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Moleculin Concludes Phase 1b and Opens Recruitment in Phase 2 Clinical Trial of Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases
– Preliminary Phase 1b data demonstrated clinical activity, defined as stable disease or better – Company determines RP2D to be 360 mg/m2 and will begin Phase
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"– Preliminary Phase 1b data demonstrated clinical activity, defined as stable disease or better\n– Company determines RP2D to be 360 mg/m2 and will begin Phase 2 recruitment\n– Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma \nHOUSTON, July 28, 2022 /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 announced it has completed the safety review of the fourth cohort in a dose escalation clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases, thus concluding the Phase 1b portion of its U.S. Phase 1b/2 clinical trial. Preliminary results from the study continue to document clinical activity for Annamycin in the treatment of STS. The safety review committee (SRC) has deemed the dose of 390 mg/m2 to be safe after conclusion of the fourth cohort. Notwithstanding that there was safety at this dose level, tolerability issues present at the 390 mg/m2 dose level caused delays in follow-on cycles and the reduction of subsequent doses, suggesting that a Recommended Phase 2 Dose (RP2D) below 390 mg/m2 was warranted.\n\n \n \n \n \n \n \n\n \nWith this in mind and with the recommendation of the SRC, the Company has determined that the RP2D will be 360 mg/m2 for the first three subjects in the Phase 2 portion of the study. The SRC will then review the clinical safety data at this dose and determine whether the RP2D should be further reduced to 330 mg/m2 prior to proceeding with the additional 22 subjects. In addition to continuing to assess safety, including gathering additional information about short-term side effects and possible risks, this Phase 2 portion of the study will also explore the efficacy of Annamycin as a single agent for the treatment of subjects with STS lung metastases for whom prior chemotherapy has failed, and for whom new chemotherapy is considered appropriate.\nIn the Phase 1b portion of the study, 15 subjects were enrolled and treated per the protocol in four cohorts to determine the maximum tolerable dose and/or the RP2D. Each cohort had three subjects, except for the fourth cohort, which (per the protocol) was expanded to six subjects after a...