VANCOUVER, Washington, Nov. 12, 2019 – 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 it has received approval from the Institutional Review Board (“IRB”) for leronlimab to be administered to patients with triple-negative breast cancer (“TNBC”) under a compassionate use, which is also known as expanded access program.
This program will allow TNBC patients who are not eligible under the ongoing Phase 1b/2 clinical trial to receive leronlimab (PRO 140). Under this protocol, patients with locally recurrent or metastatic triple-negative breast cancer who had progressed within six months or less on latest chemotherapy will receive leronlimab (PRO 140) combined with a treatment of physician’s choice.
The compassionate use or expanded access program is a potential pathway for patients with an immediately life-threatening condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. An IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects pursuant to regulations of the U.S. Food and … Read the rest