Press release
Monopar Therapeutics Reports First Quarter 2020 Financial Results and Business Updates
Validive clinical trial design adapted for current COVID-19 pandemic challenges CHICAGO, May 07, 2020 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar
About this update from Monopar Therapeutics Inc.
[{"type":"text","content":"Validive clinical trial design adapted for current COVID-19 pandemic challenges\nCHICAGO, May 07, 2020 (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 first quarter 2020 financial results and business updates.\n First Quarter and Recent Highlights Validive Phase 2b/3 Clinical Trial Monopar, in response to the current COVID-19 pandemic and its effects on clinical trials, has modified the original adaptive design Phase 3 clinical trial to be a Phase 2b/3 clinical trial to better fit the types of trials which can enroll patients in the current environment. The primary endpoint, absolute incidence of severe oral mucositis, remains the same, but the touch points with the healthcare system have been minimized. The Validive program will now consist of a randomized Phase 2b/3 clinical trial anticipated to start in the second half of 2020, which will have an unblinded data readout after the Phase 2b portion (estimated to be in the second half of 2021), and shortly thereafter the Phase 3 portion will commence subject to the Company’s ability to raise additional funding or find a suitable pharmaceutical partner. Camsirubicin Phase 2 Clinical Trial Camsirubicin clinical program continues to make progress with its collaboration with Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcoma cancers, which is sponsoring the approximately 170-patient camsirubicin Phase 2 clinical trial for the treatment of advanced soft tissue sarcoma, anticipated to begin in the second half of 2020. “We are excited to move our clinical development programs forward, especially in light of the challenges that the COVID-19 pandemic has created for many biopharmaceutical companies. Addressing the needs of oncology patients is our highest priority and we look forward to entering the clinic in the second half of this year,” said Andrew Mazar, Ph.D., Monopar’s Chief Scientific Officer. First Quarter Summary Financial Results Results for the Quarter Ended March 31, 2020 Compared to the Quarter Ended March 31, 2019 Cash and cash equivalents as of M...