Clinical trial to test combination of two drugs in treating fibromyalgia

Published on September 6, 2012 at 7:18 AM · 8 Comments

A chronic pain condition and numerous gastrointestinal disorders may all be caused by a virus.

That's a Tuscaloosa-based surgeon's theory likely headed for a clinical trial early next year and one drawing support from a University of Alabama researcher who studies how viruses replicate.

The theory of Dr. William "Skip" Pridgen, the physician, is now at the core of a start-up company, Innovative Med Concepts, which has already raised most of the capital needed to fund the Phase II clinical trial to test a novel pain-treatment therapy.

Pridgen is the company's president and managing partner. Dr. Carol Duffy, a UA assistant professor of biological sciences, serves as the company's chief scientific adviser.

The clinical trial will test the effectiveness of a combination of two drugs in treating fibromyalgia, the chronic pain condition known both as a diagnostic and therapeutic dilemma. The trial, pending FDA approval, will involve 140 fibromyalgia patients at 10 sites around the country. The researchers hope it will begin by February 2013.

Results from lab work performed by Duffy could further support trial results and also lead to a potential diagnostic tool for physicians treating patients who exhibit fibromyalgia symptoms.

"We are now in the final stages of accumulating investors," Pridgen said.

The undisclosed medicines have previously been shown to be effective in treating the virus, herpes simplex type 1, at the center of Pridgen's theory. This is the virus that causes cold sores. He earlier filed a provisional patent on the repurposing of both of these drugs for the treatment of fibromyalgia and various gastrointestinal disorders, as they had not previously been known as treatment options for those conditions.

The company is assisted by an experienced team of consultants and UA's Office for Technology Transfer.

Pridgen, who has treated more than 3,000 patients with chronic gastrointestinal issues and, more recently, chronic pain, said his theory began developing after seeing periodic recurrences of many of his patients' discomforts.

Pridgen theorized it might be a virus, so he prescribed an anti-viral drug for their treatment. His patients responded positively. Because some of them also voiced other complaints, he also prescribed a second medicine, which also happened to possess anti-viral properties.

Upon those patients' return, they indicated that not only were their GI problems much better, but other problems, including chronic fatigue, fibromyalgia, depression and anxiety were improving, and that their energy levels were rising.

In an observational study of some of Pridgen's patients, he found the medicine combination had an efficacy rate of almost 90 percent.

The two medicines to be tested within the clinical trial work in different ways to counter viruses, Duffy said.

"The first drug inhibits the virus from replicating at one stage of the virus life cycle, while the other drug inhibits it at another stage and, in addition to that, it also inhibits the virus from reactivating. So, you are basically hitting this virus in three different ways."

The UA professor's role in the effort comes in two waves. First, she is seeking to confirm the virus' presence in the affected patients. The second aspect involves the potential development of a quantitative test to determine whether a person has fibromyalgia. Presently, such diagnoses are based on patients' subjective responses to physicians' questions about their pain.

In potentially developing such a test, Duffy is focusing on signaling molecules in the body called cytokines. The body produces different levels and types of cytokines based on what it encounters, Duffy said.

Duffy will obtain blood samples from the clinical trial participants and measure cytokine levels. Participants will periodically rate their pain levels during the course of the trial, and Duffy will study whether there is a correlation between the patients' reported pain levels and the cytokine levels.

If a correlation is shown, Duffy would then check cytokine levels in healthy people to gauge the typical difference in cytokine levels between pain-free people and people experiencing pain. This could lead to potentially pinpointing a cytokine level where fibromyalgia treatment would be warranted.

Chronic pain and fibromyalgia are just two of a number of other chronic conditions that may be made better by this combination therapy, the researchers said. Fibromyalgia is the most severe condition, so it was selected as the first condition to be studied.

If the clinical trial and tissue study prove Pridgen's theory correct, Innovative Med Concepts would then potentially approach pharmaceutical companies to gauge their interest in buying the patent and making the drugs available for fibromyalgia and a number of other conditions.

For someone whose career thus far has been devoted to basic research, Duffy said this new venture has required a shift in her mindset, and she said she finds it rewarding to potentially more directly help the public through her research.

Pridgen concurred.

"We may have found a rather big piece of the puzzle that no one has been able to figure out," Pridgen said. "It's an exciting time for me, Carol and The University of Alabama."

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Comments
  1. Gloria Winscott Gloria Winscott United States says:

    I've had ME/CFS for 18 years.  I'd like to get off of the pain meds and stop the IBS.  I've tried every natural product there is, but nothing works.  I wish you success.  I know so many people who suffer from ME or fibro and now it looks as though my son has conracted it.

  2. lynn666 lynn666 United States says:

    This sounds great to a long time sufferer like me and makes alot of sense.  I can't wait for the results, I just wish I could be part of this study.   Good luck

  3. paul bell paul bell United Kingdom says:

    this liiks promising to me as i believe fibro is psrtly linked to a gut complaine, My understanding is candida and poss other is taking over good bacteria in the gut, this robs us of nutrients and causes leaky gut , as the bug passes its own toxins into the body and this toxin causes aches pains , brain fog depression, irritable bowel. i have started to cut out carbs and sugar and this robs the bug of its essential nutrients. a high prorein diet in the absence of csrbs suststains the body better and prevent the hunger.i have lost a huge pert off my belly through less bloating and ibs has settled down less headaches and more energy, and also less pain. i use a probiotic to encourage good stomache flora.

  4. Geraldine Barton Geraldine Barton United Kingdom says:

    So whats happened about this XMRV ??? Dr Judy told me I most likely got it when I was bitten by a mosquito when I was visiting family in Montreal,Canada.Now I have to live  with it.

  5. Bill Cohen Bill Cohen United States says:

    Is it really useful to announce a "theory" in fibromyalgia issued by a small academic institution's publicity office?    There are thousands of theories related to fibromyalgia issued worldwide.  I thought it would be the purpose of a dedicated online patient newsmagazine to vet through published peer-review research related to actual evidence pertaining to treatment.  If you simplyl re-distribute press releases, I'm sorry--I just don't get it.

  6. Norma Boyd Norma Boyd United Kingdom says:

    Hoping in my heart this works. No one understands how living with Fibromyalgia is. Most upsetting is when not only people don't believe, but doctor also. In my doctors practise only one of the Doctors that I know of believes. The others look at me like its my fault because I'm overweight. I have lost some weight and I still feel the same.
    Looking forward for the outcome and thanking all those Doctors who believe.

  7. Denise Mills Denise Mills United Kingdom says:

    There is still a lot of ignorance within the medical profession here in the UK re-fibromyalgia which is quite frustrating when you have suffered with this chronic illness for 15 + years like the effect it has on your general well being and social life. It would be great to have some hope that some drugs have been found to be effective to help with this chronic condition, any help to make living with this and to get through day to day living would be great. I to would be willing to take part in this trial if it ever gets as far as being trialled in the Uk or becomes available here in the UK on prescription. Here's hoping that the trial has a positive out come.

  8. Debbie Fields Debbie Fields United States says:

    I have Fibro/Chronic fatigue and have had it for years now...each year it seems the pain gets worse...I began to have symptoms after aquiring Mono (EBvirus) I truely believe this syndrom is caused by a virus and the right conbination of virial medications could wipe this out...Imagine the thousands of people that could get off of Government assistance and have a normal life...I for one am tired of the bandaide, I want a cure!

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
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