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CytoDyn wins FDA approval for Phase 2 Study of leronlimab and Regorafenib as combo therapy

The 30-patient study tests the hypothesis that a combination of injected leronlimab and Regorafenib taken orally will increase survival in patients with metastatic colorectal cancer

CytoDyn - CytoDyn’s wins FDA approval for Phase 2 Study of leronlimab and Regorafenib as a combo therapy
Leronlimab blocks CCR5, a cellular receptor, which has found to be important in tumor metastases

CytoDyn Inc (OTCMKTS:CYDY) revealed Monday that the US Food and Drug Administration has given the greenlight to its Phase 2 protocol for a combination therapy of leronlimab and Regorafenib to treat patients with metastatic colorectal cancer

In a statement, the Vancouver, Washington-based late-stage biotechnology company said the FDA had completed its safety review and allowed the company to proceed with its proposed clinical investigation. As a result, the study will be conducted by lead principal investigator John L Marshall, who is an expert in drug development for colon cancer. He is also the chief of the Division of Hematology-Oncology at MedStar Georgetown University Hospital, in Washington.  

The 30-patient study is designed to test the hypothesis that a combination of injected leronlimab and Regorafenib taken orally will increase progression-free survival in patients with CCR5-positive metastatic colorectal cancer.

READ: CytoDyn files Phase 2 protocol with FDA for use of leronlimab and regorafenib as combo therapy for metastatic colorectal cancer

Leronlimab blocks CCR5, a cellular receptor, which has found to be important in HIV infection, tumor metastases, and other diseases including non-alcoholic fatty liver disease (NASH).

“This is the third clinical program that CytoDyn has underway in the oncology space,” said CytoDyn CEO, Nader Pourhassan in a statement.

“With results from multiple pre-clinical studies in various cancer indications … we are optimistic about leronlimab’s potential to provide a new therapeutic option for individuals diagnosed with invasive cancer each year in the United States,” he added.

CytoDyn recently injected its first patient, who has an aggressive type of breast cancer, with its leronlimab treatment.

This 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.

Dr Pourhassan said that with results from multiple pre-clinical studies in various cancer indications, the company is optimistic about the potential of leronlimab to provide a new option for people diagnosed with invasive cancer.  

“We again thank the patients who have agreed to participate in our trials,” concluded Pourhassan.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

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Price: $0.39

Market: OTCQB
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