CytoDyn Inc (OTCMKTS:CYDY) said Monday that it has filed an application with the Food and Drug Administration seeking fast-track designation for its injectable antibody for patients with metastatic-triple negative breast cancer.
The biotech company said a preclinical study of its drug candidate leronlimab showed a 98% reduction of breast cancer tumor metastasis after seven weeks. The FDA, according to CytoDyn, recently cleared its investigational new drug (IND) application to initiate a Phase 1b/2 study for the addition of leronlimab, also known as PRO 140, to existing therapies for metastatic triple-negative breast cancer.
The target of leronlimab is CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling, according to Vancouver, Washington-based CytoDyn.
“The sustained reduction in breast cancer metastatic spread in these preclinical studies with leronlimab is consistent with a growing understanding that CCR5, the target of leronlimab, plays an important role in the process of cancer spread by metastasis,” Dr Richard G. Pestell, the company’s chief medical officer, said in a statement.
The FDA’s fast-track designation is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.
The FDA has granted a fast-track designation for leronlimab, also known as PRO 140, as a combination therapy with highly active antiretroviral therapy for HIV-infected patients. The company has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected, treatment-experienced patients.
CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a related biologics license application in 2019.
The company is conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.
Shares of the company traded at $0.50 in Monday’s OTC markets trading.
Contact Dennis Fitzgerald at [email protected]