“We may have found a rather big piece of the puzzle that no one has been able to figure out.” – 10-center phase II clinical trial of anti-herpes drug combo hopes to resolve the question



Fibromyalgia and various gastrointestinal disorders may all be caused by a virus – specifically herpes simplex type 1 – according to University of Alabama virologist Carol Duffy, PhD, and Tuscaloosa-based GI surgeon/chronic pain specialist William Pridgen, MD.

Assisted by UA’s Office for Technology Transfer, the two are partners in Innovative Medicine Concepts, a startup company that’s well on the way to funding a clinical trial of two ‘repurposed’ but undisclosed drugs with anti-herpes properties, as a novel therapy for fibromyalgia pain.

GI Patients’ Relapsing Problems Sparked Experiment

Dr. Pridgen, who has reportedly treated more than 3,000 patients with chronic gastrointestinal issues and, more recently, chronic pain, said his theory about a viral role began developing as he observed the periodic recurrences of problems among many of his patients with gastrointestinal “discomforts.”

Theorizing that the underlying cause might be a virus, he tried prescribing a drug for these patients that had previously been shown to be effective for treating herpes simplex type 1 (HSV1, the virus that causes ‘cold sores’). And in fact he found that patients responded positively.

Then, because some of them also voiced other complaints, he prescribed a second medicine, which also happened to possess anti-viral properties.

The result, Dr. Pridgen notes, is that patients began indicating that:

• Not only were their GI problems much better, • But other problems, including chronic fatigue, fibromyalgia, depression and anxiety were improving, • And their energy levels were rising.

Based on his observational study of these patients, he reports, he found the medicine combination had an efficacy rate of almost 90%.

Drug Combo Hits Herpes Simplex Virus 3 Ways

Herpes viruses persist in the body by becoming latent and hiding from the immune system in nerve cells. They are able to reactivate and travel along the nerve cell’s axon (the fiber that conducts nerve impulses from cell to cell).

The two medicines work in different ways to counter viruses, Dr. Duffy explains.

• “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, the second drug also inhibits the virus from reactivating.

“So, you are basically hitting this virus in three different ways.”

Encouraged by these results, Dr. Pridgen next filed a provisional patent on the repurposing of both of the drugs for the treatment of fibromyalgia and various gastrointestinal disorders. “Repurposing” because they had not previously been known as treatment options for those conditions.

The Planned Phase II Fibromyalgia Trial

The clinical trial Innovative Medicine Concepts has in the works, with FDA approval pending, will test the effectiveness of a combination of the two drugs in treating fibromyalgia. (Though a number of chronic conditions may be made better by this combination therapy, the researchers say they chose fibromyalgia as the first condition to study because it is the most severe.)

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When fully funded, and pending the FDA’s approval, the trial will:

• Recruit 140 fibromyalgia patients • At 10 sites around the country. • With a projected launch date by February 2013.

Dr. Duffy’s part in the study of HSV1’s potential role in fibromyalgia will involve two objectives. The first is to confirm the presence of the HSV1 virus in the affected patients. And if it does appear to play a role, a second objective would be to work on developing 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.

Trial Will Involve Measurement of Signaling Molecules

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

Accordingly, Dr. 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 Dr. 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.

And the lab work that Dr. Duffy does to document the trial findings could also lead to a potential diagnostic tool for physicians treating patients who exhibit fibromyalgia symptoms, the partners suggest.

Pharma Co. Would Be Needed to Produce & Market the Therapy

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

So, speaking of their potential ability to supply a big piece of the fibromyalgia puzzle, “It’s an exciting time for me, Carol and The University of Alabama,” Dr. Pridgen says.

Contacts:

Dr. Carol Duffy, 205/348-0310, cduffy3@as.ua.edu

Dr. William Pridgen, wlpridgen@comcast.net

InnovativeMedConcepts ContactUs@InnovativeMedConcepts.com

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Source: Based on University of Alabama press release, Sep 7, 2012