05.18.2016

IMC-1 antiviral combo may be next blockbuster fibromyalgia drug

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This story on Dr. William “Skip” Pridgen’s IMC-1 fibromyalgia drug combination was first published on NationalPainReport.com and is being reprinted here with permission from the editor. 

The U.S. Food and Drug Administration has fast tracked Dr. Skip Pridgen’s novel pairing of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, for a phase III trial in 2017. Based on data from a prior phase II trial, the combo known as IMC-1 could give some stiff competition to Lyrica and Cymbalta, two of the most profitable drugs prescribed for fibromyalgia.

Is IMC-1 the next big thing?

A general surgeon with a small practice in Tuscaloosa, Alabama, Dr. William “Skip” Pridgen admits he’s an unlikely creator for the next blockbuster fibromyalgia drug.

But the U.S. Food and Drug Administration (FDA) has fast tracked Pridgen’s novel pairing of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, for a phase III trial next year. Based on data from a 2014 phase II trial, the combo known as IMC-1 could give some stiff competition to Lyrica and Cymbalta, two of the most profitable drugs prescribed for fibromyalgia.

Like so many discoveries, Pridgen’s was accidental. He’d been treating patients with chronic gastrointestinal conditions for years and started to notice a pattern: Their symptoms would wax and wane over time, increasing whenever patients would become overly stressed. Pridgen’s mother is a virologist, and the pair speculated the stressors could be activating a virus, which in turn aggravated gastrointestinal and other symptoms. He’s concluded the HSV1 virus, commonly associated with cold sores, may be a culprit in fibromyalgia.

“Many herpes viruses are known to significantly upregulate COX enzymes in the body, which in turn are important for efficient viral replication,” he explained in a media release. “In theory, physical or emotional stress in patients can reactivate the virus and result in perpetuation of the symptoms of fibromyalgia. Effectively suppressing latent viruses may significantly improve the pain and related symptoms of fibromyalgia.”

But almost everyone on the planet has been exposed to the HSV1 virus. So, why do some people develop fibromyalgia while others do not?

“There’s a group of people who are genetically damaged in a way,” Pridgen explained. “There’s something that’s wrong with the immune system such that most people can force the virus to go into dormancy. These patients can’t.”

Pridgen thinks the virus remains active in the gastrointestinal tract and possibly in the sinuses and pelvic region as well.

The body thinks there’s an ongoing war 24/7; everything gets amplified,” he said.

(This story gives a more technical synopsis of Pridgen’s theory about the connection between HSV1 and fibromyalgia.)

Years ago, Pridgen began testing his HSV1 theory by offering antiviral medications to fibromyalgia patients whose symptoms alternated over time, and they reported some minor improvements in functioning. These same patients often complained about their chronic pain, and he began giving samples of Celebrex, an anti-inflammatory commonly prescribed for arthritis, to see if it might help.

He noticed those who received the combination of an antiviral and Celebrex dramatically improved over time. They not only reported a decrease in their gastrointestinal issues, but they also had less pain, fatigue, headaches and other symptoms commonly associated with fibromyalgia. Pridgen realized he might be onto something, and so did his patients. Word of mouth spread, and more fibromyalgia patients began coming to his practice.

The U.S. Food and Drug Administration has fast tracked Dr. Skip Pridgen’s novel pairing of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, for a phase III trial in 2017. Based on data from a prior phase II trial, the combo known as IMC-1 could give some stiff competition to Lyrica and Cymbalta, two of the most profitable drugs prescribed for fibromyalgia.

Dr. William “Skip” Pridgen

“It really was just the planets aligning for me,” he says. “I knew each drug alone didn’t do a whole lot, but when given together, they did something remarkable.”

In 2014, Pridgen’s biotech company, Innovative Med Concepts, released data from its phase II trial involving 143 fibromyalgia patients treated at 12 U.S. clinics. The patients either took IMC-1 or a placebo for 16 weeks.

“We had pain reduction levels that rivaled or were comparable to other fibromyalgia drugs,” Pridgen said. “It wasn’t just that we reduced their pain. In all the measures we looked at [including fatigue, anxiety, headaches, TMJ, etc.], we seem to have an impact overall.

“We’re radically different [from other fibromyalgia drugs],” Pridgen continued. “Instead of just trying to reduce pain perception, we think we’ve discovered what is at the root cause [of fibromyalgia].”

Carol Duffy, associate professor of biological sciences at University of Alabama at Tuscaloosa, began partnering with Pridgen on his research in 2011. She believes IMC-1 works because it’s hitting HSV1 on two fronts: Famciclovir keeps the virus from replicating, and celecoxib stops reactivation and replication.

“When he gives them the meds, those fibro-like symptoms of widespread pain [and] fatigue, seem to go away, but it takes a while. It usually takes two months of being on the meds,” she said. “I think it’s much better than narcotics as far as treating symptoms. I feel like it’s treating it further up the line than narcotics.”

Annie George, a 22-year-old college student from Boston, is one of Pridgen’s success stories. She was diagnosed with fibromyalgia in high school and has tried numerous pharmaceutical treatments over the years. None of them helped, and most caused bad side effects.

When she first started seeing Pridgen in 2014, she was struggling to complete her undergraduate degree in engineering. She’d landed in the hospital several times with unexplained fevers, severe stomach pain and other symptoms. Her fatigue was so debilitating that she’d get up in the morning, take a shower, eat breakfast and then have to take a nap before she could attend classes. After a two-hour class, she’d come home and sleep for 12 hours, only to wake up exhausted again.

“I basically gave up all hope of living a normal life, of wanting to be a doctor, of wanting to be an independent person,” George said.

George and her mother flew to Tuscaloosa to meet with Pridgen after reading about his promising drug combo. She’s been on IMC-1 for about a year now, and it’s changed her life.

“Within two months, I started noticing a very big difference,” she said. “I could go to class and not get a fever. I could be out of the house for eight hours straight, which I hadn’t done since high school. I could do more, and the pain is just a lot less.”

She’s pain free most days, and her fatigue is nearly gone. George is working on her master’s degree and applying to medical school.

“It’s a day and night difference,” she said. “I’m not even the same person. I’m actually a normal 22-year-old girl.”

Like every fibromyalgia treatment, IMC-1 doesn’t work for everyone. Phase II results showed 37.9 percent of patients reported a 50 percent or greater reduction in pain after 16 weeks of treatment. That’s slightly better than Cymbalta, the most effective of the three FDA-approved fibromyalgia drugs.

Side effects were low, with more patients from the placebo group dropping out of the trial due to adverse reactions than those taking IMC-1.

Pridgen expects even better results from next year’s phase III trial because it will use the dosage he’s been perfecting in his practice for the past six years. Phase II used a lower, less effective dose, he said.

Phase III may enroll up to 1,200 patients at around 60 sites, some of which could be international. Several major pharmaceutical companies have already expressed interest in IMC-1, and a new drug could be on the market within three years.

Pridgen thinks the combo might also benefit patients with ME/CFS and irritable bowel syndrome, and trials are tentatively planned for those conditions.

More information about IMC-1 can be found on Innovative Med Concepts’ website.

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Comments

  1. Jane Porter says:

    I approached two different doctors in the past 18 months, sharing that I believe my fibro/cf is linked to a viral thing in my spinal cord. I can feel the pain radiate from there—and I’ve had fibro since I had shingles in 2006. I’ve continued to have shingle pain and problems since, and when I take an antiviral like Valtrex, everything gets better in terms of pain…enough that I can function better. Valtrex does not help with mental clarity and the fibro fog is brutal, especially as I’m a writer and need my words. I have been taking does of Valtrex for fibro pain when I can get a new Rx and it makes a huge difference.

    • Donna Gregory/FedUpwithFatigue.com says:

      Hi Jane, I do hear accounts like yours periodically (i.e. improving w/ antivirals) and suspect Dr. Pridgen’s theory may be correct for some of us with fibro.

  2. Sandy Wing says:

    I wonder if this would work with Meloxicam instead of Celebrex? I recently switched from Celebrex to Meloxicam because Celebrex is a fluoride based drug. Many drugs on the market are fluoride based, and I can’t understand why. It’s a poisonous by product of the fertilizer industry, and many groups are fighting to get fluoride out of the American water supply, so why put it in medication?http://www.slweb.org/ftrcfluorinatedpharm.html

  3. Crystal says:

    So interesting to see this! I had chicken pox more than once as a child even though I had the immunization, and I had bell’s palsy as an adult and get cold sores. I never have fevers but I always feel like my body is fighting something, and wonder if it’s more than just Fibromyalgia. I do have IBS too. I might want to try the trial.

  4. Katherine says:

    I am actually signed up for this study! I cannot wait for it to start, even if I get a placebo, I don’t care! If they find that this works then it means myself, and others like me, will finally have answers and relief!

    • Sharon Snell says:

      How do you sign up? I’ve just begun taking L-Naltrexone, which is to balance my immune system .

      • Sharon Snell says:

        Also, cold sores are a big issue for me. I can’t eat oranges, tomatoes, grapefruit..

  5. Sue Lubchynski says:

    Very interesting study that the Doctor thinks is virus related. Years ago I had Bells Palsy which is also herpes/virus related as I understand. Now after reading this and thinking back on that painful time the facial pain felt very much like the body pain I experience now. Looking forward to more info.

    • Donna Gregory/FedUpwithFatigue.com says:

      Sue, have you been properly tested for Lyme disease? Bell’s palsy is a common Lyme symptom. I was just recently diagnosed with Lyme and have learned that many w/ fibromyalgia have undiagnosed Lyme.

  6. Rebecca Rivas says:

    Oh I can’t wait till this combo is “out”!
    I’m trying LDN now, doesn’t seem to be helping too much. Been on it a little over 2 months. Not much else out there that I haven’t tried. Some I WILL NOT take. Such as Lyrica or Cymbalta. Too many side effects. I’m sensitive to medication.

  7. This is interesting. I’ve been ill most of my life with ailments ranging from cold like symptoms to digestive issues to shingles. My mom has always believed that her fibromyalgia has somehow found it’s way from her to me years before being diagnosed with it. My physician who diagnosed me links it to my military training and the weapons I used, but I believe it’s a little of both.

    It’s great that his “accident” has led to this break through.

  8. Jackie Kendro says:

    I’ve also thought a latent virus could be triggered and cause the pain and fatigue. I had shingles and other than the intense pain at the site of the shingles outbreak I never felt better or had more energy than when I took the antiviral meds for shingles. After completing the antivirals I slowly became worse and worse and had to go to a rheumatologist and got a diagnosis of fibromyalgia and psoriatic arthritis. I’m also very interested in the phase III trial! Thanks so much for this information!!

    • Donna Gregory/FedUpwithFatigue.com says:

      It’s definitely an interesting theory. I’m excited to see how the phase III trials go.

  9. Robin Jordan says:

    Most Fibro patients don’t run fevers. I wonder if she had some form of CFS from Lyme dx. Interested in seeing what trails find. I have had Fibro for 15+ years-have never run a fever from it.

    • Donna Gregory/FedUpwithFatigue.com says:

      I think you’re right … from my understanding, fevers are more common on the ME/CFS end of the spectrum. In any case, it’s exciting that we have another possible treatment on the way.

  10. Melissa silberstein says:

    I’ve wondered if it was a viral or bacterial infection that goes dormant until a physical trauma reactivates it. I thought perhaps it was Strep. But, the herpes family makes a lot of sense. I was tested for the chickenpox titre. My number was 10x the number needed to show you’re positive for the antibodies. The number I have is far higher than one would expect to see in a patient who either had a very bad case of chickenpox or who had received the vaccine. I had neither. Both my brothers had bad case each of chickenpox. I must’ve been exposed but, the GP feels I likely only had a couple of pock marks which were hidden in my scalp and that my symptoms mimicked a regular virus.
    I asked specialists and even the pharmacist who deals with the company which makes the shingles vaccine – no one can think of why my number would be so high no had any of them seen a number like mine.
    So, maybe this doctor is on to something – maybe Fibro is caused by the herpes family of viruses. It’s fascinating. Now if only I could get into a trial and have the quality of my life improve substantially. I can hope. :- )

    • Donna Gregory/FedUpwithFatigue.com says:

      It sounds like it’s going to be a big trial w/ lots of locations, so hopefully there will one near you. I’ll stay on top of the story and let people know when recruiting starts. I know there will be a lot of interest to participate.

      I do think it’s an interesting theory. I didn’t put this in the story, but the researchers have done biopsies of the guts of fibro patients and almost all of them had herpes lesions. When you think about herpes, you think cold sore or genital. You don’t think gastrointestinal. It would explain why so many people w/ fibro have gastrointestinal issues.

      • This could make a lot of sense, I was diagnosed with fibro, celiac disease & had my appendix removed with in months of each other. After a colonoscopy I was told that I have lymphocytic colitis which is only found through this procedure. I am on a strict gluten free diet but I have fibro pain everyday & night! I also have thyroid disease which is an autoimmune disease. I really believe they are all connected in someway. I’m hoping this new med will help, because nothing else works!

      • Rebecca Rivas says:

        Thank you Donna, for being such an advocate and being up on the latest for “us”!

        • Donna Gregory/FedUpwithFatigue.com says:

          Thanks, Rebecca. Comments like yours keep me motivated to keep going. 🙂

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