Press release
Monopar Therapeutics Reports First Quarter 2021 Financial Results and Recent Business Updates
First Patient Dosed in Validive® Phase 2b/3 VOICE Clinical TrialCamsirubicin Run-in Clinical Trial Now Planned to Start in 2H 2021Potential Utility Reported
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"First Patient Dosed in Validive® Phase 2b/3 VOICE Clinical TrialCamsirubicin Run-in Clinical Trial Now Planned to Start in 2H 2021Potential Utility Reported for MNPR-101 as Imaging Agent in Cancer Surgery WILMETTE, Ill., May 13, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (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, today announced first quarter 2021 financial results and recent business updates. Recent Business Updates Validive Monopar’s Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC) dosed its first patient in February 2021 and is actively recruiting patients and initiating additional clinical trial sites. There is no FDA-approved prevention or treatment for CRT-induced SOM.The U.S. Patent and Trademark Office (USPTO) allowed a new patent with claims for Validive covering “Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy.” This patent expands coverage on the potential uses of Validive in cancer patients beyond earlier allowed claims limited specifically to the prevention and/or treatment of oral mucositis in patients receiving CRT. Camsirubicin and Novel Analogs Based on the Company’s current inability to gain regulatory approval to initiate the camsirubicin Phase 2 clinical trial in Spain, Monopar is evaluating alternatives to move the dose escalation run-in clinical trial forward outside of Spain. Monopar believes that it will be able to initiate the run-in clinical trial in the second half of 2021 in the U.S. or another country.The USPTO allowed a new patent with claims covering compositions of matter for a novel family of camsirubicin analogs (2-pyrrilino camsirubicins). This patent expires in 2038, not including any patent term extensions. The patent broadens Monopar’s camsirubicin portfolio and covers a pipeline of compounds designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin along with the potent broad-spectrum antitumor activity of doxorubicin. Preclinical evidence suggests ...