Clinical trial to test combination of two drugs in treating fibromyalgia

Sep 6 2012

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."