We continue to wait for The NaDDir*, and his klown krew, at everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY) to actually reveal the top line results from the CD12 study of loserlimab for Severe-to-Critical Chinese Coronavirus Disease. With all of this extra time, we will continue our look back at Cytodyn’s long history of broken, empty, promises. Failing to deliver is a bit of a specialty for the klown krew.
Many readers are aware of Cytodyn’s laughable promises of using their drug as a monotherapy for HIV treatment. Why laughable? Because even if you take the company at its word (we don’t), loserlimab only blocks one strain of HIV (there are two strains). This is why the existing, approved, drug on the market, maraviroc, which does exactly what Cytodyn’s drug does, is not used for monotherapy. There are other drugs already on the market, like Trogarzo, that block both strains. And there are other drugs further ahead in development from Viiv and others, including a once-every-six-month subcutaneous treatment, from Gilead (GILD). Read more about those here.
For over four years Cytodyn has been running its Phase 3 HIV monotherapy trial, often referred to as CD03. Details can be found here. The trial started in August 2016, although the company has been eerily silent about it for a little over two years.
For quite some time, Cytodyn press releases carried a little bit of boilerplate about the trial at the bottom. Here is an example from the 2nd of Sept 2020:
Just a few weeks later, on the 20th of September, the boilerplate changed:
Sometime in mid-September 2020, the CD03 trial has been completed. Yet five months later there is still no press release announcing results, no 8k has been filed with the SEC, and the klown krew could not even update Clinicaltrials.gov records. Seems strange for a Phase 3 trial of a supposedly revolutionary treatment. The only clues we have about how the trial had been faring are from an interim look at the data. The company issued a press release in November 2018 stating:
Unlike 2020’s CROI debacle, which we looked at a few days ago, this time the poster actually was available at the conference. You can look it up here, and download the poster for yourself here. What you will find is, well, not good. The interim look at CD03 caught all of the patients in the 350mg dose group (which is actually 2 injections of 175mg each), the 525mg group (3 injections x 175mg) and only some of the 700mg dose group (yes…even more injections!). While The NaDDir* loves to mention the handful of patients that have done well on conference calls, does he ever mention the huge numbers of patients that failed on loserlimab monotherapy? See the boxes entitled Virologic Failure. Here is a hint for biotech neophytes, failure is bad:
Well even though monotherapy is singularly unimpressive, at least they have that safety record to tout, right? It is true that injection site reactions appear to be uncommon. The same cannot be said about other Adverse Events (AEs).
Anywhere from 48% to 75% of subjects experienced at least one AE. Somewhere between 3.5% and 8.4% of patients experienced a Serious Adverse Event (SAE). One might notice the Cytodyn never reveals exactly what these AEs are, nor their grade. The bulls might say, “oh, but the company says ‘None of the reported SAEs were definitely or probably related to PRO 140.’ that means it is safe.” According to whom? The company? The company’s hired gun CRO? The investigators who may have tremendous conflicts? What of the possibly related SAEs and the unlikely but possible ones?
Of course the easiest way to know the CD03 trial failed is just to look at the boilerplate of recent Cytodyn press releases, like the one from earlier this week. Notice what the company says about the CD02 trial versus the CD03 trial (and the CD10 trial for good measure). Here’s CD02:
And for fun, CD10:
What a difference that one little word in the boilerplate makes. The late 2019 pivot to cancer, and the 2020 pivot to Chinese Coronavirus Disease makes all the more sense. Will we ever see the real, complete, CD03 results? Will we ever see the real, complete, CD10 results? And will we ever see the real, complete CD12 results? Or will we just see the next pivot?
* Spelled Thusly For A Double Dose of That Sweet Sweet Stock Pimping