Moleculin Biotech Inc (NASDAQ:MBRX), the US biopharmaceutical group, is bolstering US trials for its anti-cancer drugs by hosting trials in Poland to quicken the pace of patient recruitment and data collection.
A Phase 1/2 clinical trial is now underway in Poland for the Houston company’s Annamycin compound, which is showing considerable promise as one participating patient’s acute myeloid leukemia is now in remission. This makes the patient eligible for a bone marrow transplant.
Moleculin has already identified more patients in Poland for the next cohort of the same trial, as well as two more patients for its WP1220 topical treatment of cutaneous T-cell lymphoma.
READ: Moleculin Biotech gets nod from Polish regulator to begin clinical trials of its leukemia drug
The Texas company recently recruited three patients in six weeks in Poland, whereas in the US, it took a year to find a similar group of patients. Moleculin now has two clinical trials with patients enrolled in Poland.
“The clock is ticking for many patients suffering from hard-to-combat cancers,” said Walter Klemp, CEO of Moleculin in a statement. “For a smaller pharmaceutical company with a promising roster of drug candidates for targeting these highly resistant tumors, speed in launching trials is critical.”
Looking ahead, the company is hoping to advance the clinical study of Annamycin with the goal of demonstrating the drug’s safety and effectiveness to support regulatory approval in the US and the European Union.
The additional data on patient safety gleaned from the Polish trials may also assist in the FDA’s review of cardiac safety, which can be a key factor in winning regulatory approval for a drug.
Moleculin Biotech is a clinical-stage pharmaceutical company focused on the development of oncology drugs, which are based on discoveries made at MD Anderson Cancer Center. The company’s clinical-stage drugs are Annamycin, an anthracycline with little to no cardiotoxicity is being studied for the treatment of relapsed or refractory acute myeloid leukemia, as well as WP1066, an immuno-stimulating STAT3 inhibitor targeting brain tumors and pancreatic cancer as well as acute myeloid leukemia.