Moleculin is a clinical stage pharmaceutical company with six anti-cancer drugs in the pipeline, and to augment its US clinical trials, has turned to Poland, where it has been able to more quickly recruit patients.
According to the Houston, TX-based company, it recently recruited three patients in six weeks in Poland, compared to nearly a full year to build a similar cohort in the US.
Working with the medical community in Poland – where Moleculin’s founding scientist Dr. Waldemar Priebe was born – a Phase I/II clinical trial is currently underway for the company’s Annamycin compound for the treatment of acute myeloid leukemia (AML).
Why Poland?
Walter Klemp, CEO of Moleculin, cited the significant competition for patients in the US: “And with no centralized database for clinical trials, and with other databases that are not always inclusive, patients and doctors frequently are not even aware of what trials are available,” he added.
Additionally, patients in Poland have fewer opportunities to be treated, Klemp said, “and they may have to wait a long time for access to a specialist, making them much more interested in participating in trials.” As part of this, the country also has a greater number of patients who are treatment-naïve.
Poland also has a medical infrastructure acceptable to the US Food and Drug Administration (FDA) and offers many benefits to the small biopharma, and, according to Moleculin, is ranked seventh in Europe for clinical trial participation, with an annual average of about 40,000 patients in clinical trials.
Per a report published by the contract research organization (CRO) Cromsource, the clinical trial market in Poland was estimated to be about €200m as of 2014.
The European Medicines Agency (EMA) also allows drug doses in clinical trials to start at higher, more therapeutic levels, explained Klemp. “The fact that the trials often start with sub-therapeutic doses can actually prolong trial duration, making patients wait even longer to see any possible positive results,” he said.
Klemp explained that for the current Moleculin trial being conducted in Poland the allowable starting dose was 120 mg/m2, compared to the 100 mg/m2 required in the US. After three patients have completed the safety evaluation period of the first cohort in Poland, the second cohort will begin a dose level of 150 mg/m2.
“Health officials in Poland have been fairly proactive in asking for input from drug developers regarding how they can improve their process,” Klemp added. “As one would expect, changes are gradual, but our expectation is that clinical development will continue to get more efficient there over the next five years.”
