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Moleculin Announces Completion of Enrollment in U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB107)
– Data readouts expected before year end – Previously reported preliminary efficacy data on its Phase 1B/2 clinical trial with Annamycin in monotherapy
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"– Data readouts expected before year end \n– Previously reported preliminary efficacy data on its Phase 1B/2 clinical trial with Annamycin in monotherapy treatment of STS lung mets with >60% of the subjects exhibiting stable disease after two cycles of treatment\n– Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma\nHOUSTON, Sept. 21, 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 cancers and viruses, today announced the completion of enrollment in the Phase 2 portion of the Company's U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107). Subjects who had stable disease at time of study discontinuation will continue to be followed for progression free response and overall survival.\n\n \n \n \n \n \n \n\n \n\"The completion of enrollment for our MB107 study marks an important milestone for our STS clinical development program. We remain very encouraged by the preliminary data we have seen in the MB107 trial and look forward to gaining additional insight in Annamycin's ability to treat STS lung mets as the opportunity now shifts to data readouts,\" commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. \"Since many of the patients enrolled into this trial have not yet completed all of their scheduled follow-up examinations, the data from this trial are not complete. However, based on the data demonstrated to date, we believe that the median progression free response of greater than 60%, despite the patients in this study having received multiple prior chemotherapy regimens, exceeds what one would expect. Importantly, we believe this level of progression free response exceeds that of existing approved second line therapies and that Annamycin has the potential to be a meaningful treatment option for the treatment of STS lung mets. We look forward to further additional updates on this trial in the fourth quarter of this year.\"\nThe Company plans to present a more in-depth review of the topline data on progression free survival, progression free response, overall survival, and other data on this study prior to this year-end. Additiona...