Replies to post #733 on CytoSorbents Corporation (CTSO)

[vinovista]

Succinct!

A big Bravo Zulu

[dr_lowenstein]

Hoggey, you stated: “Some Medasorb detractors suggest cytokine removal and/or breaking the cytokine storm are insignificant remedies for treating sepsis.”. I suggest you reread my post, here is what I said:
“While it is quite possible that using hemoperfusion may reduce cytokine levels and that would be a good thing, the literature is quite convincing that the disease itself is much too complex for such a "miracle" cure.”

The papers that you cite all refer to hemoperfusion as adjunctive therapy, which of course it will be if demonstrated to be useful in the clinical setting.

Thank you though for the papers you cite. It is interesting that you would use an article dealing with another direct competitor of medasorb. The Hirasawa paper uses the Toray non-polymyxin B filter “A PMMA membrane hemofilter (Hemofeel CH-1.0, Toray Medical Co. Ltd., Tokyo, Japan) was placed in the blood circuit to adsorb cytokines in the circulating blood.”

Also, thanks for pointing out the Kellum paper. The interesting thing about this rat study is the 7 day survival 52% vs 28% for controls. Impressive preclinical data yes, a miracle cure NO. (IMO)

[hoggey1]

As these articles reveal, a number of experts have recognized that infection alone doesn't cause death in severe sepsis and septic shock. "Endotoxin doesn't kill by itself, but kills by inducing cytokine storm that then leads to multi-organ failure and death" (Phillip Chan MD, PhD).

You can see from reading these studies in the previous post, that the concept of using blood purification to treat sepsis is not a new idea; however, with materially positive results from MSBT's clinical trials, it may well become the next breakthrough, life saving, medical technology to make front page headlines.

By some estimates, up to 50% of the patients worldwide with sepsis still die on the current standard treatment. The standard treatment has focused on using antibiotic therapy to treat the infection. Unfortunately, it would seem the standard is flawed considering how the micro-organisms causing the infection continue to evolve into drug resistant bugs.

And to continue focusing on fighting the infection with antibiotics, means it will be necessary to continue finding and developing new antibiotics to fight these new resistant strains. This would seem doomed to failure since antibiotics are expensive to develop and many drug companies don't want to spend the money in developing new antibiotics because they're only used for short periods of time (as compared to medicine for chronic conditions) and with resistance on the rise, it's likely only a short time before the new antibiotic runs into a resistant strain of superbug.

So even if using hemofiltration to break the cytokine storm didn't have the potential to become a "miracle cure" for treating sepsis, we'd have to ask ourselves about the wisdom of relying on antibiotic therapy to treat this indiscriminant killer.

To quote Dr Chan, "There are many animal studies that demonstrate that if you block the recognition of endotoxin by the immune system it can break cytokine storm and reduce mortality."

http://seekingalpha.com/instablog/501192-frank-the-gerbil/36549-email-from-dr-chan-provides-valuable-insight-in-to-cytosorb-s-role-in-combating-cytokine-storm

"The key problem is that in an infection it is very difficult to intervene and antagonize endotoxin early enough to prevent it from triggering a cytokine production. Typically by the time the patient seeks medical treatment in the hospital the window of opportunity to antagonize endotoxin has long passed. At that point, patients are dealing with the consequences of cytokine storm and serious infection. Once cytokines begin to be mass produced, cytokines trigger the production of more cytokines in the absence of endotoxin. SO FOR ANTIENDOTOXIN STRATEGIES TO WORK THEY NEED TO BE ADMINISTERED EARLY."

This aspect alone could be the one factor making the MSBT device a standard adjunct therapy to the standards of care for treating sepsis. If the outcome from the trials is materially positive, it’s not unreasonable to think that this device could indeed become the next MIRACLE CURE, EVEN IF IT’S ONLY AN ADJUNCTIVE TREATMENT FOR SEPSIS.

And as Dr Chan pointed out in the BiomedReports interview: “There have been no serious device related adverse events in more than 500 human treatments, more than 150 of which have actually been in patients with sepsis.”

Furthermore the device is flexible to change or modification if or when the data and/or models suggest any adjustments are necessary to improve results. That’s the beauty of having a new technology in development and that is; "it's in development."

If the outcomes from the trials are positive enough to warrant regulatory approval, I’m confident the company will be working round the clock to find perfection in treating sepsis. While this doesn't meet the definition of a "miracle cure" just yet, it's quite possibly the most promising new treatment for sepsis that's currently in development. We should know one way or another by the end of this year.

And regardless if it's only an "adjunctive" miracle cure, the potential market for the device is enormous. By some estimates, the number of cases in Europe is over 1.5 million compared to only 1 million in the United States.

http://biomedreports.com/articles/most-popular/27800-has-medasorb-found-the-holy-grail-to-treat-severe-infections.html

Worldwide it's estimated that there are over 18 million case each year. At $500 per day and a seven days of therapy, that's potentially $3,500 per patient on MSBT's device. Times??? You do the math.