Men Needed for Fibromyalgia Vaccine Study

By Pat Anson, PNN Editor

The start of a potentially groundbreaking study of a vaccine to treat fibromyalgia has been delayed because not enough men have volunteered to participate.

Massachusetts General Hospital and EpicGenetics – a Los Angeles-based  biomedical company  – received FDA approval last year to enroll 300 fibromyalgia patients in a placebo controlled Phase 2 study to see if the bacillus Calmette-Guérin (BCG) vaccine can be an effective treatment for fibromyalgia. Volunteers must first test positive for fibromyalgia after taking a diagnostic blood test developed by EpicGenetics.  

Half the volunteers will receive injections of the BCG vaccine every 12 months, while the other half will receive placebo injections. The 3-year study was initially projected to begin January first, but has yet to get underway.

“One of the problems we’re having is that the vast majority of the people who have taken the blood test are women aged 50 and above,” said Bruce Gillis, MD, the CEO and founder of EpicGenetics. “We really need more diversity. So we are pushing hard to find more men and more younger people to test.

“We’re still hoping to start this year. But we’re hoping for more diversity in the patients.”

Fibromyalgia is a poorly understood disorder that causes widespread body pain, fatigue, insomnia, headaches and mood swings. The cause is unknown, there is no cure and the symptoms are difficult to manage. Between 75 and 90 percent of the people who have fibromyalgia are women.

The BCG vaccine has been used for over 80 years to prevent tuberculosis and meningitis in children. Gillis believes the same vaccine can be used in adults to stimulate the immune system and reverse symptoms of fibromyalgia.

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“When BCG has been administered in other chronic illnesses, it has triggered the immune system’s stem cells to change their behavior. And in our case, we believe that should allow for the production of healthier peripheral blood mono-nuclear cells -- the white blood cells that we find to be impacted in fibromyalgia,” Gillis told PNN.

“The expectation is that when the patient receives the BCG there is a stimulus to change stem cells and white blood cell production to produce healthier cells.  And as a consequence, their fibromyalgia should be reversible.”

EpicGenetics’ FM/a blood test for fibromyalgia was first introduced in 2012 and is now covered by Medicare and most insurance companies. The cash cost for patients without insurance is $1,080. If the BCG vaccine proves effective, Gillis says the vaccine will be provided at no cost to patients who test positive for fibromyalgia.

Anyone interested in participating in the study at Massachusetts General Hospital should send an email to fmtest@epicgtx.com.

“We need patients from age 18 to 80 plus. And we need more men. I don’t think I’ll ever get an equivalent number of men as I will women, but I need more than just a handful of men,” says Gillis.

‘Opioid Vaccine’ Could Revolutionize Addiction Treatment

By Pat Anson, Editor

Scientists at The Scripps Research Institute have developed an experimental vaccine that appears to significantly lower the risk of an overdose from prescription opioids and could someday revolutionize opioid addiction treatment. The vaccine also blocks the pain-relieving effects of opioid medication.

“We saw both blunting of the drug’s effects and, remarkably, prevention of drug lethality,” said co-author Kim Janda, PhD, a professor of chemistry at Scripps. “The protection against overdose death was unforeseen but clearly of enormous potential clinical benefit.”

Vaccines typically take advantage of the immune system’s ability to recognize and neutralize foreign invaders such as bacteria.

When injected, the opioid vaccine triggers an immune system response when two widely used painkillers -- hydrocodone and oxycodone -- are detected. Antibodies released by the immune system seek out the opioids and bind to the drugs' molecules, preventing them from reaching the brain.

“The vaccine approach stops the drug before it even gets to the brain,” said study co-author Cody Wenthur, PhD, a research associate at Scripps. “It’s like a preemptive strike.”

In tests on laboratory mice, scientists found that the opioid vaccine blocked the pain relieving effects of oxycodone and hydrocodone, as well as any euphoria. The vaccinated mice also appeared less susceptible to a fatal overdose.

“Our goal was to create a vaccine that mirrored the drug’s natural structure. Clearly this tactic provided a broadly useful opioid deterrent,” said study first author Atsushi Kimishima, a research associate at Scripps.

Currently, opioid addiction treatment relies on other opioids – such as methadone and buprenorphine (Suboxone) – to stifle cravings for opioids. But those drugs can be abused as well.  

Although some of the vaccinated mice succumbed to an opioid overdose, researchers found that that it took much longer for the drug to impart its toxicity. If this effect holds true in humans, the opioid vaccine could extend the window of time for emergency treatment if an overdose occurs.

The next step for researchers is to refine the dose and injection schedule for the opioid vaccine. It may also be possible to make the vaccine more effective. Scripps researchers are already working on vaccines to block the effects of heroin, fentanyl and other synthetic opioids.

The Scripps study has been published in the journal ACS Chemical Biology. The study was supported by the National Institute on Drug Abuse of the National Institutes of Health.

Heroin Vaccine

California-based Opiant Pharmaceuticals is developing a similar vaccine designed to treat heroin addiction. The company recently announced that it has obtained exclusive development and commercialization rights to an experimental heroin vaccine invented by scientists at the Walter Reed Army Institute of Research and the National Institute on Drug Abuse.   

“Aggressively addressing heroin addiction is part of Opiant’s mission,” Roger Crystal, MD, CEO of Opiant said in a news release. “In our view, this vaccine fits our plan to develop innovative treatments for this condition. The vaccine has promising preclinical data.”

Opiant’s first commercial product was Narcan, an emergency nasal spray that rapidly reverses the effects of an opioid overdose.

“Whilst our development of Narcan Nasal Spray to reverse opioid overdose has been a significant effort to address the unfortunate consequences of heroin addiction, we see the vaccine as having potential in addressing the disease itself,” said Crystal.

Experimental RA Vaccine Shows Promise

By Pat Anson, Editor

Australian researchers have developed an experimental vaccine for rheumatoid arthritis (RA)  that could prevent the disease from developing in high-risk patients who have a genetic predisposition for RA.

In a small Phase I clinical study, researchers say the "Rheumavax" vaccine was safe and effective in suppressing the immune system response that triggers RA -- a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing swelling, inflammation and bone erosion. About 1% of adults worldwide suffer from RA.

"Current therapies only treat the symptoms and slow the progression of the disease,” said Professor Ranjeny Thomas of the University of Queensland Diamantina Institute. “We have designed a vaccine-style treatment or ‘immunotherapy’ specifically for individuals carrying high-risk rheumatoid arthritis genes and specific rheumatoid arthritis antibodies, called anti-CCP."

CCP antibodies are present in about 60% to 70% of people with RA and can be detected years before symptoms appear.

The personalized Rheumavax vaccine is made by taking a sample of each patient's blood and extracting an immune system cell called dendritic cells. Those cells are then challenged with a foreign peptide and an immune system modulator to create a vaccine that is then injected back into the patient.

Researchers say Rheumavax "teaches" the patient’s immune system to ignore a naturally occurring peptide that triggers the production of CCP antibodies that cause inflammation. In the study, 18 patients received a single injection of Rheumavax and one month later showed no signs of inflammation or RA disease flares.

“At this stage, the technique would not be ideal for widespread treatment or prevention of rheumatoid arthritis because it’s costly and time-consuming," said Thomas. “However, the promising results of this trial lay the foundations for the development of a more cost-effective, clinically-practical vaccine technology that could deliver similar outcomes for patients." 

"This research is such an exciting advancement for arthritis sufferers.  To know that someday in the future, hopefully the near future, there may be a treatment that actually treats the cause, not just the symptoms of rheumatoid arthritis, makes me very hopeful," said  Jennifer Martin, a rheumatoid arthritis sufferer and columnist for Pain News Network.  

"I often worry that my son could have inherited this awful illness from me and that one day he will begin to show symptoms.  To think that there may be a treatment that is effective very early on, or even before symptoms arise if they are able to detect the gene is very reassuring."

Professor Thomas says if Rheumavax proves successful treating RA, it could also be applied to other autoimmune diseases, such as Type 1 diabetes.  The study is published in the journal Science Translational Medicine

Until the late 1990s, one in three RA patients were permanently disabled within five years of disease onset. Although there are no cures for RA, in recent years there has been significant improvement in treatment, with disease control now possible for many patients who receive biologic drugs.