Staph Protein A

staphproteina.com

This Domain is owned by Dr. Craig Wiesenhutter.

My goal for this web site is to describe some of the history concerning staph protein A (SpA), the science and theory behind it, and discuss any new data or information concerning SpA as it becomes available.

UpDate Febuary 15th, 2018

I have reread my rant below. I still stand by all I have said there. I actually have a lot more to say about it, so stay tuned.

But back to Protalex. I am unable to elaborate, but clinicians who deal with a patient, sometimes for many years, learn things about that patient. Let it be said that the doctors taking care of these ITP patients in this trial have indeed cared for these patients for many years.

Rumor has it that these investigators have experienced several things in this trial, in respect to the efficacy of SpA for the treatment of ITP, that suggest significant efficacy not documented by the protocol defined definition of a response.

I for one, as a clinical investigator who has often treated patients in trials for over 30 years, understand this comment quite clearly.

I would like an opportunity to speak directly with these investigators about this. Perhaps Protalex will make that possible? You see, unless such claims are judged by others than the likes of me, they are meaningless. Anyway, I'm open to any invitations.

Oh, the company is talking about increasing the frequency of treatments with SpA. Good idea. You see, the animal data possibly is limiting how high a dose they can give per dose. But the frequency of administration is not effected. Very Very good idea. Twice a week for three weeks followed by once a week for nine more weeks. Now there's the ticket. And there's data to prove it.

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UpDate Febuary 8th, 2018

Let’s get this out into the open. I admit it, I’m biased, greatly biased for the success of Staph Protein A. That’s why I have this website.

It’s not because I own stock, I don’t, I’ve never own stock in this company, nor do any significant others. And for lots of reasons. (Stupid. I guess. But as you will soon hear, this drug is my most important claim to fame in my life, and I just don’t want to ruin it because I could have made millions of dollars buying it).

But that’s the point. Look at the data, and my references. In short, I’m the guy that discovered SpA. No question. Check it out.

With that said, I’ve been thinking about what I would do, and what I would say if I was Protalex right now with the data I know about from the ITP trials.

True, one out of six responses compared to the past, isn’t what you’d want, if you looked at SpA as just another drug. But think about it. All the drugs for ITP now, and for that matter, all the drugs that have been approved for the treatment of RA, cost $4,000 or more per month.

Here you have a drug that shows very clear, definite responses in one of six incredibly recalcitrant patients. No question there so far.

Here is a drug, unlike Prednisone, or splenectomy for god sakes (I had a patient die from a splenectomy for ITP) that has very few serious, if any side effects. I have given hundreds of SpA infusions to patients without any significant side effects from it. Here is a drug that costs less money to produce than it costs to make the ampules it comes in. I have dealt with three young patients with ITP, while at the USC Los Angeles County Medical center, who all died in a week from complications of ITP. If one of these patients would have responded to SpA at that time, and if SpA had saved their live, I would to this day be singing SpA’s praises for that.

I now know, from what I'm witnessing at the medical conferences that I go to, that doctors in general are rising up in disgust, looking at the exorbitant prices for drugs like Humira, >$4,000 a month, even though there are biosimilars. Many doctors are now talking about what was recently reported by amazon, and Berkshire, and what these incredibly powerful people intend to to to remove this horrible tapeworm that's currently eating patients, and doctors, this tapeworm that does nothing but feed the middle men etc.

Check out Dr. Roy Fleishmanns debate at the last ACR about biosimilars (when I get a spare minute, I'll post the link here), his wonderful presentation is online, clearly showing that all the extra money that is stemming from the huge investment in development of the biosimilaqrs isn’t going to the patient, or the doctors that are infusing it, but to the middle creepy men who did nothing but intercalcate themselves in such a sleezy fasion for nothing but greed, and the fact that they could do it and get away with it (hello congress, Hello senators, hello president T, you guys could give us a little help here. I think that now, with the wave of disgust against them by so many people, It will end up helping you guys too).

All of us rheumatologists have since then risen up to this atrocity, and now we all are looking, seeking a cheaper drug. We will now go for the cheaper drug, like the new forteo drug for instance that cost 40% less.

Yeah, stock owners, the days when the jerks that raise drug prices from 3K to 4 K and beyond every three months, are now going to be big losers because of guys like me who will point them out as the jerks they are.. I’ll write about this more soon. But mark my words, I see the tide of change here.

But for now, Protalex is in the perfect position to take advantage of all the Dr. hate for big pharma at this moment. Trust me, I feel the hate at every meeting I go to and it's growing incredibly fast.

And if Protalex markets this drug, half way reasonably, Say it cost them $120 a month, and they charge 1K a month, not a bad mark up for any reasonable human being to make, then they will be simply loved by all people. Incredibly loved and it will go viral. And they and you will make a lot of money for their trouble, and do mankind a whole hell of a lot of good in the process. Such a simple thought. Craig Wiesenhutter 2/8/2018

UpDate Febuary 1st, 2018

Okay. I'm listening. I've downloaded the most recent Protalex slides from their website. https://www.protalex.com/ and I studied the changes that protalex made since their original slide collection was posted carefully.

My take, steming from the slides that I've read from 16 to 18 or so, is that there has been one "defined" responder for each of the last five cohorts, with each cohort representing an increase in dose. That's one responder out of six patients treated for each cohort, i.e that equal a 17% response. The last cohort was at 18 ug per kilogram.

Okay, I've been asked to call the people at Protalex to ask them "What will it take for the next cohort, i.e. 24 ug/kg to make a deal with big pharma???? What percentage response will it take? "

One in six or more? Well, by history, and yes these patients are very refractory as compared to the past patients included in research trials and publications, but by history, you need 3 out of 6, 50% or better. I just don't know how to add in this "refractory factor" which is simply quite nebulous.

I don't need to call the people at protalex about this, they can talk to you to answer this question, and the questions I ask below.

Number one, and most importantly, why was there not a dose respone with this drug with these doses given, i.e why is there not a better response per dose???

My guess is that this drug has been incredibly underdosed from the get go.

This drug, given at the right dose, ten times or a hundred times this little pittlely dose given now, could do wonders.

There are easy ways to verify what I say. Go to Germany now and test the patients treated with the current approved SpA column from Fresenius that uses a column of SpA plus loosly bound SpA which is then washed away and repleated again. This method is bound to lead to a huge "loss" of SpA into the patient.

I have a lot more to say about all this, but I'll keep it simple for now.

But what I do know, beyond a shadow of a doubt, if that SpA, if given a chance, if it is treated right, it will blow all other competition away!!!

I have no disclosures.

I and my significant others have never bought the stock.

UpDate December 2017

What is happening with Protalex and PRTX-100 now ???

Three patients showed a significant platelet elevation, whereas 14 patients did not. Not so very good, I'm afraid.

After their first publication of their data, and complaints I assume, they represented their data as something to do with standard deviations. I treat patients with ITP. If their platelet count is 5,000, they are at great risk of dying. I want a treatment that brings their platelet count back up to 25,000 or better yet, 50,000. I could care less if their treatment raised the platelet count 3 standard deveiations from the original count, the patient is still at great risk of dying and that type of response is clinically meanless.

There are over three million Americans with RA, and only a very small number of patients with ITP.

"Go where you can do the most good, and in the end it will pay the most dividends". Craig Wiesenhutter

I have no disclosures about this. I'm just trying to help SpA reach it's potential, which is HUGE HUGE HUGE HUGE!!!!!!!

The most popular clinical textbook of medicine at this time is most likely the digital textbook, UpToDate.

From UpToDate

"●Responses to ITP therapy can be defined as follows: •Response – A response is defined as a platelet count above 30,000/microL and at least doubling of the baseline platelet count. •Complete response – A complete response is defined as a platelet count ≥100,000/microL."

●For all patients with a new diagnosis of ITP and any clinically important bleeding, we recommend ITP-specific therapy, rather than observation, to reduce the risk of worsening bleeding complications. We also suggest ITP-specific therapy for patients with a new diagnosis of ITP and a platelet count of less than 20,000 to 30,000/microL even in the absence of bleeding symptoms, because the thrombocytopenia may be persistent and become more severe. A platelet count above 30,000/microL provides a margin of safety since severe bleeding typically does not occur unless the platelet count is less than 10,000 to 20,000/microL. Some patients with platelet counts between 20,000 and 30,000/microL may be managed safely with observation and close monitoring."

Therefore, a significant clinical response in ITP to any drug, including a new drug, would require an increase in the platelet count to 30,000 or greater. A complete response would be an increase in platelet count to 100,000, or greater. References to several other studies use the same definitions as these for clinical responses. There is no mention of using a “standard of deviation” definition.

UpDate April 2017

What is happening with Protalex and PRTX-100 now ???

I believe that Protalex has decided to no longer pursue any development of SpA for the treatment of Rheumatoid Arthritis (RA), and I believe that would be a big mistake.

I treat RA patients every day, more than three hundred patients. So many of these patients continue to do poorly, even given these nine so called miracle drugs available today. I believe there is very good science, and an exensive amount of research, that shows SpA could be added to all the current biologics and would work synergistically with these agents to lead to significantly better results.

I created an independent investigator protocol (IIP) in which I would add SpA to Rituxan, the current blockbuster B cell depleting agent several years ago. This protocol spells it all out and is posted here comboSpAandRituxan.pdf.

I then submitted the data, that took two years of effort to complete to the Eular conference. That abstract can be found here comboSpAandRituxanAbstract.pdf.

UpDate December 2016

I found a poster on the Protalex web site about SpA and its treatment of Immune mediated Thrombocytopenia (ITP) posted Dec. 7, 2016. This will be the first report of the use of SpA in the treatment of human ITP.

As stated in this poster, there are no good treatments for ITP. It is a life threatening disease, and I have personally seen it lead to the death of young people, in front of my eyes. And here is the post. PRTX100 and The Treatment of ITp

My first take is we need new treatments for this disease. And my first impression was that SpA treatment in one of six patients had a great response. But the dose given in these merely six patients is only 1 ug/kg or 3 ug/kg. This is an incrediby small dose. My experience has been that good things really start happening at 12 ug/kg. One patient in this very small trial, meaning "six patients", was reported to have "allergic vasculitis". And there were some more minor infusion reactions.

I'm suprised they had any infusion problems at all. They're may be something unique about these patients with ITP that makes infusion reactions more risky. In a trial at my clinic, the Coeur d'Alene Arthritis Clinic, there were over 100 infusions given to eleven patients in the trial with no significant infusion problems.

Apparently, this ITP group does not consider the side effects significant enough to halt the trial, and higher dose cohorts will now be treated. The one patient really did have an amazing response.

Craig Wiesenhutter, M.D.

I have no disclosures.