Moleculin Biotech, Inc., a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported preliminary interim results from its U.S. Phase 1b/2 clinical trial as it concluded the safety review of the third cohort and opens the fourth cohort in a dose escalation trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases, which continues to document preliminary clinical activity for this drug.
The Phase 1b/2 study is a U.S. multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) and safety of Annamycin. The Phase 2 portion of the study will explore the efficacy of Annamycin as a single agent for the treatment of subjects with STS with lung metastases for whom prior chemotherapy has failed, and for whom new chemotherapy is considered appropriate. A minimum of three subjects will be enrolled in each cohort of the Phase 1b portion of the study until an MTD is identified, after which there will be a recommendation for the RP2D based on an assessment of both safety and efficacy. Up to 25 subjects will be enrolled at the RP2D in Phase 2 to further evaluate efficacy.
“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,” commented Walter Klemp, Chairman and CEO of Moleculin.
Mr. Klemp added, “We are also encouraged by the pace of recruitment to date for this trial. To have completed three full cohorts in just the first 6 months of the study is faster than we would have expected, especially for a rare disease like STS lung metastases. Since more sites have now joined the study in this quarter, we believe this should further aid in the pace of recruitment.”
“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,” Mr. Klemp concluded. “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. This could not only reduce the risk of many current anthracycline treatment regimens, but it could also enable longer treatment periods without cardiac risk.”