Monopar Therapeutics Reports First Quarter 2023 Financial Results and Recent Developments

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[{"type":"text","content":"Camsirubicin Phase 1b Dose­Escalation Trial Enrolling 5th Dose­Level Cohort (650 mg/m2) MNPR-101 RIT Shows Promising Imaging and Therapeutic Preclinical Study Results\nWILMETTE, Ill., May 11, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical­stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced first quarter 2023 financial results and summarized recent developments. Recent Developments Camsirubicin – Phase 1b Dose­Escalation Trial, Currently Enrolling Fifth Dose­Level Cohort Phase 1b data to date show an improvement in median progression free survival in patients with advanced soft tissue sarcoma (ASTS) from what was observed in the prior camsirubicin Phase 2 trial (265 mg/m2). This is supportive of our dose­response hypothesis with camsirubicin. Additionally, one of the three patients in the 520 mg/m2 dose-level cohort recently went from having what was initially determined to be an unresectable cancer to, after several cycles of camsirubicin treatment and a corresponding 21% reduction in tumor dimensions, being determined to be resectable. This changed the course of treatment for this patient, who recently did undergo surgical resection of the cancer. Monopar is currently enrolling patients into the fifth dose­level cohort (650 mg/m2), which is nearly 2.5x the highest dose evaluated in any prior camsirubicin clinical trial (265mg/m2). To date, no drug­related cardiotoxicity has been observed with camsirubicin treatment as evaluated by the industry standard left ventricular ejection fraction (LVEF). This compares favorably to the well­documented dose­restricting cardiotoxicity experienced with doxorubicin, the current first­line treatment for ASTS. 75% of camsirubicin patients in this trial have experienced no hair loss. Of the 25% with any hair loss, only 8% experienced >50% hair loss and only 17% experienced 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 8% of camsirubicin patients in the trial have experienced low grade, mild oral mucositis. This compares favorably to t...

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