Press release
Monopar Therapeutics Reports Third Quarter 2020 Financial Results and Business Update
Validive® Phase 2b/3 Clinical Trial on Track to Start Before Year-endIssuance of New Patents For ValidiveCamsirubicin Phase 2 Clinical Trial to Start Late
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"Validive® Phase 2b/3 Clinical Trial on Track to Start Before Year-endIssuance of New Patents For ValidiveCamsirubicin Phase 2 Clinical Trial to Start Late 2020/Early 2021\n WILMETTE, Ill., Nov. 12, 2020 (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 third quarter 2020 financial results and business update. Third Quarter Business Update Lead Product Candidate Validive Monopar’s Phase 2b/3 clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy for oropharyngeal cancer (OPC) is on track to commence before year-end. There currently is no FDA-approved prevention or treatment for radiation-induced SOM. The U.S. Patent and Trademark Office allowed patent claims for Monopar’s lead product candidate, Validive, covering “Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy.” The recently issued patents would provide protection should Monopar determine in the future to conduct additional Validive development and commercialization activities related to adverse side effects of chemotherapy beyond OPC. Camsirubicin The Phase 2 clinical trial of camsirubicin is anticipated to begin at the end of 2020 or in early 2021. Monopar has partnered with Grupo Español de Investigación en Sarcomas (GEIS), which will lead the multi-country, randomized, open-label Phase 2 clinical trial evaluating camsirubicin head-to-head against standard-of-care doxorubicin in patients with advanced soft tissue sarcoma (ASTS).The trial will begin with a dose escalation “run-in” prior to the randomization portion of the trial. The primary endpoint of the trial will be progression-free survival, with secondary endpoints including overall survival, response rate, and incidence of treatment-emergent adverse events. MNPR-101 Forward progress was made on the Monopar/NorthStar collaboration focused on developing a novel treatment for severe COVID-19 by partnering with 1) IsoTherapeutics Group, LLC to develop and manufacture radioimmunotherapeutics targeting uPAR (uPRITs), 2) Aragen Biosc...