Press release
Monopar Provides Encouraging Camsirubicin Clinical Data Update
WILMETTE, Ill., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"WILMETTE, Ill., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer, today provided an update from its currently enrolling multi-center open-label Phase 1b clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS). Both patients treated to date at the 650 mg/m2 dose level have experienced tumor size reductions – of 18% and 20% respectively – after the first two cycles of camsirubicin treatment. Both patients are set to receive additional cycles of camsirubicin treatment, as well, which may result in further tumor size reduction. The Phase 1b clinical trial data is continuing to support Monopar’s dose-response hypothesis with camsirubicin. The best response seen prior to the current 650 mg/m2 dose level was at the immediately prior dose level (520 mg/m2), which was a 21% reduction in tumor size in a patient after receiving six cycles of camsirubicin treatment. This patient’s cancer was unresectable at study entry, but after the tumor size reduction, became eligible and the patient underwent successful surgical removal of their cancer with clear margins. Furthermore, all three patients at the 520 mg/m2 dose level achieved stable disease and had either a net reduction or no overall change in tumor size per RECIST 1.1 while on study drug. Additionally, no drugrelated cardiotoxicity has been observed in the trial to date as evaluated by the industry standard left ventricular ejection fraction (LVEF), and no toxicities have been experienced by any patient that have required expanding the size of a dose cohort. Further, 71% of camsirubicin patients have experienced no hair loss, and only approximately 14% have experienced >50% hair loss, with the remainder having low grade hair loss. This compares favorably to the approximately 50% of doxorubicin treated patients in recent ASTS clinical trials reporting some amount of hair loss, with the majority of these patients experiencing >50% hair loss. Only 14% of camsirubicin patients in the Phase 1b trial have experienced mild-to-severe oral mucositis. This compares favorably to the roughly 35-40% of doxorubicin-treated patients in recent ASTS clinical trials that experienced mild-to-severe oral mucositis. ASTS is a deadly cancer with inadequate t...