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Why Expensive U.S. Drug Trials are Pushing Pharma Research Overseas - Seite 2

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced additional positive interim safety and efficacy data from its ongoing open label, single arm Phase 1/2 study of Annamycin in Poland. After receiving a single starting dose of 120 mg/m² in the first cohort of the dose escalation phase of the trial, 2 of 3 patients treated responded sufficiently to qualify for a potentially curative bone marrow transplant. The results for all 3 patients were reviewed by the Safety Review Committee, which determined that no drug-related adverse events were observed that would prevent advancing the trial to the next higher dose level of 150 mg/m². To date in the European trial, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other adverse events related to Annamycin have been reported.  No additional patient data have been developed in the Company's parallel US clinical trial, which is currently recruiting its second cohort to be given a dose level of 120 mg/m² (the US trial started at a lower initial dose of 100 mg/m²).

"The progress in Europe, specifically Poland, continues to be encouraging," commented Walter Klemp, Moleculin's Chairman and CEO. "In just a few months, we have completed the first cohort and we've seen a partial response from 2 out of 3 patients sufficient to qualify them for a potentially curative bone marrow transplant. It's important to remember that these are relapsed or refractory patients for whom the standard of care failed. So, to see this kind of response at the starting dose level in the dose-ranging phase, we believe is quite remarkable. And, although this data is still preliminary and may not be indicative of the ultimate outcome of the trial, the improvement in activity at 120 mg/m² in Poland as compared with the 100 mg/m² cohort in the US is consistent with our expectations for Annamycin."

Mr. Klemp continued: "Recognizing that cardiotoxicity is a significant limitation of existing therapies, we are pleased that we continue to see no evidence of cardiotoxicity in any of the patients treated thus far. Specifically, there was no observed reduction in left ventricle ejection fraction, which is the standard metric for acute cardiotoxicity, nor any change in biomarkers that would indicate the potential for long-term cardiovascular impairment.  This is an important step in the ongoing clinical study of Annamycin and toward our goal of ultimately demonstrating the drug's safety and effectiveness to support regulatory approval in both the US and European Union."