CytoDyn Inc (OTCMKTS:CYDY) announced its first step into the cancer space on Tuesday, revealing that it had injected its first patient, who has an aggressive type of breast cancer, with its leronlimab treatment.
The patient is being treated under emergency investigational new drug (IND) regulations of the US Food and Drug Administration (FDA), the biotech firm said in a statement.
This emergency treatment is in addition to the firm's ongoing Phase 1b/2 clinical trial on leronlimab for treating metastatic triple-negative breast cancer (mTNBC), for which it was granted fast-track status by the FDA in May this year.
"Today marks a milestone in our company’s history, a first step into the oncology space,” CytoDyn CEO Dr Nader Pourhassan told investors.
"It is equally important to note that leronlimab has already completed eight successful clinical trials and has been dosed in over 800 patients in our HIV programs, without any drug-related serious adverse events (SAEs).
"With results from multiple preclinical studies in various cancer indications, including mTNBC, we are optimistic about the potential of leronlimab to provide a new therapeutic option to many patients," he added.
Leronlimab blocks CCR5, a cellular receptor, which has found to be important in HIV infection, tumor metastases, and other diseases including nonalcoholic fatty liver disease (NASH).
The FDA has granted 'fast track' designation for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer (mTNBC).
In afternoon trading on the OTC in New York, shares in CytoDyn were 1.1% higher at $0.445.
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