Press release
Monopar Announces Encouraging Camsirubicin Phase 1b Trial Update
Patient in 520 mg/m2 cohort, previously unresectable, experienced tumor shrinkage and had tumor resected following camsirubicin treatment 3 of 3 patients in
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"Patient in 520 mg/m2 cohort, previously unresectable, experienced tumor shrinkage and had tumor resected following camsirubicin treatment 3 of 3 patients in the 520 mg/m2 cohort achieved stable disease WILMETTE, Ill., June 01, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer, today announced an update from its currently enrolling multi-center open-label Phase 1b clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS). Background on ASTS and Camsirubicin ASTS is a diverse type of cancer that typically develops in the connective tissue of the body and which has metastasized (spread) or is not amenable to surgery. The average life expectancy from time of diagnosis for patients with ASTS is about 12 to 15 months. Currently, doxorubicin is the first-line standard of care treatment for most types of ASTS. Doxorubicin is one of the most widely used cancer drugs worldwide with FDA approval in ASTS and 13 additional cancer indications. 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). Camsirubicin has been designed to retain the anti-cancer activity while avoiding the irreversible heart damage that is seen with doxorubicin. The hypothesis for camsirubicin is straightforward: modifying doxorubicin in order to reduce cardiac damage could enable higher and longer dosing, resulting in better efficacy and patient outcomes. Updates from Currently Enrolling Phase 1b Clinical Trial One patient at the 520 mg/m2 dose level, unresectable at study entry, was deemed eligible for tumor resection after several cycles of camsirubicin treatment and a corresponding 21% reduction in tumor dimensions. This patient recently underwent surgical resection of the cancer. 100% of patients (3 of 3) at the fourth dose-level (520mg/m2) achieved stable disease, and had either a net reduction or no overall change in tumor size per RECIST 1.1 while on study drug. Phase 1b data continue to show an improvement...