Press release
Monopar Announces First Patient Dosed in Phase 1b Trial Evaluating Camsirubicin for the Treatment of Advanced Soft Tissue Sarcoma
WILMETTE, Ill., Oct. 27, 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., Oct. 27, 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 that the first patient has been dosed in its open-label dose-escalation Phase 1b clinical trial evaluating camsirubicin for the treatment of advanced soft tissue sarcoma (ASTS). “We are very pleased to have dosed our first patient so quickly after trial initiation and so soon following our FDA allowance to proceed in early August. The strong interest and support we are seeing within the oncology community for this study adds to our hopeful excitement and anticipation of the potential impact that escalating doses of camsirubicin may have on improving patient outcomes,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “We are excited to participate in this clinical trial that addresses a high unmet medical need in a cancer which carries a tragic 12 to 15-month life expectancy. There have been no advances in first-line therapies for decades in this patient population, and today’s first camsirubicin treatment in this trial marks an encouraging milestone for the thousands of ASTS patients who may potentially benefit from this drug,” said Dr. Sant Chawla, Principal Investigator, Sarcoma Oncology Research Center in Santa Monica, CA. An estimated 21 patients will be enrolled in the Phase 1b clinical trial, which is active and recruiting in the US. Further information about the camsirubicin 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 previously in ASTS patients in a Phase 1 and a single arm Phase 2 clinical trial. In these studies, no 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 through the use of prophylactic G-CSF. Based on encouraging clinical results to date, the current Phase 1b trial is designed to test camsirubicin at even higher doses than previously administered while using concomitant prophylactic G-CSF to ...