It never seems to stop. Another day, more nonsense from everyone’s favorite reverse merger pink sheet Coronacrapper, Cytodyn (CYDY). So just what is Cytodyn hyping today?

After the bell last night, on the 7th of June, the company issued the latest in a long series of breathless press releases (here) touting, this time, an animal study. Eighteen (18) rhesus macaques were given Cytodyn’s “wonder drug” leronlimab and then deliberately infected with SHIV (aka Monkey AIDS) in an intrarectal challenge (aka up the butt). And what do you know? One of the two doses studied seemed to be effective in preventing the transmission of the Monkey AIDS (hard to say for sure, as there was no control group and n=18 is too small to make valid determinations, but hey, this is CYDY, where it’s all about the press releases to keep American and German retail morons excited). Great news for macaques? Not really. Because just a year ago a study was published on a vaccine that keeps macaques safe from infection by SHIV (here).

But The Nadir won’t tell you about that, because the point of press release is to get the retail base excited about the idea of using leronlimab as “PrEP” (Pre-Exposure Prophylactic) for human AIDS. Currently the approved PrEP regimen is a well known combination pill known as Truvada. Cytodyn is trying to hype up the idea of using a weekly or bi-monthly injection of leronlimab instead. Said The Nadir:

“We are eager to build upon these preclinical results describing leronlimab’s utility in HIV prevention by initiating clinical studies for leronlimab as a PrEP treatment. Current PrEP options require a continued daily dosing regimen in order to be effective and are inherently difficult to maintain in the long-term,” said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn. “Coupled with its safety profile, leronlimab could offer a much needed simple and long-lasting preventative treatment option for people at risk of HIV infection,” concluded Dr. Pourhassan.

It is all just warmed-over nonsense, of course, as The Nadir has been doing this since at least 2013! Remember this press release?

Or how about 2019’s PrEP hype (here), which was about a human (not macaque) study to be conducted in Thailand? 

That study, by the way, never happened, but you won’t find a press release anywhere from the company, just this little snippet from a conference call from May 26, 2020:

 

But what if you believe that there is a large, untapped, market for a a long acting injectable PrEP regimen? You will be very pleased to know that while Cytodyn hypes up worthless (see central limit theorem as to why n=18=bullshit) pre-clinical animal studies, there have already been successful studies of other injectable PrEP regimens. Including a very recent Phase 3 study. That was randomized, double-blinded, and controlled. In humans. Over 4500 of them. This study, known as HPTN083, was stopped earlier than planned, in May 2020, for efficacy.

 

Results from that study were also presented yesterday (at the same conference where Cytodyn presented their weaksauce). See the HPTN083 study presentation here to understand how a REAL study (n=4500, 43 sites, actual controls) is done, and what REAL results look like: p<.0005, HR=0.34.

Cytodyn is clearly never going to be the winner in the injectable PrEP space, their much-hyped Thailand study never actually happened and they are still touting animal results. Who will ride the HPTN083 cabotegravir P3 results to victory and all that sweet sweet TAM that comes with it? The maker of cabotegravir is no reverse merger pink sheet piece of trash. It is ViiV Healthcare. The very same joint-venture company (a jv between Pfizer and GlaxoSmithKline) that makes the only approved CCR5 inhibitor, Selzentry aka maraviroc! If CCR5 inhibition was a viable PrEP strategy, don’t you think ViiV would already be on it? Hint: CCR5 inhibition has already been studied for PrEP in 2016, see HPTN069. CCR5 inhibition as PrEP is most likely only viable in combination with other medications, like tenofovir (part of Truvada). This completely eliminates the supposed advantage of not having to take daily pills. 

Pfizer, and GSK (and Gilead maker of Truvada), will continue to own the entire HIV/AIDS market, while Cytodyn cult members will continue to be bamboozled by The Nadir into thinking they are actively building a bright new future and SAVING LIVES! with leronlimab, merely to be passively fleeced (yet again) in the mundane present. 

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