Press release
Monopar Advances Dosing of Camsirubicin to Higher Level Than Tested In Any Previous Clinical Trial
WILMETTE, Ill., Dec. 08, 2021 (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., Dec. 08, 2021 (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 announced the positive recommendation from its safety review committee to escalate to the second dose level in its camsirubicin Phase 1b trial in patients with advanced soft tissue sarcoma (ASTS). This decision was made following a review of safety data from the patients in the first dose cohort and will allow evaluation of a higher dose level of camsirubicin than has been administered in any prior clinical trial. “Camsirubicin belongs to a class of drugs, anthracyclines, that have repeatedly demonstrated a dose-dependent anti-tumor response,” said Andrew Mazar, PhD, Monopar’s Chief Scientific Officer. “Camsirubicin has already shown potential signs of anti-tumor activity in a traditional all-comer advanced cancer Phase 1 and in a pilot Phase 2 study in ASTS, so the ability to achieve a higher dose than previously used in those studies is an important milestone for the company.” “We are pleased with the swift progress accomplished to date, rapidly moving from regulatory trial allowance to first site activated to clearing the first dose level in only a few months,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “We are eager to continue evaluating progressively escalating dose levels of camsirubicin, which may demonstrate increasing anti-tumor activity.” Further information about this actively enrolling, open-label, dose-escalation Phase 1b clinical trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649. About Camsirubicin Camsirubicin is a novel proprietary analog of the widely used cancer drug doxorubicin. It has been investigated in ASTS patients in a Phase 1 and a single-arm Phase 2 clinical trial. In these studies, no camsirubicin-treated patients developed the irreversible cardiotoxicity common to doxorubicin at higher cumulative doses. The most frequent adverse event observed in the Phase 1 study was neutropenia, which was mitigated in the Phase 2 study using prophylactic G-CSF. Based on encouraging clinical results to date, the current Phase 1b trial is designed to test camsirubicin at progressively higher doses than prev...