For years now, everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY), has been hyping up the potential for its only product, affectionately referred to as loserlimab, as a treatment for Graft versus Host Disease (GvHD). And as with all things Cytodyn, this has been only a string of ridiculous hype and broken promises.
The status of the GvHD trial is one of the topics in the company’s upcoming webcast on January 6, 2021:
[It should also be noted that there is no mention of the Philippines in this list, which is odd considering all of the hype in recent months. Unless, of course, one knows that all of that hype was easily disproven nonsense.]
As a preview of next week’s circus, let’s take a look at the history of the GvHD trial, and where it actually stands today.
As early as Fall 2015 the company began to hype up GvHD as a potential indication. Press releases were issued in October 2015:
And in mid December 2015:
Interestingly, back in 2015 the company used the proper language. The FDA never “approves” studies, they only “clear” them. Another press release appears in late December 2015:
Yet, in typical Cytodyn fashion, it took The NaDDir* and his klown krew a full four months, mid-April of 2016, to actually launch the study. You can look up the trial information for yourself, at the Clinicaltrials.gov website, but here is the relevant section:
It took them 13 more months to finally find and treat a patient, in mid-May 2017. The company issued a press release stating:
After that, the company was relatively silent about the indication, with the exception of two late 2017 press releases about routine paperwork submissions and trumpeting animal data. [Cytodyn’s behavior around their HIV PrEP study in Thailand follows a similar pattern, big announcements of human trials then nothing but hype around animal data by an outside scientist to hide the fact that the PrEP study never even happened!]
In March 2018, after an interim analysis, the trial was massively modified. You can read the company’s press release about it here.
The press release was scant on details, there was no mention of what the interim analysis actually showed, although we can make some educated guesses based upon the modifications. Naturally, the press release doesn’t mention those specifically, the actual changes could only be found by digging on the clinicaltrials.gov website.
Instead of a proper randomized, controlled, trial the study would now became an open label, unblinded, unrandomized, single arm, collection of anecdotes.
The placebo arm disappears, and the dosage of loserlimab given in the study would increase from 2 injections of 175mg, which would total to 350mg of the drug, to 525mg of loserlimab.
Older, presumably sicker, patients were now being excluded:
All of this suggests that the 350mg dose was utterly ineffective against placebo, so much so that a new, much higher, dose was selected, and the placebo group eliminated to avoid another embarrassment. The modifications were finally accepted in August 2018, and enrollment was able to continue.
It took another 19 months, (a full 24 months after the interim analysis) for Cytodyn to finally treat another GvHD patient (keep in mind this delay was before the convenient excuse of Covid-19 could possible come up.) The company announced in a March 2020 trial update press release:
Throughout 2020 the company continued talking about the indication. Here are some slides from the most recent (October 2020) corporate presentation, available on Cytondyn’s website.
And the company went into greater detail here:
And throughout the year at the bottom of virtually every one of CYDY’s multitude (over 120 year to date) of press releases was this little blurb buried in the boilerplate:
That is, until the December 15th press release when the boilerplate language suddenly changed, and a curious sentence was appended to the usual paragraph about GvHD:
Funny that The NaDDir’s* and his top notch team forgot to edit out the part of the paragraph that states they are currently conducting the study. Even funnier that this Klown Krew blame their failings on Covid-19 when the study has been a disaster, with delay after delay, since it was first announced over 5 years ago!
Happy New Year!
* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping