Press release
Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments
First Patients Dosed in Camsirubicin Phase 1b Clinical Trial in U.S.Validive® Phase 2b/3 VOICE Trial Cleared to Enroll in Europe andon Track for Reaching
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"First Patients Dosed in Camsirubicin Phase 1b Clinical Trial in U.S.Validive® Phase 2b/3 VOICE Trial Cleared to Enroll in Europe andon Track for Reaching Interim in H1 2022 WILMETTE, Ill., Nov. 12, 2021 (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 third quarter 2021 financial results and summarized recent clinical developments. Recent Clinical Developments Validive Monopar received clearance in multiple European countries to conduct its 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.Monopar continues to actively initiate additional clinical sites in both the U.S. and the EU for the Phase 2b clinical trial, which is on track to reach the interim in the first half of 2022.There remains no FDA-approved prevention or treatment for CRT-induced SOM. Camsirubicin 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.In September 2021, Monopar initiated the Phase 1b clinical trial, and in October 2021, dosed the first patients.Monopar continues to work on activating additional clinical sites in the U.S. for the Phase 1b clinical trial. Results for the Third Quarter Ended September 30, 2021, Compared to the Third Quarter Ended September 30, 2020 Cash and Net Loss Cash and cash equivalents as of September 30, 2021, were $22.3 million. Monopar anticipates that its current cash and cash equivalents will fund: the Phase 2b portion of the VOICE clinical trial; the commencement of the Phase 3 portion of the VOICE clinical trial; and the Phase 1b camsirubicin clinical trial through December 2022. The Company plans to raise additional ...