Press release
Monopar Therapeutics Reports Second Quarter 2021 Financial Results and Recent Business Updates
Camsirubicin Phase 1b Clinical Trial Anticipated to Start in the U.S. in Q4 2021Validive® Phase 2b/3 VOICE Trial on Track for Reaching Interim Analysis in H1
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"Camsirubicin Phase 1b Clinical Trial Anticipated to Start in the U.S. in Q4 2021Validive® Phase 2b/3 VOICE Trial on Track for Reaching Interim Analysis in H1 2022 WILMETTE, Ill., Aug. 12, 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 second 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 successfully reached its target of 20 activated clinical trial sites for the Phase 2b portion of the trial. Monopar plans to activate additional clinical trial sites, potentially including sites outside of the U.S. There is no FDA-approved prevention or treatment for CRT-induced SOM. The VOICE trial is on track for reaching interim analysis in the first half of 2022. Camsirubicin and MNPR-202 and Related Analogs The U.S. Food and Drug Administration cleared Monopar to proceed under its Investigational New Drug (IND) application with an open-label Phase 1b dose-escalation clinical trial evaluating camsirubicin plus growth factor support (pegfilgrastim) in patients with advanced soft tissue sarcoma (ASTS). Monopar anticipates dosing the first patient in the fourth quarter of 2021.Monopar entered into a collaboration agreement with the Cancer Science Institute of Singapore, one of Asia’s premier cancer research centers, at the National University of Singapore (consistently ranked as one of the world's top universities) to evaluate the activity of MNPR-202 and related analogs in preclinical models of multiple types of cancer. MNPR-202, a camsirubicin analog, was designed to retain the same potentially non-cardiotoxic backbone as camsirubicin but is modified at other positions which may enable it to be efficacious in certain cancers that are resistant to camsirubicin and doxorubicin. MNPR-202 and related analogs are covered under a newly issued U.S. composition of matter patent (US10,450,340). MNPR-101 RIT and Related Compounds Monopar and NorthStar Medical Radioisot...