“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
After years of work it’s time to attempt what we’ve never been able to do before – get Congress to force the NIH to double its funding for ME/CFS. Support the historic bill to increase research funding, add new ME/CFS research centers, require the development of a strategic plan, etc.. It will take less than 5 minutes.