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

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

CytoDyn - CytoDyn files a Phase 2 protocol with the FDA for leronlimab and regorafenib as a combo therapy for metastatic colorectal cancer
Leronlimab blocks CCR5, a cellular receptor, which has found to be important in tumor metastases

CytoDyn Inc (OTCMKTS:CYDY) revealed Thursday that it has filed a Phase 2 protocol with the US Food and Drug Administration 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 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, single arm study is designed to test the hypothesis that a combination of leronlimab administered as an injection, and regorafenib taken orally, will increase progression-free survival in patients with CCR5-positive metastatic colorectal cancer.

READ: CytoDyn marks major milestone for its leronlimab drug with first step into field of 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,” CytoDyn CEO Nader Pourhassan said in Thursday's 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.”

On Tuesday, CytoDyn revealed that it had 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.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

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Price: $0.43

Market: OTCQB
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Full interview: CytoDyn sees 'strong result' in leronlimab dose escalation...

CytoDyn Inc (OTCMKTS:CYDY) CEO Dr Nader Pourhassan tells Proactive the biotech's HIV monotherapy dose escalating trial with its flagship drug leronlimab (PRO 140) topped expectations. Dr Pourhassan says patients receiving 525 mg achieved a 'strong result' with a 94% response rate. 

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