![]() Furthermore, the company has submitted a protocol for Phase III registrational trial for the critically-ill population with the U.S. In addition, Leronlimab is being tested in a Phase II investigative trial for COVID-19 Long-Haulers. and is now running a trial in Brazil with an improved trial structure. As a result, the company moved beyond the U.S. These studies did not meet their primary or secondary endpoints except for the secondary endpoint in the critically ill subpopulation. So far, Leronlimab has completed two clinical trials including a mild-to-moderate trial and severe-to-critical trial. This has made Leronlimab a candidate for the treatment of various stages of COVID-19. In infectious diseases, the CCR5 receptor helps modulate immune cell movement to spots of inflammation in the body. The FDA granted Leronlimab Fast Track designation for mTNBC. Accordingly, CytoDyn is running Leronlimab in a Phase II study in mTNBC, and a basket trial of 22 different solid tumor cancers. In mTNBC, Leronlimab eliminated breast cancer metastasis by more than 97% in a murine xenograft model. By blocking CCR5, Leronlimab could moderate tumor metastases. The FDA granted Leronlimab Fast Track designation for combination therapy with HAART for HIVįor cancer, CCR5 is theorized to have a critical part in tumor invasion, metastases, and tumor microenvironment control. It is important to note that Leronlimab displayed fewer side effects and less frequent dosing than contemporary HIV therapies. Leronlimab was able to demonstrate the ability to meaningfully reduce or control HIV viral load in five clinical trials. For HIV, Leronlimab works as a viral-entry inhibitor by binding to CCR5, as a result, guarding healthy T cells against infection of the HIV “R5” subtype. ![]() Leronlimab achieved its primary endpoints in a pivotal trial for combination therapy with HAART for HIV in patients with multi-drug resistance. Thus far, Leronlimab has been tested in 16 clinical trials with more than 1,200 patients in several different indications. Leronlimab is a humanized IgG4 mAb that attaches to the CCR5 receptor, which is important in HIV infection, tumor metastases, NASH, and numerous other diseases or conditions. I intend to review the company’s recent developments and will discuss why I believe these developments verify Leronlimab’s potential to be an essential therapeutic that has a universal application. As a result, I am still bullish on CYDY in both the near term and long term. I believe Leronlimab is making a case to be a unique product that can be safely employed in some of the worst chronic and acute diseases and conditions. CytoDyn is walking into 2022 with numerous prospects in play including HIV programs, metastatic triple-negative breast cancer “mTNBC”, COVID-19 programs, and nonalcoholic steatohepatitis “NASH”. These results are just one of several positive updates coming from the company over the past couple of months. According to CytoDyn, these marks hit their endpoints and are statistically significant. CytoDyn ( OTCQB:CYDY) recently publicized encouraging results from their Part 2 open-label portion of the Phase II NASH clinical trial testing 350 mg weekly dose of Leronlimab, demonstrated an average 80 msec cT1 decrease in half of the patients and a reduction of roughly 50 msec in 80% of patients.
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