Press release
Monopar Therapeutics Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Program Developments
Validive® Phase 2b/3 VOICE Trial Continues Adding Sites in the U.S. and Europe Camsirubicin Phase 1b Dose-Esclation Trial Clears 2nd Dose Level and is Now
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"Validive® Phase 2b/3 VOICE Trial Continues Adding Sites in the U.S. and Europe Camsirubicin Phase 1b Dose-Esclation Trial Clears 2nd Dose Level and is Now Enrolling 3rd Dose-Level Cohort WILMETTE, Ill., March 24, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced fourth quarter and full-year 2021 financial results and summarized recent program developments. Recent Program Developments and Highlights Validive – International Phase 2b/3 VOICE Clinical Trial, Actively Recruiting Validive is a novel mucobuccal tablet formulation for clonidine that has been designed to provide for prolonged and enhanced local delivery of clonidine to the regions of oral mucosal radiation damage in patients being treated for oropharyngeal cancer.Monopar received clearance in the U.S. and multiple European countries to conduct its Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) (NCT04648020 / EudraCT No. 2021-000999-11) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer.The VOICE trial now has 44 active clinical trial sites in the U.S. and Europe, continues to open additional sites globally, and is on track to reach the interim analysis in mid-2022. Based on findings extracted from public reporting of recently completed SOM trials, Monopar is presently evaluating potential enhancements to and exact timing of the interim analysis.There is no FDA-approved prevention or treatment for CRT-induced SOM. Camsirubicin – Phase 1b Dose-Escalation Trial, Actively Recruiting Camsirubicin, a propriety doxorubicin analog, has been engineered specifically to retain the anticancer activity of doxorubicin while minimizing the toxic effects on the heart.In August 2021, Monopar received clearance from the U.S. Food and Drug Administration to proceed under an Investigational New Drug (IND) application with an open-label Phase 1b dose-escalation clinical trial evaluating camsirubicin plus growth factor support (pegfilgrastim/G-CSF) in patients with advanced soft tissue sarcoma (ASTS) (NCT 05043649).First patient was dosed in October 2021.Monopar is curren...