- Monopar Therapeutics Inc MNPR opened enrollment for the fifth dose level cohort in the open-label Phase 1b camsirubicin Maximum Tolerated Dose trial for advanced soft tissue sarcoma (ASTS), a diverse type of cancer that typically develops in the body’s connective tissue.
- The cohort dose is at an increased dose of 650 mg/m2, nearly 2.5x the highest dose evaluated in any prior camsirubicin clinical trial.
- The company said that no drug-related cardiotoxicity has been observed with camsirubicin treatment.
- It compares favorably to the well-documented dose-restricting cardiotoxicity experienced with doxorubicin treatment, the current first-line treatment for ASTS.
- 17% of camsirubicin patients in the trial have experienced low-grade hair loss; another 8% have experienced over 50% hair loss, versus approximately 50% of doxorubicin-treated patients reporting some amount of hair loss, with the majority of these patients experiencing >50% hair loss.
- 8% of camsirubicin patients in the trial have experienced low-grade mild oral mucositis compared to the roughly 35-40% of doxorubicin-treated patients.
- “So far, camsirubicin has demonstrated a favorable safety profile at up to the 520 mg/m2 dose level assessed to date,” said Dr. Cranmer.”
- EF Hutton writes that having established proof-of-concept in sarcoma, camsirubicin could be developed in another dozen cancer indications, where doxorubicin is still the backbone of treatment.
- It reiterates the Buy rating and a price target of $24.
- Price Action: MNPR shares are down 13.7% at $3.16 on the last check Tuesday.
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