Press release
Monopar Announces Encouraging Clinical Data from Ongoing Camsirubicin Phase 1b Trial
WILMETTE, Ill., Nov. 16, 2022 (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., Nov. 16, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today released encouraging data from its ongoing Phase 1b open-label clinical trial of camsirubicin in advanced soft tissue sarcoma patients. The data is displayed in the poster Monopar will be presenting later today at the 2022 Connective Tissue Oncology Society (CTOS) Annual Meeting, which is bringing together the world’s leading sarcoma specialists. Monopar has made the poster available on its website at the following link: https://www.monopartx.com/pipeline/Camsirubicin/mnpr-201-001-clinical-trial. Camsirubicin Background Doxorubicin is one of the most widely used cancer drugs worldwide. Unfortunately, although higher doses of doxorubicin are known to be more effective at treating cancer, the risk of irreversible heart damage increases with the cumulative dose and limits the lifetime amount that a patient can receive. As a result, even if patients are responding, they discontinue doxorubicin treatment typically after only 6 to 8 cycles (~6 months or less). The hypothesis behind camsirubicin is straightforward: molecularly modifying doxorubicin in order to reduce cardiac damage could enable higher and longer dosing, resulting in better patient outcomes. The prior exploratory clinical studies of camsirubicin in cancer patients showed the potential to treat patients with high doses for a year or longer. The preclinical and exploratory clinical studies also showed no irreversible heart toxicity with camsirubicin. The current Phase 1b study is designed to evaluate whether camsirubicin can be dosed even higher than previously achieved and continue for longer than doxorubicin. Camsirubicin Phase 1b Clinical Trial Design The Phase 1b trial is an open label dose escalation design to determine the maximum tolerated dose of camsirubicin in advanced soft tissue sarcoma (ASTS) patients. The average life expectancy of ASTS patients at diagnosis is about 12 to 15 months, and doxorubicin is the current first-line standard of care treatment for most types of ASTS. The starting dose for the first three patients was set at 265 mg/m2, the highest dose previously tested in the exploratory cli...