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Moleculin Announces First Subject Enrolled and Dosed in Phase 1b/2 Clinical Trial of Annamycin for the Treatment of Sarcoma Lung Metastases
- Annamycin granted Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma lung metastases - Interim data expected in
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"- Annamycin granted Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma lung metastases\n - Interim data expected in the second half of 2022\n\n\nHOUSTON, June 21, 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 announced it has commenced enrollment and dosed the first subject in its U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases. \n\n \n \n \n \n \n \n\n \nSoft tissue sarcomas are the most common form of sarcoma, accounting for an estimated 130,000 incident cases per year worldwide. While many sarcomas can be addressed through surgical removal, it is estimated that as many of STS sarcomas will eventually metastasize to the lungs, where treatment can become more challenging. Recently published animal data suggests that the efficacy of the current standard of care chemotherapy (doxorubicin) may be limited due to its inability to accumulate sufficiently in the lungs. The use of doxorubicin and other currently approved anthracyclines for STS lung metastases is further limited due to their inherent cardiotoxicity, which limits the amount of anthracycline that can be given to patients. \n\"We are pleased to have commenced patient enrollment and dosing in this important program evaluating Annamycin, which we believe has the potential to address the limitations with current treatment options for STS lung metastases. Our team is commited to driving continued progress for the development of Annamycin. We look forward to getting the trial well-underway toward interim data and potentially address the unmet medical needs in the treatment of these highly resistant tumors,\" commented Walter Klemp, Chairman and CEO of Moleculin.\nThe Phase 1b/2 study is a 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 and in Phase 2 will explore the efficacy of Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate. A minimum of 3 subjects for each dosing coh...