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Moleculin Announces Interim Data in Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases
- Preliminary data from two cohorts evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases currently demonstrate 80% clinical activity,
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"- Preliminary data from two cohorts evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases currently demonstrate 80% clinical activity, defined as stable disease and/or better\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\n HOUSTON, Oct. 18, 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 interim results from its U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases, which documented preliminary clinical activity for Annamycin. \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, who have failed prior chemotherapy, and for whom new chemotherapy is considered appropriate. A minimum of 3 subjects will be enrolled in each of up to 6 cohorts of the Phase 1b portion of the study, or until an MTD is identified, whichever comes first. A maximum of 25 subjects will be enrolled at the RP2D to further evaluate efficacy.\n\"To witness the activity of Annamycin in the treatment of STS lung metastases, even this early in a Phase 1 trial, we believe is encouraging. Four of the five patients that have completed scans to date demonstrated a response to treatment, including three with extended and, in one case, continuing stable disease and one patient with a substantial (>30%) reduction in tumor size. These interim data bolster our optimism about the potential for Annamycin to address the limitations with the current standard-of-care treatment options for STS lung metastases. Ultimately, we believe Annamycin has the potential to bring a new and effective treatment option to patients with a significant unmet need. With these data now in hand, we are cautiously optimistic a...