Gene therapies – futile and deadly – The train wreck continues

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Vigilant Fox has been spreading some very fake news lately:

That is extremely unfortunate. This clickbait has been spread around the internet and I have seen coverage in numerous languages, all repeating the same junk headline about a review paper which is NOT A STUDY! No scientific experiment was conducted to produce that paper. It was a fantasy story consisting of several unsupported assertions and cartoons piled on top of each other. It didn’t even qualify for a reasonable hypothesis!

I debunked the siRNA drug Onpattro irresponsibly promoted by Vigilant Fox as an “off-switch” for c-19 injection injuries in this article.

I am planning to publish more on Anylam’s other RNAi drugs, which are just as bad. stay tuned.

No, you cannot have an “off switch” for a poison brew with a dozen known and many more unknown mechanisms of poisoning, that cannot be made to any manufacturing specification. Much less when the “off switch” consists of more of the same unpredictable poison accompanied by a lifetime use of steroids and antihistamines! Dr. McCullough should have enough sense to disassociate himself from this science-themed pornography… or at least tell his boss Foster Coulson to reign-in the Vigilant Fox’s click bait productions.

In other news:

Pfizer’s Duchenne muscular dystrophy gene therapy failed to meet the primary and key secondary endpoints in a Phase 3 study, pointing to a bleak future for the program.

The gene therapy failed to significantly improve motor function at one year in boys with Duchenne, measured using a 17-item scale that evaluates various aspects of mobility called the North Star Ambulatory Assessment. The therapy also did not significantly improve secondary endpoints such as 10-meter run/walk velocity and time-to-rise-from-floor velocity compared to placebo.

“Pfizer will continue to closely monitor all participants enrolled in the study and is evaluating appropriate next steps for the program,” the company said Wednesday in a statement.

Known as CIFFREO, the study enrolled 99 boys aged 4 through 7 with Duchenne muscular dystrophy, according to the federal clinical trials database. The participants received Pfizer’s fordadistrogene movaparvovec or placebo.

There have been two patient deaths in Pfizer’s Duchenne gene therapy clinical studies. In May, Pfizer disclosed that a boy enrolled in a Phase 2 study for the therapy passed away, and it was investigating the patient’s death. As a result, the company paused the administration of the gene therapy to boys who had originally been in the placebo arm of the Phase 3 study. In 2021, Pfizer disclosed a boy in a Phase 1b study of the gene therapy died and later said he “had more advanced disease with underlying cardiac dysfunction.”

The FDA granted accelerated approval last June to Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy for boys aged 4 to 5.

The only approved gene therapy for muscular dystrophy on the market to date is Sapepta’s $4M/course of treatment. This drug failed its clinical trials, but was nevertheless “approved” by Peter Marks, over-ruling the objections of the FDA reviewers who were against it. I reported on this a year ago.

Neither failure of treatment nor increased deaths stop the Spaceship of Fools that gene therapy is! Despite consistent failures to produce any medicinal value, the FDA will expand the indication for Sarepta’s product:

Within the narrow group of patients eligible for Elevidys, demand has been high. The FDA is expected to decide by June 21 on whether to expand the eligible population based on mixed results from a confirmatory study.

Of course the demand is high!! Doctors poisoning terminally ill boys for $4M a pop are not stupid. Famous quote by Robert Malone quoting his friend Steve Hatfill – “they are going to die anyway!” So, what’s the big deal, folks? $cience needs to experiment on somebody! For the greater good!

In other news, Gilead, the maker of hospital murder weapon remdesivir has a newly gene-therapy caused $4.9B whole in their pipeline, having recently terminated their monoclonal antibody program for cancer due to increased deaths.

The pipeline update marked a muted end to a molecule that was once central to Gilead’s cancer plans. In 2020, Gilead paid $4.9 billion to acquire Forty Seven, chiefly for magrolimab, to expand its portfolio beyond cell therapies. Analysts saw the antibody as a potential “pipeline in a product” that could unlock opportunities across a wide range of blood cancers and solid tumors.

Things began to go wrong early in 2022 when the FDA imposed a partial clinical hold in response to an “apparent imbalance” in adverse reactions between study arms. Gilead’s woes deepened as the antibody failed phase 3 trials and was linked to patient deaths, culminating in February’s one-two punch.

Gilead was far from the only company attracted by the potential to treat cancer by targeting CD47. One company challenged it for Forty Seven’s signature, another two were interested in striking a partnership deal for magrolimab and Pfizer paid $2.3 billion for Trillium.

Couldn’t have happened to nicer people!

 

Source: Gene therapies – futile and deadly. The train wreck continues.


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