Press release
Monopar Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Developments
Validive® Phase 2b/3 VOICE Trial Anticipates Go/No-Go Interim Readout by End of Next WeekCamsirubicin Phase 1b Dose-Escalation Trial Now Enrolling 5th
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"Validive® Phase 2b/3 VOICE Trial Anticipates Go/No-Go Interim Readout by End of Next WeekCamsirubicin Phase 1b Dose-Escalation Trial Now Enrolling 5th Dose-Level Cohort (650 mg/m2) WILMETTE, Ill., March 23, 2023 (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 2022 financial results and summarized recent developments. Recent Developments Validive – International Phase 2b/3 Trial, Interim Go/No-go Analysis on Track for End of Next Week The VOICE trial, in planning for a potential positive go/no-go outcome from the interim analysis, continues to enroll patients in the Phase 3 portion of the VOICE trial and add additional clinical sites (now at 81 active sites across the U.S. and Europe).The blinded interim analysis of clinical data from the Phase 2b patient cohort of the trial, to be performed by an independent data monitoring committee, will be used to recommend the Company either continue enrolling the Phase 3 portion of the trial or to stop the trial. This analysis should be completed and reported out by the end of next week. Camsirubicin – Phase 1b Dose-Escalation Trial, Now Enrolling Fifth Dose-Level Cohort Monopar is currently enrolling patients into the fifth dose-level cohort (650 mg/m2), which is nearly 2.5x the highest dose evaluated in any prior camsirubicin clinical trial (265mg/m2).Phase 1b data to date show an improvement in median progression free survival from what was observed in the prior camsirubicin Phase 2 trial (265 mg/m2). This is supportive of our dose-response hypothesis with camsirubicin.To date, no drug-related cardiotoxicity has been observed with camsirubicin treatment as evaluated by the industry standard left-ventricular ejection fraction (LVEF). This compares favorably to the well-documented dose-restricting cardiotoxicity experienced with doxorubicin, the current first-line treatment for advanced soft tissue sarcoma (ASTS).75% of camsirubicin patients in this trial have experienced no hair loss. Of the 25% with any hair loss, only 8% experienced >50% hair loss and only 17% experienced low grade hair loss. This compares favorably to the approximately 50% ...