Press release
Monopar Announces Camsirubicin Clinical Program Update - Improved Side Effect Profile Seen to Date Compared to Doxorubicin
WILMETTE, Ill., Feb. 14, 2023 (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., Feb. 14, 2023 (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 following update on its currently enrolling open-label Phase 1b camsirubicin Maximum Tolerated Dose (MTD) trial in patients with advanced soft tissue sarcoma (ASTS): Monopar has opened enrollment for the fifth dose level cohort, at an increased dose of 650 mg/m2, which is nearly 2.5x the highest dose evaluated in any prior camsirubicin clinical trial. To date, no drug-related cardiotoxicity has been observed with camsirubicin treatment as evaluated by the industry standard left-ventricular ejection fraction (LVEF). This compares favorably to the well-documented dose-restricting cardiotoxicity experienced with doxorubicin treatment, the current first-line treatment for ASTS. Only 17% of camsirubicin patients in the trial have experienced low grade hair loss; another 8% have experienced >50% hair loss. This compares favorably to the approximately 50% of doxorubicin treated patients in recent ASTS clinical trials reporting some amount of hair loss, with the majority of these patients experiencing >50% hair loss. Only 8% of camsirubicin patients in the trial have experienced low grade mild oral mucositis. This compares favorably to the roughly 35-40% of doxorubicin treated patients in recent ASTS clinical trials that experienced mild-to-severe oral mucositis. In addition to the initial Sarcoma Oncology Research Center clinical trial site in Santa Monica, CA, Monopar recently welcomed a second clinical trial site with Dr. Lee Cranmer and the Sarcoma Clinic at the Fred Hutchinson Cancer Center/University of Washington in Seattle, WA. “We are thrilled to partner with Monopar in exploring camsirubicin in patients facing ASTS. So far, camsirubicin has demonstrated a favorable safety profile at up to the 520 mg/m2 dose level assessed to date,” said Dr. Cranmer. “Further escalation of camsirubicin dosing will allow us to confirm its favorable safety profile and explore preliminary evidence of camsirubicin’s clinical activity in advanced sarcoma patients. While only randomized trials will be able to confirm superiority of camsirubicin over doxorubicin, camsirubicin pr...