Moleculin Biotech Seeks Study Approval in Poland

Moleculin Biotech (NASDAQ:MBRX) announced it submitted a request for Clinical Trial Authorization (CTA) in Poland to study Annamycin for the treatment of relapsed or refractory acute myeloid leukemia.
As quoted in the press release:

This will be in addition to the previously announced allowance of its Investigative New Drug filing with the Food & Drug Administration in the US.
“Consistent with our prior guidance, we have now taken the final step required to expand our Annamycin clinical trial to Poland,” commented Walter Klemp, Chairman and CEO of Moleculin. “Unlike the US, the process for beginning a clinical trial in Poland requires a hospital contract before a request for CTA can be made. We recently announced the required hospital contract and this announcement now marks the formal request for Polish approval.”
Mr. Klemp continued: “The CTA request process in Poland normally takes 60 days, so we hope to be enrolling patients there near year-end. Increasing the breadth of clinical trial sites beyond the US will give Moleculin access to more potential patients, and, hopefully, speed the Phase IIa portion of the trial.”

Click here to read the full press release.

Source: www.marketwired.com