On July 2, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported an update on its clinical development plan for Annamycin (Press release, Moleculin, JUL 2, 2020, View Source [SID1234561656]).
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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)
After consultation with both US and European regulatory agencies, Moleculin has mapped out a course for development of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML"). In its End of Phase 1 meeting with the US Food and Drug Administration ("FDA") the Company agreed to expand its protocol-mandated testing for cardiotoxicity throughout the remainder of its European Phase 1 trial. The expansion of testing will provide additional safety data, investigating the continued evidence of little to no cardiotoxicity, and efficacy data that both US and European regulators may consider as the Company prepares to transition to a Phase 2 clinical trial, which management believes will focus on Europe.
Moleculin has now received approval from European authorities to increase the increment for dose-escalation from 30 mg/m2 per cohort to 60 mg/m2 per cohort, as treatment to date in its clinical trials has been at what the Company considers to be subtherapeutic levels. The first patient in the European trial has now been treated at 240 mg/m2 with no evidence of cardiotoxicity or other dose limiting toxicities. Once 2 more patients are successfully treated at this level, the next cohort will be treated with 300 mg/m2. With these timing and dosing expectations, the Company believes that European dosing will increase in 2020, allowing a recommended Phase 2 Dose to be established in 2021.
"Based on what we know from prior clinical trials, we think it may require a dose level of 300 to 360 mg/m2, or possibly higher, before we begin to see a solid therapeutic window for Annamycin in AML," commented Walter Klemp, Chairman and CEO of Moleculin. "Now, with 5 clinical sites open in Poland, the European trial is in the best position to complete the safety portion of our development. That also allows us to close out the US trial, which has already reached its primary safety endpoint."
The Company intends to use what it learns from the Phase 1 clinical trials in AML to inform the starting dosage in clinical testing of Annamycin for the treatment of lung metastases, for which it hopes to file an Investigational New Drug application or its European equivalent by the end of this year.
Mr. Klemp concluded: "With the confirmation of animal model activity in lung metastases we just announced last week, we are pushing hard to prepare to seek regulatory approval to begin a Phase 1 clinical trial in sarcomas that have metastasized to the lungs, a condition for which there is a significant unmet need."