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Moleculin Presents Positive Preliminary Efficacy Findings from Phase 1B/2 Clinical Trial Demonstrating 64% Stable Disease Rate Through Two Cycles of Annamycin for the Treatment of Soft Tissue Sarcomas (STS) Lung Metastases
– Poster Presented at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting – Annamycin continues to be 100% non-cardiotoxic – Annamycin has Fast
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"– Poster Presented at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting\n– Annamycin continues to be 100% non-cardiotoxic\n– Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma\nHOUSTON, Nov. 6, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (\"Moleculin\" or the \"Company\"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced the presentation of preliminary efficacy findings from the Phase 2 portion of the Company's ongoing U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107).\n\n \n \n \n \n \n \n\n \nThe abstract titled, \"A Phase 1b/2 Study of Liposomal Annamycin (ANN) in Subjects with Previously Treated Soft-Tissue Sarcomas (STS) with Pulmonary Metastases,\" was presented by Brian Andrew Van Tine, MD, PhD, Professor of Medicine, Washington University School of Medicine in a poster presentation at the 2023 CTOS Annual Meeting being held November 1-4, 2023 in Dublin, Ireland.\n\"Our growing body of preliminary data demonstrated by Annamycin in the treatment of patients with STS lung mets continues to be encouraging and bolsters our confidence in its potential to be a meaningful option for patients,\" commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. \"While still preliminary, the rates of the median progression free response and the trend being established for overall survival despite the patients in this study having received multiple prior chemotherapy regimens continues to exceed our expectations. We look forward to further data readouts from this trial and understanding the full potential of Annamycin for the treatment of STS lung mets.\"\n19 subjects were enrolled in the Phase 1B portion of the MB107 study. The median number of cycles administered was 2. There were no significant safety concerns or unexpected serious adverse events (SAEs) up to the 390 mg/m2 dose. The recommended Phase 2 dose (RP2D) was defined as 330 mg/m2. The most frequently reported adverse events (AEs) related to Annamycin were in the system organ class of Investigations (decreased platelet counts). There was no evidence of cardiotoxicity as measured by ejection fraction, ...