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Of these 2, one subject maintained SD through the end of 6 cycles prior to progressing ~6.2 months after initiating treatment with Annamycin. Of the 14 subjects enrolled in the Phase 2 portion of the trial, 9 (64%) showed stable disease (SD) through 2 cycles, 5 (36%) of whom continued to show SD through 4 cycles, and 2 (14%) showed SD through 6 cycles. In Phase 2, 14 subjects (median # of prior therapies = 3) received at least 2 cycles of Annamycin at 330 mg/m 2. There was no evidence of cardiotoxicity as measured by ejection fraction, strain analyses, ECGs, and cardiac biomarkers including Troponin-I and T. The most frequently reported adverse events (AEs) related to Annamycin were in the system organ class of Investigations (decreased platelet counts). The recommended Phase 2 dose (RP2D) was defined as 330 mg/m 2. There were no significant safety concerns or unexpected serious adverse events (SAEs) up to the 390 mg/m 2 dose. The median number of cycles administered was 2. We look forward to further data readouts from this trial and understanding the full potential of Annamycin for the treatment of STS lung mets."ฤก9 subjects were enrolled in the Phase 1B portion of the MB107 study. "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. "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. The 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.
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