In June 2019, Monopar signed a collaboration agreement with Grupo Español de Investigación en Sarcomas (GEIS) to develop camsirubicin in patients with advanced soft tissue sarcoma (ASTS). GEIS is an internationally renowned non-profit organization focused on the research and development of drugs for sarcomas. Monopar plans to commence a Phase 1b, dose escalation run-in clinical trial in the U.S. or another country in the second half of 2021. Following completion of the Phase 1b clinical trial, Monopar anticipates that GEIS will be conducting a multi-country, randomized (1:1), open-label Phase 2 clinical trial evaluating camsirubicin head-to-head against doxorubicin in the 1st line setting, in patients with ASTS. Enrollment for the GEIS-sponsored clinical trial is will include approximately 170 ASTS patients. The primary endpoint of the trial will be progression-free survival, with secondary endpoints that will include response rate and overall survival. Camsirubicin has been granted Orphan Drug Designation in both the U.S. and EU.

Orphan Drug Designation

Learn more about the European Commission’s Orphan Drug Designation of camsirubicin for the treatment of soft tissue sarcoma

Orphan Drug Designation