“We …feel this is a real game changer” Dr. Pridgen
With 90% of the data from their big Fibromyalgia antiviral study in, Dr. William “Skip” Pridgen reported in the Tuscaloosa News that the results were ‘very positive’. Pridgen enthusiastically stated, “We feel we are on the right track and feel this is a real game changer,” and not just for Fibromyalgia.
“It is a tip of the iceberg. What we are discovering will accomplish so much more,” Pridgen reported, which surely means he believes his approach will work, perhaps in a modified manner, in Chronic Fatigue Syndrome, Irritable Bowel Syndrome, and similar disorders.
Pridgen’s antiviral trial began last year. It involves not one but two antivirals, one of which is believed to have a strong anti-inflammatory component. His is the first antiviral trial to occur in FM.
What makes this all the more remarkable is that it’s happening in a disorder that has received virtually no herpesvirus research (just two small studies in the late 1980s), and which involves a virus (herpes simplex virus) that even the Chronic Fatigue Syndrome community has shown little interest in. It’s being led by a surgeon who has studied fibromyalgia part-time and virologist with no experience in FM (but with extensive experience in herpes simplex viruses).
Pridgen’s preliminary success also flies in the face of statements of made by doctors at the IACFS/ME who find evidence of herpesvirus infections and expect antivirals to be useful in maybe 15% of their patients. It also contrasts with the results from the extensive Chronic Fatigue Initiative Pathogen study by Dr. Lipkin.
While few believe antivirals will be effective in most people with ME/CFS (not to mention Fibromyalgia), nobody in the ME/CFS field appears to have tried using a combination of two antivirals, including one with high anti-inflammatory affects. (Pridgen reportedly assayed several combinations of drugs before hitting on what he believed was the right one.) The Blue Ribbon ME/CFS Documentary film group seemed surprised by the numbers of post-Pridgen treatment Fibromyalgia patients eager to tell their story.
The initial supposition — based on a patent review — that Pridgen used valacyclovir (Valtrex) and celecoxib (Celebrex) appears almost certainly to be wrong; we won’t know what drug combination was used until the results are released, which will probably be in a couple of weeks.
It should be noted that Dr. Lerner appears to find high rates of herpesvirus infection in his ME/CFS patients, and a large study reported by German researchers showed increased viral loads of Epstein-Barr virus in a significant percentage of their patients.
The viral field continues to be nothing if not confusing.
Innovative Med Concepts Brings in High Profile Executive
Pridgen and Duffy formed Innovative Med Concepts to bring the prospective drug combination to market. Innovative Med’s hiring of Rick Burch, a form senior Pfizer Vice President, to be the company President, is another encouraging sign that Pridgen is on the right track. Pridgen’s ability to raise several million dollars from private investors to do the Phase II trial, itself something of a miracle in the ME/CFS/FM field, suggests he had strong data to back up his claims.
Two Studies Down, One Big One to Go
Thus far the drug combo has passed two of the three hurdles the FDA needs to approve a drug. Studies indicated the drug combination was safe in animals, and the Phase II trial, which is almost complete and which looked at efficacy in a limited number of FM patients, looks to be successful.
“We got 90 percent of the results back and they are very positive. In the next couple of weeks, we will see all the data.”
Assuming that the Phase II trial is successful, Innovative Med’s next task will be raising much, much more money for a full blown and very large Phase III trial, which will likely take two to three years.
The Tuscaloosa News reported that Pridgen got started in this area while trying to help his FM patients who were dealing with pain from irritable bowel syndrome. After his mother, a biotechnologist, suggested herpesviruses might be involved, Pridgen dug deeper, but it was the suffering he witnessed in women in Honduras with FM (and few options) that really got him going.
Working two jobs at once, surgeon and FM practitioner/researcher, was, he stated, “tough on my family and my office personnel.” But, at least for now, it appears to have paid off.
The devil, of course, is in the details; we’ll know more about what Pridgen and Duffy found probably within the next couple of weeks.
Find out more
- Big Antiviral Trial Could Usher in New Treatment For Fibromyalgia
- Herpes Simplex Virus in Fibromyalgia and Chronic Fatigue Syndrome: The Devil is in the Details
I am always suspicious of stock market manipulation and other conflicts of interests when it comes to drug companies talking up their “promising” research. Cort, the devil is not in the detail. It is the results of the study and if they can be duplicated by others. It is just that simple.
It’s right to be suspicious particularly when talking about a ‘game-changer’ in such difficult to treat disorders as fibromyalgia (and ME/CFS), and when the treatment is so very different than others. I’m feeling good about this, though. I would bet at this point that Pridgen is really onto something.
Time will tell, though. I was referring to the study results when I said the devil is in the details; how many people were improved, what was the extent of the improvement? How were the side effects – lots of questions still to be answered.
I don’t think Innovative Med Concepts is public is it?
I believe that it’s a virus. Every day I have a peak of fatigue or headache in the early to mid afternoon and then start feeling better, as though my body is fighting something. I also know when I’m getting a bug when I sense the CFS symptoms go down, indicating that my immune system is concentrating on the bug and not the thing causing CFS, or is hyperactivated somehow by the bug.
That’s great news, and I hope that FM is related enough to CFS that the drugs will also work on CFS.
If this a breakthrough, maybe they can speed up the availability.
I hope they find something that actually helps with the fibro been suffering for 7 years still haven’t found anything to really ease up my pain so tired of the pain!!!!
«The initial supposition — based on a patent review — that Pridgen used valacyclovir (Valtrex) and celecoxib (Celebrex) appears almost certainly to be wrong.» Cort, what makes you say this? Why is it not Valtrex and COX-2 inhibitors we are talking about here?
It is not likely that we will se any results from Pridgen’s study in a LONG time. If he’s still collecting the data there will be an enormous amount of work that needs to be done with systematizing and analyzing the data, then the hard work of writing a scientific article, and finally the LONG process of back-and-forth communicating with publishers, peer-reviewing, rewriting the article etc before acceptance and publication. In the next couple of weeks Pridgen and colleagues will know the results yes, but the public? No, it can take years to get a study published! This is depressing, I was really hoping for more details from Pridgen’s studies this spring.
Pridgen told me that drug combo was wrong. (He has other patents that are working their way through the system apparently that are not available. He also told me there will be a press release coming out in the next month. They will apparently release the results in the press, start raising money for the next trial and then publish the paper. Or may be they won’t publish the paper. I don’t know if they publish for Phase II trials? In any case rest assured that an announcement is coming.
In the Tuscaloosa News article it says it’s a new drug. Are you sure it’s a combination of already existing drugs? Whatever it is, if it works it’s very good news.
I’m pretty darn sure they got it wrong. We’ve been following the Pridgen study for about six months and there’s never been a hint of a new drug.
Somebody else ought to be trying to reproduce his results, I think. I am suspicious of what seems like an ambitious doc who is a great fundraiser (businessman) who aims to crack the code for treatment of FM in one go. I wonder how solid and long lasting his results are, and how substantial?
feel this is a bogus report. I think their should be others involved in this and many well known researchers involved.
🙂 We shall see. It is an unusual situation – a surgeon pretty much on his own develops a new treatment for FM; that certainly calls for some skepticism :). On Dr. Pridgen’s side though, he is working with an established herpes simplex researcher (who would surely hate to have her reputation called into question) and he now has on his team a former senior vice president for a major drug company on his roster. I’m betting it’s real; the question for me is ‘how real?’? How much progress and what percentage of patients.
I think that we can agree that if it was just 20% that improved really significantly – that would be a real breakthrough – and would surely lead to more research into an area that has hardly received any research at all in FM.
With regards to other FM researchers I wonder who he would get on board? No FM researchers are looking for viruses in FM – there’s nobody in the entire field that has any experience, so Pridgen looked for experience on the other side – the herpes simplex side – and he found somebody.
Celebrex, according to my late, mother in law, helped wonderfully with her pain. She was told of the possible side effects and decided to take it any way. Did she have side effects? Yes, one very major one, a stroke. When she had the stroke she fell and broke her hip. From there she got dementia. She lived about 3 more years this way and we lost her last year. Yes, it helps pain, but is it worth it?
News of “something” that might give us some relief is definitely good news! I don’t care how long it takes to get on the market, this news gives me hope…something I’ve not had during the four decades I’ve had ME/CFS!
I have had Fibro and ME/CFS for 4 decades too! But I am not hopeful. I have seen these breakthroughs before only to have marred studies and outright lunacy.
I think ME/CFS is post viral but I am not convinced it has to be any one virus. I had Mumps (age 7 or 8) and many swimmers ear infections (ages 7 and 8) and then moved to a steel mill polluted area at age 9. By age 13 I was seeing doctors and going through PT for pain. I am now 52. I believe it can be attributed to a combination of environmental factors flipping a person (See youtube videos searching: “Canary in a Coal Mine” documentary) and a series of viruses which do not have to be the same for every person.
Cort you do great work, brilliant. But I strongly feel this another false lead. I would bet my bottom dollar that cfs is an autoimmune and / or brain neuroimmune disorder that may be often triggered by viruses but is not perpetuated by them. I am still quite hopeful that rituximab will yield good results.
I think Rituximab will be beneficial for a subset of patients. Really, I think a variety immune therapies will end up being helpful; Rituximab, cytokine blockers, microglial inhibitors, antivirals and hopefully this one as well 🙂
Oh good, a series of drugs and drug therapies my insurance will never cover. I am disabled on Medicare and cannot get Medicaid/Federal Government aid as I am just above all thresholds.
If Pridgen’s trials are a success and you have fibromyalgia your insurance companies should eventually cover the drugs I would think (?). At some point (?) 🙂
Cort you do great work, brilliant. But I strongly feel this another false lead. I would bet my bottom dollar that cfs is an autoimmune and or brain neuroimmune disorder that may be often triggered by viruses but is not perpetuated by them. I am still quite hopeful that rituximab will yield good results.
There is not much good news with this illness and so, on reading the article about Dr. Pridgen I hastened to the telephone to tell my husband all about it, and had to be stopped from booking my flight to Alabama then and there! Then I read all the other comments which, I suppose are quite valid. However, I have learnt in life that some pretty marvelous things do happen even though the chips are stacked against them. And so, with this firmly in my mind, I will continue to hope.
🙂 I’m glad he held you back. I feel very good about this, and we’ll know more shortly -hopefully a couple of weeks – when the results are released. I’ll be blogging about that on Simmaron Rising.
This is all really interesting! Recently I had shingles and was given Aciclovir. I noticed that my Fibromyalgia symptoms really diminished and thought it was because I was off work and resting a lot more. But having read this, I’m now wondering if the antivirals were helping the Fibro symptoms! Also, I developed Fibro following a very severe virus which lasted for several weeks, so a viral link would not surprise me at all! It would be amazing if a cure was found for all of us fibro sufferers!
I think more people than we generally think developed FM after a really bad cold. The shingles/herpesvirus connection is interesting…:)
Cort, Pridgen is the President of one of hundreds of biotech companies working on new drugs for many different diseases. Duffy is a big time guy having worked on big time drugs like Lipitor from a PR aspect. the company name is Innovative Med Concepts, LLC, and the drug is being called IMC-1 for now. One discouraging thing is he has talked about his next disease target as being IBS. Certainly would be nice to have him working with “open” medicine format but that’s not how these biomed startups work. They try to develop the next biggie and make a fortune- ie.,. Chimerix which recently went public to raise millions.
My understanding is that it is a new drug combination. I did get to talk to Pridgen briefly and he did state that he’s very interested in helping people with ME/CFS. His next target may very well be IBS, I don’t know. Gotta get through FM first of course
My guess is that his protocol, if it works, will probably apply to anybody who has the kind of infection he’s targeting. He is looking in the gut for it.
Of course, if the drug combo works I hope he and the LLC are is very successful 🙂
Hey Cort, was there any talk about this at the IACFS conference? Do you know if any of the big hitters like Dr. Peterson is interested in the findings?
There was no talk about it at the Conference so far as I could tell, but I did hear that Dr. Peterson is definitely interested in how it turns out.
WOW! This IS pivotal. I have always suspected this with CFS/ME, but not FM. This is interesting, however. I have post herpatic neuralgia of the sciatic and pudendal nerves leading to severe vulvodynia and “stiff bladder syndrome” (irritable bladder vs IC). My niece, who is a gyenocologist, put me on acyclovir and my symptoms improved. I stopped taking it because I thought I was doing better. Now I wonder if I should have stayed on it long enough to see if it helped with my other symptoms. Very, very interesting indeed.
I have had FM since about the age of 7. When I was in my 20’s, I began to have a yearly outbreak of tingling and then clear fluid filled itchy pustules on my feet that began in October or November and lasted until April or May. For 44 years, I tried everything that numerous doctors prescribed for my “dermatitis of unknown origin”, including walking throughout one winter in sandals to prove it was not my winter shoes and boots at fault.
In doing research on Herpes viruses when my husband had ocular shingles, I began to suspect that my foot problem was viral. I spoke to my doctor about it and we agreed to do a blood test when next it appeared. Indeed it showed I had a Herpes Simplex infection and she prescribed Valtrex for a week. The infection was gone within two days and I slept better and felt better than I had in the last 20 years! No pain, no IBS, no FMS, lots of energy! It was absolutely wonderful! The effect lasted for about two months. Then, gradually, the FM and IBS began to return.
I had also read about the anti-viral qualities of L-Lysine when taken on an empty stomach, so I now take that in varying amounts daily. Just a minimum 500-1000 mg when I have no symptoms, but increasing it whenever a suspicious skin or mouth sore begins to appear until the symptom goes away. Usually the maximum dose I have had to take is 4000-5000 mg. If an outbreak continues because of extra stress, etc., then I take the course of Valtrex I have on hand and it is cleared up usually within a day. My doctor debated putting me on daily low-dose Valtrex, but for now, using L-Lysine and having the Valtrex on hand has been great! I usually only have to use the Valtrex once a year and sometimes I go two years without using it — just using the L-Lysine daily. Not only does it keep most of my symptoms at bay, I am hardly ever sick with anything! Now if I could find something to really help my osteoarthritis……..!
well I’m in a quandary, a month and a half ago I started valtrex and celebrex.
it seems to have caused my lymph nodes in my neck to hurt, but at this point
not much more.
Maybe I should have waited, but my life for the last 5 years has been very difficult. I’m ready for a positive change, I have no problem with the risk.
I wish the information concerning the protocol had not been so tightly controlled, it is not fair to this community, with incomplete information I made choices, as I’m sure many others made. This is not about your reporting Cort, I respect and deeply appreciate your reporting.
This is just a note about my own personal frustration.
So for me I’ve got to determine what I do next.
Sorry to inadvertently mislead you David. I made an assumption and we all know how those turn out. It’s been a month and I think we’ll certainly know within a month and maybe a couple of weeks. I don’t think the Press Release will be very long off
please there is NO reason to apologize. you offer hope.
Do you get the feeling that we will have to wait for years for a new drug to come out of this or will Dr. Pridgen let us know in a few weeks what two drugs and there strengths are having promising results? My doctor is ready to prescribe what ever this is.
I will only have my son home for one more year before he enters college and would love to feel good for even a few months while he is still at home.
Thank you so much for everything! You are a God send!
Great question Hope!
Here’s what I think. This was a proof of concept trial; it was done to show that the drug combo might work. I think he pretty much has to say, at least for his investors, what the drug combo and what the dose was. My guess is that we’ll get all that information over the next month 🙂
For better or worse we now seem to be in a business world. We were ignored for years due to the money, one way and another (small scale, insurance co avoidance, a muddy definition, etc.) Now it is just possible that a business person could cut through the longstanding fog and come up with a helpful treatment.
Thanks for reporting and replying to us all, Cort, and I very much look forward to your future reports!
Cort a good study just out from Japan on neuroinflammation and cfs….trust me my friend that’s where the answers lie not in the fruitless search for viruses. …25 years and counting and no progress
I agree. I think ME is an autoinflammatory disease (with or without autoimmunity).
For what it’s worth I agree – more auto inflammatory than autoimmunity
How about a link 🙂
I agree Giji. But, I feel the autoimmune system is first the cause and then inflammation a result of. But they go together and one is just as important as the other to address. Approach from that angle and see where it takes you. C):-)
Thanks Matthias for the heads up on that study. He presented it at the conference. Looking forward to reading that one. It looks like really strong findings.
Neuroinflammation is present in widespread brain areas in CFS/ME patients and was associated with the severity of neuropsychologic symptoms. Evaluation of neuroinflammation in CFS/ME patients may be essential for understanding the core pathophysiology and for developing objective diagnostic criteria and effective medical treatments.
I hope this data will be replicated soon! PET scan , EEG and repeated exercise test together can objectify symptoms. Very important for disability benefits.
An important study.The Japanese have been pushing on some good cfs research over years. Kuratsune has been going a while. Let’s hope they push on.Maybe an article Cort? Having lived in Japan I can attest that many academics speak good English.
Hopefully it will not be Celbrex. I find that drug quite difficult to take and also their are side effects to the heart. At 70 and not doing well I pray that we have something soon because I already lost over 31 years to this dreadful disease.
This is quite interesting. I have felt that my symptoms have had to do with something like a virus due to the systemic nature of my symptoms. I started out with pain and stiffness in my upper back, but after caregiving for my mother two years ago, my symptoms spread down to my lower back and my neck is chronically stiff. I have often thought that my symptoms are like an internal version of shingles.
Here’s a question. My husband gets cold sores, which would indicate an active HHV6?? Could there be any relationship to my symptoms and exposure to my husband? Just curious.
As a laymen reporting, my guess is not because we all carry these viruses in us…but then again I’m just a layman 🙂
I have had cfs for 15 years. It started with a bad case of glandular fever (EBV). I progressively got worse every year and I was an absolute wreck after my second baby. I got to the point where I thought I felt I did not have enough energy to live life. I was always sick with a cold, flu, or some virus or another. Out of desperation and determination (I am not a quitter), I begged my doctor to put me on valtrex (generic brand), based on Dr Lerner’s protocol as per listed on his website. Well, it has been a turning point in my life!!! I still have cfs, but I also have a life again. I have been on it for 1 year. Improvements; orthostatic intolerence greatly improved, improved gut, water retention is exceptional, sleep is exceptional and whilst I wake up tired (I do not have the hit by a truck feeling). Strange improvement – I don’t have bandaid rash any more and no more minor allergies. Possible side effects: my lymph nodes in my groin are very sore and I have strange lines on my inner forearm. I was doing exceptionally well but was then hit by another big virus. But, I have not been sick like I used to be. Even my recurring tonsillitis has improved. It has not cured my cfs but I think if I keep taking it I could even improve further. It is important to note that I am on dhea, vitamin d and low dose naltrexone. Valtrex has not fixed post exercise malaise and I think if I did exercise right now, I would be back in bed for months. The only negative with valtrex is that it costs a fortune. I think if your cfs was triggered by something other than EBV, it may not work. My feelings about antivirals are positive and I think the research is going in the right direction.
Congratulations Allie! I hope you continue to improve 🙂
i have side effects from valtrex so hope they find something else.
once we know the medications used can we get these and not wait for the 2 to 3 year trial to be over? possible some doctors are prescribing these already?
i cant wait and want a sure now.
Yes Missy. I am being prescribed what Dr. Pridgen feels is the right combination of drugs according to my doctor. Originally there was some belief that it would be Valtrex but it is not. It is Celebrex 200mg twice a day and Famvir 500mg twice a day taken at the same time. You can either go see Dr. Pridgen or if your doc (like mine) is willing to work with him and it involves reading 90+ pages than your doc can contact Dr. Pridgen and begin prescribing you the meds. I guess if your doctor is really awesome and trusts you he/she can just start prescribing the meds but I would rather your doctor hear it from Dr. Pridgen.
I just started taking this protocol not too many days ago so there is no relief yet although my doc says that some have felt better in as little as 3 days. I expected that Dr. Pridgen was going to release this information about a month ago and I’m not sure why he hasn’t. Things that make you go hmmmm. He is prescribing it to his patients and like I said is willing to work with other doctors so I don’t know what is going on.
I’m just really hoping this works! I need it to work soooo bad! My doctor did mention two other protocols but that this is the one getting the best results according to Dr. Pridgen.
This news is starting to fizzle and I don’t want it to. I’m desperately waiting for Dr. Pridgen to release his phase 2 study finding even though I trust my own doctor. I am just baffled as to why he isn’t releasing this information yet. If anyone can answer this question it would be greatly appreciated!
It would be great to know how you are getting on.
It’s taking very long for study results to be published
and it has become frustrating to say the least.
I realise you may not have time to reply
Considering you’ve just been cured and don’t
want to spend any more time on CFS forums but to
enjoy life now.
I never said I was cured. In fact, I only got to be on the protocol for 8 days. My insurance company called for a prior authorization for the Celebrex so my doctor sent me out the samples that he had left of Celebrex. To my shock because it has never happened before my insurance company denied my prior authorization. My doctor has sent in an urgent appeal for Celebrex that I’m waiting the results of. If they deny the appeal then I will see if my doctor is willing to send a prescription to Canada for Celebrex. If not, I have an appointment with Dr. Pridgen that I was going to cancel since my doctor is willing to work with him. I will keep the appointment if all else fails. I’m giving this protocol a long fair shot! I have nothing to lose!
My nurse has asked me on two occasions how I was feeling while on it (evidently some people feel better in as little as 3 days and some get really sick when starting it). If you get sick you are suppose to get off of the combo for a week and then restart. This has actually given me the to time to start a journal so that I can figure out how I’m feeling now and after taking the medication.
If I feel better by any means I will never neglect this community and you will only hear from me more! I want not just me but as many people as possible to be helped if possible!!!
Hopefully, we will hear more from others. It is distressing that Dr. Pridgen is saying the results are promising but I’ve only seen one review and that person never responded to questions. I’m hoping once I’m back on the protocol for a few weeks and give my review that Dr. Pridgen will have had made more details available to everybody and we hear from ore on the protocol.
Yeah, that was just wishful thinking on my part.
I can’t believe you couldn’t finish the protocol!
That’s not the answer I was expecting at all.
I am guessing you did not notice anything during
the 8 days that you were on it …. ?
Ever since I saw your post on Simmaron, I’ve
been split on whether to purchase the combo
from net and go ahead with the protocol.
May I also ask, is it FM or CFS that you have?
No I didn’t really notice anything during those 8 days. I have been diagnosed with both fibromyalgia and cfs but I like many doctors believe it is one in the same. That’s just my opinion though. I think it would be great if you got on the protocol. Since we haven’t heard much from Dr. Pridgen recently it would be great to get some real reviews! Please keep us posted and I will do the same. How can you be sure you are getting the right drugs from the net? Famvir is easy to get approved by insurance and if you can’t get Celebrex approved and you have a doc who is willing to fax a prescription to Canada for Celebrex than that would work. I just didn’t think there was any other way to get the actual medications.
My appeal was just approved!!! Yay!!! Is anyone else going to do the protocol so we can compare notes? It’s still going to run $98 through insurance after going through all that grief but at least I got it! Yay!!! This will be my most expensive medication. I hope there is a generic coming soon!
Hopefully you can start once again
and take it long enough to start
feeling the effects.
Absolutely agree, CFS/FM are very
slightly differing but essentially the same.
As for the drugs, Celecoxib can be bought as generic from Europe (which is where I’m at). But you are right, in USA there is no generic. Famvir is easy to get also.
Just scared of Celecoxib side effects.
Wouldn’t wanna die now that we are so damn close….
Thanks for prompt replies by the way.
Good luck Hope.
Okay, it’s already mid August of 2019. Anyone have a clue what happened to the studies? Last info I can find is from 2014.
There has been a blood test for Fibromyalgia since 2012 that Big Pharma doesn’t want anyone to know about, but most insurance companies are paying for it, since they know that it will save them money in the long term.
This company that has a current trial going on found a possible genetic marker for Fibromyalgia and have had excellent results so far.
They are working on securing sites or do it remotely in the USA and several other countries for the next phase to determine the exact strain and dosage of the TB vaccine. So they are still trying to get a wide variety of people for the next phase, including younger people and males. They will even come to your home for free to draw the blood!
Go to FMTest.com for more information and get tested! Spread the word, since this will be the closest thing to a cure for Fibromyalgia!