to definitively demonstrate causality, Moleculin has already begun to identify more patients in Poland for the next cohort of the same trial and 2 more patients for its WP1220 topical treatment of cutaneous T-cell lymphoma (CTCL).
“The clock is ticking for many patients suffering from hard-to-combat cancers,” said Walter Klemp, CEO, Moleculin Inc. “For a smaller pharmaceutical company with a promising roster of drug candidates for targeting these highly resistant tumors, speed in launching trials is critical.
We feel lucky to have found a well-established medical community where access to patients is easier and faster. If the promising results continue, we look forward to getting our drugs into the hands of such patients much sooner.”
“While the response of a single patient doesn’t necessarily predict the outcome of the trial, this is a great way to begin and it’s consistent with our expectations for Annamycin,” Klemp said. “We have seen no evidence of cardiotoxicity in any of the patients treated thus far and
intend to advance the clinical study of Annamycin with the goal of ultimately demonstrating the drug’s safety and effectiveness to support regulatory approval in the US and European Union.”
The additional patient safety data gained from the Polish trials may also assist in the FDA’s review of cardiac safety which can be a key factor in regulatory approval.