CytoDyn Reports Early Results from First Patient i

CytoDyn Reports Early Results from First Patient in its Phase 1b/2 CCR5+ Metastatic Triple-Negative Breast Cancer Trial

First metastatic triple-negative breast cancer patient showed no detectable circulating tumor cells (CTC) or putative metastatic tumor cells (EMTs) in the peripheral blood. Further, a significant reduction in CCR5 expression was demonstrated on cancer-associated cells after eight weeks of treatment with leronlimab

A second patient with metastatic breast cancer has been enrolled under an emergency use investigational new drug

VANCOUVER, Washington, Dec. 03, 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 additional early Phase 1b/2 clinical trial results evaluating leronlimab (PRO 140) patients with CCR5+ metastatic triple-negative breast cancer (mTNBC). Data from the first patient enrolled show no detectable circulating tumor cells (CTC) or EMTs in the peripheral blood and additional reductions in CCR5 expression on cancer-associated cells at eight weeks. A second patient with metastatic breast cancer has been enrolled in the trial under an emergency use investigational new drug (IND).

The first patient in the open label study was given a weekly injection of leronlimab at 700mg along with carboplatin. The patient was enrolled in the trial with CCR5-positive, mTNBC and naïve to chemotherapy in metastatic setting. The patient was previously exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings.

“The fourth blood sample from the mTNBC patient, drawn following eight weeks of treatment, demonstrates a notably sustained response to leronlimab,” said Bruce Patterson, M.D., chief executive officer of IncellDx. “Other cancer-associated macrophage-like (CAML) cells in the blood sample were found at the lower limits of detection and were also decreased in size. Most importantly, the CAML cells had reduced CCR5 staining compared to samples taken from the patient three weeks earlier, reflecting an ongoing blockade of the CCR5 receptor by leronlimab.”

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, stated: “It is very exciting to see additional preliminary results that demonstrate leronlimab’s potential as a therapeutic option to treat mTNBC. We are also pleased to have enrolled a second patient with metastatic breast cancer under an emergency IND. If the results of the second patient are similarly impressive, we plan to file for Breakthrough Therapy designation before the end of January 2020. We have had many patients contact us for treatment under our expanded access protocol and another hospital has opened enrollment for our mTNBC trial. We look forward continuing our research in furtherance of this clinical development plan.”