The results of the trial will determine the company’s regulatory fate, particularly whether it will seek Breakthrough Therapy Designation and accelerated approval with the US Food and Drug Administration, CytoDyn said in a statement on Saturday.
Leronlimab was previously granted Fast Track designation for mTNBC based on its metastatic tumor reduction rate of more than 98% in mice and for part of a combination therapy in patients with HIV.
In the now underway clinical trial, circulating tumor cells will be evaluated in each patient every three weeks.
“Today marks a crucial milestone in our company’s history, launching CytoDyn into clinical development in the oncology space,” CEO Nader Pourhassan said in a statement. “We are optimistic about the potential of leronlimab to provide a new therapeutic option for the roughly 37,000 women that are diagnosed with triple-negative breast cancer each year in the United States.”
Leronlimab has already completed nine clinical trials and been given to 800 patients in HIV treatment programs, Pourhassan said, without a single drug-related serious adverse event.
The drug itself works as an inhibitor of CCR5, a protein that plays a role in tumor invasion and metastasis. Blocking CCR5 has been shown to reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer.
Shares of CytoDyn surged 12% on Monday to $0.38.
—Updated to include closing price—
Contact Andrew Kessel at [email protected]
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