Breast Cancer Trial Shows Significant Reduction in

Breast Cancer Trial Shows Significant Reduction in Circulating Tumor Cells (CTC) and Reduced Tumor Size

https://www.cytodyn.com/newsroom/press-releas...metastatic
Breakthrough Therapy designation filing possible if more patients show similar positive results

VANCOUVER, Washington, Nov. 11, 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 encouraging initial results from the first patient in a Phase 1b/2 clinical trial with metastatic triple-negative breast cancer (“mTNBC”). Circulating tumor cells (“CTC”) in the patient’s blood decreased significantly after leronlimab therapy at both two-week and five-week time points. Furthermore, a reduction in CCR5 expression on presumed metastatic tumor cells was evident.

“We are excited to be involved with CytoDyn in evaluating the efficacy of leronlimab in mTNBC," stated IncellDx CEO, Bruce Patterson, M.D. “These results at both two-week and five-week time intervals post-leronlimab therapy indicate initial efficacy against this most aggressive tumor type. Moreover, the reduction of CCR5 expression on EMT cells may prove to be significant , as high CCR5 expression is believed to be crucial for metastases.”

The treatment of mTNBC with leronlimab in this Phase 1b/2 trial is in addition to metastatic breast cancer (“MBC”) patients treated with leronlimab under an emergency use IND . Results from both of the ongoing trials in MBC will dictate the Company’s regulatory pathway, including the potential to seek Breakthrough Therapy designation and accelerated approval with the U.S. FDA for the use of leronlimab in MBC. Leronlimab has been granted Fast Track designation for mTNBC by the FDA based on a greater than 98% reduction of metastatic tumor volume in a murine xenograft model.

“Today marks yet another significant milestone in our Company’s history, advancing CytoDyn’s clinical development in oncology. Although these are early results in our first patient, we are encouraged by the reduction in both CTC and tumor size. Our safety record with leronlimab, and preclinical results in multiple oncology trials in various cancer indications, solidifies our vision to explore oncology indications. We are optimistic about the opportunity to provide a potential new therapeutic option for the women that are diagnosed with invasive breast cancer each year in the United States. We wish to thank the women who have agreed to participate in our trials and will endeavor to provide each of them with clinical benefit," stated CytoDyn President and CEO, Nader Pourhassan, Ph.D.