Monopar Therapeutics announces camsirubicin clinical program update

Monopar Therapeutics 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. To date, no drug-related cardiotoxicity has been observed with camsirubicin treatment as evaluated by the industry standard left-ventricular ejection fraction. Only 17% of camsirubicin patients in the trial have experienced low grade hair loss; another 8% have experienced greater than50% 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. 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 provides hope that we may finally be able to supersede doxorubicin, a drug in use since its approval in 1974, despite its serious drawbacks. Monopar’s continuing efforts to improve ASTS therapy also demonstrate their commitment to changing the treatment landscape for ASTS patients, a population with well-recognized and serious unmet need."