On January 18, 2023 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, reported the positive recommendation from its safety review committee to advance to the fifth dose level (650 mg/m2) in its camsirubicin Phase 1b trial in patients with advanced soft tissue sarcoma (ASTS) (Press release, Monopar Therapeutics, JAN 18, 2023, View Source [SID1234626330]). This decision was made following a review of safety data from the patients in the first four dose cohorts.
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"Clearance to go to this higher dose level is an important milestone for the trial as this class of drugs is known to have dose-dependent anti-tumor activity," said Chandler Robinson, MD, Monopar’s Chief Executive Officer. "We continue to see a favorable safety profile compared to doxorubicin, and the Phase 1b data to-date shows an improvement in median progression free survival from what was observed in the prior camsirubicin Phase 2 trial (265mg/m2). We are looking forward to evaluating the 650 mg/m2 dose level, which is nearly 2.5x higher than the highest dose evaluated in any prior camsirubicin clinical trial."
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 previously 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 from prior clinical trials, the current Phase 1b trial is designed to test camsirubicin at progressively higher doses than previously administered while using concomitant prophylactic G-CSF to prevent neutropenia.
About Soft Tissue Sarcoma
Soft tissue sarcomas (STS) are a diverse type of cancer that typically develop in the connective tissue of the body. According to the American Cancer Society, in 2021, an estimated 13,460 new STS cases were diagnosed in the U.S. alone, and about 5,350 people will not survive their disease. These tend to be the advanced cases; those with sarcomas that are unresectable and/or have metastasized. The average life expectancy from time of diagnosis for those patients with advanced disease (ASTS) is about 12 to 15 months. Doxorubicin is the current standard of care in the 1st-line setting for ASTS, and has been for decades, since there have been no 1st-line therapeutic advancements that have improved overall survival for this patient population.