In a statement, the company said data from the first patient enrolled show no detectable circulating tumor cells (CTC) 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) process, CytoDyn said.
READ: CytoDyn has multiple shots on goal with its flagship drug leronlimab as cure for HIV, various cancers
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, triple-negative breast cancer and naïve to chemotherapy in a metastatic setting. The patient was previously exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings.
“It is very exciting to see additional preliminary results that demonstrate leronlimab’s potential as a therapeutic option to treat mTNBC,” said CEO Nader Pourhassan.
He said that if the results of the second patient under an emergency IND are similarly impressive as the first patient, CytoDyn plans 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,” he added. “We look forward to continuing our research in furtherance of this clinical development plan.”
CytoDyn, based in Vancouver, Washington, is developing leronlimab to battle multiple diseases. The company has filed an IND application and a Phase 2 clinical trial protocol with the US Food and Drug Administration for leronlimab to treat patients with non-alcoholic steatohepatitis (NASH).
Leronlimab has also already completed nine clinical trials and been given to 800 patients in HIV treatment programs, without a single drug-related serious adverse event. CytoDyn is also exploring leronlimab's use in the treatment of inflammatory conditions and autoimmune diseases.
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