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Moleculin Announces Preliminary Third Cohort Interim Data in Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases
- Preliminary data currently demonstrate 50% of patients in first two cohorts experienced clinical activity, defined as stable disease and/or better through 4
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"- Preliminary data currently demonstrate 50% of patients in first two cohorts experienced clinical activity, defined as stable disease and/or better through 4 months or more of treatment\n - Patient enrollment and dosing ongoing; no dose-limiting toxicity (DLT) experienced to-date\n - Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma lung metastases\n\n\nHOUSTON, Dec. 27, 2021 /PRNewswire/ -- 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, today 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. \n\n \n \n \n \n \n \n\n \nThe 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.\n\"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.\nMr. Klemp added, \"We are also encouraged by the pace o...