CytoDyn Files a Phase 2 Protocol with the FDA for Leronlimab (PRO 140) and Regorafenib as a Combination Therapy for Metastatic Colorectal Cancer
Download as PDFAugust 08, 2019 6:00am EDT
VANCOUVER, Washington, Aug. 08, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the filing of a Phase 2 protocol with the FDA for a combination therapy of leronlimab and Regorafenib in patients with metastatic colorectal cancer (mCRC). The study is to be conducted by lead principal investigator, John L. Marshall, M.D., Director, The Ruesch Center for the Cure of GI Cancers Frederick P. Smith Endowed Chair, Chief, Hematology and Oncology Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C.
This is a single arm study with 30 patients designed to test the hypothesis that the combination of leronlimab, administered as a subcutaneous injection, and Regorafenib, administered orally, will increase progression-free survival in patients with CCR5-positive metastatic colorectal cancer.
“This is the third clinical program that CytoDyn has underway in the oncology space,” stated, CytoDyn President and CEO, Nader Pourhassan, Ph.D. “We recently announced the first injection in our clinical trial using leronlimab to treat metastatic triple-negative breast cancer (rmTNBC), under the supervision of Jacob Lalezari, M.D. In addition, our Phase 1b/2 trial using leronlimab in treatment-naïve mTNBC patients is under the supervision of Massimo Cristofanilli, M.D. professor of Medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine.”
“With results from multiple pre-clinical studies in various cancer indications, including MBC and mCRC, we are optimistic about the potential of leronlimab to provide a new therapeutic option for individuals diagnosed with invasive cancer each year in the United States. We again thank the patients who have agreed to participate in our trials and endeavor to provide each of them with clinical benefit,” concluded Dr. Pourhassan.
