Moleculin Biotech Inc. (NASDAQ: MBRX) has announced interim findings from the company’s US phase 1/2 study following the completion of a safety review of a third cohort and has opened the fourth cohort in the dose-escalation study assessing Annamycin for soft tissue sarcoma lung metastases treatment.
Study to determine Annamycin’s maximum tolerated dose
The Phase 1b/2 study is a multi-site, single-arm, open-label trial in the United States that will establish Annamycin’s maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and safety in Phase 1b. Phase 2 part of the study will look into Annamycin’s efficacy as a single drug for treating STS patients with lung metastases who have failed previous chemotherapy and who need new treatment. In the Phase 1b section of the trial, a minimum of three subjects will be enrolled in each cohort until an MTD is determined, after which a recommendation for the RP2D will be made based on an assessment of both efficacy and safety. Around 25 participants will be recruited at the RP2D in the second phase to assess efficacy further.
Moleculin CEO and President Walter Kemp commented, “Even though this is still early in the Phase 1b portion of the trial, the data continue to be encouraging. Three of the six patients in the first two cohorts reached four or more months with stable disease or better. In a patient population where the median progression-free survival is approximately 1.61 months, we believe Annamycin has the potential to bring a new and effective treatment option to patients with this significant unmet need.”
No cardiotoxicity observed in the STS trial
Kemp added, “Consistent with our earlier and ongoing acute myeloid leukemia trials to date, we continue to see a complete absence of cardiotoxicity in this STS trial. We continue to emphasize this point because, even though anthracyclines are considered a cornerstone chemotherapy for many types of cancer including STS lung metastases, all currently approved anthracyclines are significantly cardiotoxic. Annamycin was designed to overcome this problem and we believe it has the potential to become the first non-cardiotoxic anthracycline approved for use.”
