Proactive Investors - Run By Investors For Investors

CytoDyn announces filing of FDA fast-track application for breast cancer treatment

The target of leronlimab is a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling
A breast cancer procedure
A preclinical study showed a 98% reduction of breast cancer tumor metastasis

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.

DEEP DIVE: CytoDyn presses forward with HIV treatment after Phase 3

“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]

View full CYDY profile View Profile

CytoDyn Timeline

Related Articles

scientist in lab
December 20 2018
Data from Midatech's MTD201 drug has validated the company's Q-Sphera sustained release technology, and other, bigger players are starting to sit up and take note
February 08 2019
“If successful, this platform [AP103] has potential in other genetic skin conditions and beyond”
October 17 2018
The biotech was founded by an investment group led by scientists and driven by a no-nonsense CEO whose stake is more than just business as usual
Copyright ©, 2019. All Rights Reserved - Proactive Investors North America Inc., Proactive Investors LLC

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use