Cytodyn Inc (CYDY)

[ClosetInvestor]

Below is the exact quote from the PR on December 24th, 2020:

“CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company is closing down its Phase 2 trial for acute GvHD.”

The pandemic has slowed enrollment of nearly all of CYDY’s trials (NASH, Cancer. GvHD) but none have been closed down for that reason. And why would a company close a trial because of slow enrollment? Simply keeping the trial open and attempting to enroll patients is not costly. Additionally, why hide this information and at the bottom of an unrelated PR?

The truth is this: leronlimab did not show efficacy in GvHD and the trial was discontinued. The first GvHD trial in 2018 was halted by the DSMC for lack of efficacy after an interim analysis of 10 patients. CYDY at the time stated they would rewrite the protocol and the 1st patient under the new protocol was injected earlier this year. NP never gave updates on the results of the 1st trial not of the patient injected earlier this year, which tells us that leronlimab didn’t work in GvHD. NP released an anecdotal PR on 2 stroke patients so he no doubt would have PRed good results in the GvHD trial.


https://www.cytodyn.com/newsroom/press-releases/detail/272/cytodyn-to-amend-protocol-for-pro-140-phase-2-trial-in-gvhd