And then came covid...
“We have completed our safety review of your application and have concluded that you may proceed with your proposed clinical investigation of Protocol number CD08_mCRC, entitled, “A Phase II Study of Leronlimab (PRO 140) in combination with Regorafenib in Patients with CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC),” as stated in the letter from the FDA.
The Phase 2 study 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 of a patient with leronlimab to treat metastatic triple-negative breast cancer (mTNBC), through the expanded access program 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.”