Monopar Therapeutics Inc. (NASDAQ: MNPR) has doses the first patient in the dose-escalation, open-label phase 1b clinical study evaluating camsirubicin in advanced soft tissues sarcoma (ASTS) treatment.
Monopar to enroll 21 ASTS patients
Chandler Robinson, Monopar CEO, said, “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.”
The company plans to enroll 21 patients in the Phase 1b clinical study that is currently active and enrolling in the US.
Principal Investigator, Sarcoma Oncology Research Centre in Santa Monica, California, Dr. Sant Chawla, said, “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.”
Current study to evaluate higher doses of camsirubicin
Camsirubicin is a new patented derivative of doxorubicin, a commonly used oncology medication. A Phase 1 and a single-arm Phase 2 clinical trial in ASTS patients were conducted earlier. No patients suffered the irreversible cardiotoxicity associated with doxorubicin at higher cumulative dosages in these studies. Neutropenia was the most common adverse event in the Phase 1 study, which was minimized in the Phase 2 study by using prophylactic G-CSF. The present Phase 1b trial will investigate camsirubicin at even greater dosages than previously given while employing concomitant prophylactic G-CSF to prevent neutropenia, based on good clinical results to date.
