logo-loader
viewCytoDyn Inc.

CytoDyn reports positive results from first patient in triple-negative breast cancer drug leronlimab trial

In a good sign, the patient in the clinical trial showed significant reduction in circulating tumor cells and reduced tumor size

CytoDyn - CytoDyn Inc reports positive results from first patient in triple-negative breast cancer drug leronlimab trial
Leronlimab works as an inhibitor of CCR5, a protein that plays a role in tumor invasion and metastasis

CytoDyn Inc (OTCMKTS:CYDY) said Tuesday that the first patient of a new Phase 1b/2 clinical trial for its metastatic triple-negative breast cancer (mTNBC) treatment, leronlimab, reported encouraging initial results. 

In a statement, the Vancouver, Washington-based late-stage biotechnology company said circulating tumor cells in the patient’s blood decreased significantly after leronlimab therapy at both two-week and five-week time points. 

Furthermore, a reduction in CCR5 expression on presumed metastatic tumor cells was evident, reported the company. 

READ: CytoDyn's triple-negative breast cancer drug leronlimab given to first patient in clinical trial

“We are excited to be involved with CytoDyn in evaluating the efficacy of leronlimab in metastatic triple-negative breast cancer," said IncellDx CEO Bruce Patterson.

Efficacy against the most aggressive tumor type

“These results at both two-week and five-week time intervals post-leronlimab therapy indicate initial efficacy against this most aggressive tumor type. Moreover, the reduction of CCR5 expression on EMT cells may prove to be significant, as high CCR5 expression is believed to be crucial for metastases,” he added.

The treatment of mTNBC with leronlimab in the Phase 1b/2 trial is in addition to metastatic breast cancer patients treated with leronlimab under an emergency use investigational new drug.

The results of the trial will determine the company’s regulatory fate, particularly whether it will seek Breakthrough Therapy Designation and accelerated approval with the US Food and Drug Administration.

Fast Track designation for mTNBC

Leronlimab has been granted Fast Track designation for metastatic triple-negative breast cancer by the FDA, based on a greater than 98% reduction of metastatic tumor volume in a murine xenograft model.

Leronlimab was previously granted Fast Track designation for mTNBC based on its metastatic tumor reduction rate of more than 98% in mice and for part of a combination therapy in patients with HIV.

“Today marks yet another significant milestone in our company’s history, advancing CytoDyn’s clinical development in oncology. Although these are early results in our first patient, we are encouraged by the reduction in both circulating tumor cells and tumor size,” said CytoDyn CEO Nader Pourhassan.

The CytoDyn boss said the company’s safety record with leronlimab, and preclinical results in multiple oncology trials in various cancer indications, solidifies its vision to explore oncology indications.

“We are optimistic about the opportunity to provide a potential new therapeutic option for the women that are diagnosed with invasive breast cancer each year in the United States,” said Pourhassan.

“We wish to thank the women who have agreed to participate in our trials and will endeavor to provide each of them with clinical benefit," he added.

CytoDyn is developing leronlimab (PRO 140) to battle multiple diseases. Leronlimab has already completed nine clinical trials and been given to 800 patients in HIV treatment programs, Pourhassan said, without a single drug-related serious adverse event.

The drug itself works as an inhibitor of CCR5, a protein that plays a role in tumor invasion and metastasis. Blocking CCR5 has been shown to reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Quick facts: CytoDyn Inc.

Price: 0.305 USD

OTCQB:CYDY
Market: OTCQB
Market Cap: $118.42 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of CytoDyn Inc. named herein, including the promotion by the Company of CytoDyn Inc. in any Content on the Site, the Company receives from said...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Full interview: CytoDyn offers update on leronlimab following encouraging...

CytoDyn Inc. (OTCQB:CYDY) CEO Nader Pourhassan and IncellDx Inc CEO Dr Bruce Patterson offer an update on leronlimab's mechanism of action (MOA) in regards to its ongoing cancer trials, specifically in metastatic breast cancer. Dr Patterson says the amazing thing about CCR5 is how it plays...

4 days, 19 hours ago

3 min read