CytoDyn Inc (OTCQB:CYDY), a late-stage biotechnology company, revealed Friday that it has filed a request with the US Food and Drug Administration (FDA), for a preliminary meeting to discuss positive new clinical data supporting its aim to win Breakthrough Therapy status for its lead drug leronlimab (PRO 140) in treating metastatic triple-negative breast cancer (mTNBC).
The FDA had previously granted Fast Track designation to leronlimab for the treatment of metastatic triple-negative breast cancer.
On March 12, the Vancouver, Washington-based company reported that the FDA had actually recommended such a meeting to provide preliminary advice prior to resubmission of a Breakthrough Therapy designation request.
READ: CytoDyn says coronavirus patients treated with leronlimab show initial improvements after three days
Meanwhile, the late-stage biotechnology company said that concurrently with its Phase 1b/2 trial for mTNBC and expanded access studies for metastatic breast cancer, it is also conducting a Phase 2 trial with leronlimab for 22 solid cancer tumors.
Metastatic triple-negative breast cancer, an aggressive subtype, has a poor prognosis. In addition, metastatic breast cancer is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options.
The company’s Phase 1b/2 study involves monitoring of circulating tumor cells (CTC), epithelial mesenchymal transition in tumor metastasis (EMT), and cancer-associated microphages like cells (CAML), every 21 days during the treatment phase.
“We are extremely encouraged by the test results from these patients and continue to keep the FDA current on therapeutic benefit demonstrated by leronlimab for multiple cancer indications,” said CytoDyn CEO Nader Pourhassan in a statement.
CytoDyn is developing leronlimab (PRO 140) to treat different types of diseases. Leronlimab has already been granted Fast Track status by the FDA for the treatment of HIV in combination with the “cocktail” known as highly active antiretroviral therapy (HAART).
Leronlimab has completed nine clinical trials and has been given to 800 patients in HIV treatment programs, without a single drug-related serious adverse event.
The company has also filed an IND application and a Phase 2 clinical trial protocol with the FDA to treat patients with NASH — damage caused by a build-up of fat in the liver.
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