CytoDyn's triple-negative breast cancer drug leronlimab given to first patient in clinical trial
CytoDyn Inc (OTCMKTS:CYDY) said its metastatic triple-negative breast cancer treatment, leronlimab, has been given to the first patient of a new Phase 1b/2 clinical trial.
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, CytoDyn said in a statement on Saturday.
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.
In the now underway clinical trial, circulating tumor cells will be evaluated in each patient every three weeks.
READ: CytoDyn wins FDA approval for Phase 2 Study of leronlimab and Regorafenib as combo therapy
“Today marks a crucial milestone in our company’s history, launching CytoDyn into clinical development in the oncology space,” CEO Nader Pourhassan said in a statement. “We are optimistic about the potential of leronlimab to provide a new therapeutic option for the roughly 37,000 women that are diagnosed with triple-negative breast cancer each year in the United States.”
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 Andrew Kessel at [email protected]
Follow him on Twitter @andrew_kessel
Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/903769/cytodyn-s-triple-negative-breast-cancer-drug-leronlimab-given-to-first-patient-in-clinical-trial-903769.html
Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.
"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
Please Help Support BeforeitsNews by trying our Natural Health Products below!
Order by Phone at 888-809-8385 or online at https://mitocopper.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomic.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomics.com M - F 9am to 5pm EST
Humic & Fulvic Trace Minerals Complex - Nature's most important supplement! Vivid Dreams again!
HNEX HydroNano EXtracellular Water - Improve immune system health and reduce inflammation.
Ultimate Clinical Potency Curcumin - Natural pain relief, reduce inflammation and so much more.
MitoCopper - Bioavailable Copper destroys pathogens and gives you more energy. (See Blood Video)
Oxy Powder - Natural Colon Cleanser! Cleans out toxic buildup with oxygen!
Nascent Iodine - Promotes detoxification, mental focus and thyroid health.
Smart Meter Cover - Reduces Smart Meter radiation by 96%! (See Video).