On August 3, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported clearance from the US Food and Drug Administration (FDA) to proceed under its IND with an open-label Phase 1b dose-escalation trial evaluating camsirubicin plus growth factor support (pegfilgrastim) in patients with advanced soft tissue sarcoma (ASTS) (Press release, Monopar Therapeutics, AUG 3, 2021, View Source [SID1234585577]). The Company anticipates dosing the first patient in the trial in the fourth quarter of this year.

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"By giving concomitant growth factor support to overcome the dose-limiting toxicity of this class of drug, we hypothesize camsirubicin could be dosed even higher and longer than doxorubicin, yielding the chance to demonstrate efficacy superiority over doxorubicin," said Octavio Costa, MD, Monopar’s Chief Medical Officer.

"We eagerly await reaching each higher dose level in this trial," said Andrew Mazar, PhD, Monopar’s Chief Scientific Officer. "Camsirubicin is a novel analog of doxorubicin, and doxorubicin is known to work through a dose-dependent mechanism, where higher quantities yield more anti-cancer effect."

"If successful in ASTS, there are 13 other potential cancer indications for camsirubicin where doxorubicin is already FDA-approved," said Chandler Robinson, MD, Monopar’s Chief Executive Officer.