Gulf War Illness - Trial Results Show Benefit


K-PAX Pharmaceuticals (Mill Valley, CA) was awarded a DoD Innovative Treatment Evaluation Award (ITEA) by the CDMRP to conduct a Phase 2 open-label trial of KPAX002 - GWI Nutrient Formula (mitochondrial modulators) paired with low dose methylphenidate hydrochloride (Ritalin®) - to evaluate its potential as a treatment for Veterans with Gulf War Illness (GWI).

KPAX002 is made up of two currently available components: 1) low dose Ritalin 2) K-PAX Immune: a micronutrient supplement that supports mitochondrial function across all bodily systems.

The trial, conducted at the Palo Alto VA Health Care System from 2015-2017, examined 15 veterans with a diagnosis of Gulf War Illness. 

The results of the trial showed that KPAX002 produced a mean 25% reduction in overall GWI symptoms. This result was shown to be statistically significant using multiple analytical methods. There were also significant improvements in other GWI symptoms including fatigue, alertness, pain and sleep.

The full study publication can be downloaded (until 10/11/19) at:



Gulf War Illness – New Clinical Trial Now Enrolling

The Gulf War Synergy Trial is currently enrolling participants for a promising new treatment for Gulf War Illness (GWI). This 20-week clinical trial will study the use of a low dose stimulant medication (Ritalin®) in combination with a potent mitochondrial support nutrient formula designed to improve mitochondrial functioning. Mitochondrial dysfunction has recently drawn attention as a potential cause of Gulf War Illness.

The symptoms of Gulf War Illness (GWI) are extremely similar to those of CFS. In fact, research has shown that individuals with GWI are diagnosed with CFS at an incidence of 40 times greater than the general population. Due to a high level of toxic exposure coupled with the stress of war, veterans returning to U.S. with symptoms of GWI may, in fact, have developed CFS at an accelerated rate.

Since this treatment has already been shown to lessen fatigue symptoms in people with CFS, it is possible it can improve the chronic fatigue and cognitive deficits experienced by veterans with GWI

“The classic presentation for mitochondrial illness involves multiple symptoms spanning many domains, similar to what we see in Gulf War illness,” stated Beatrice Golomb, MD, a professor and researcher at UC San Diego medical school. “These include fatigue, cognitive and other brain-related challenges, muscle problems and exercise intolerance, with neurological and gastrointestinal problems also common.”

Golomb has published a study showing that antioxidant supplementation helped to decrease symptoms of fatigue and cognitive dysfunction in patients with GWI.

The nutrient formula used in the GWI Synergy Trial contains these antioxidants as well as other nutrients known to enhance the mitochondrial functioning and improve the health of the nervous, endocrine, and immune systems.

The GWI Synergy Trial will enroll 30 patients during 2016 at the Palo Alto VA Health Center to evaluate the safety and efficacy of this combination treatment. Male and female participants between the ages of 18 and 64 who meet the Kansas Case Definition for GWI are encouraged to contact the Palo Alto VA site coordinator at (650) 493-5000, ext. 62219 to determine if they are eligible to participate. Participants will receive comprehensive medical exams and compensation.

This trial is being sponsored by K-PAX Pharmaceuticals and the U.S. Department of Defense.


Toxic Exposures to Blame for Illness in Gulf War Veterans

Environmental health scientists at Boston University School of Public Health (BUSPH) and colleagues from a dozen other institutions have confirmed that pesticide and other toxic exposures are responsible for the debilitating symptoms seen in Gulf War Illness (GWI), affecting 250,000 U.S. Gulf War veterans.

The report, published in a special issue of the journal Cortex to coincide with the 25th anniversary of the Persian Gulf War, is a comprehensive review of studies conducted on GWI.

Researchers found that veterans’ neurological problems are directly linked to ingestion of pyridostigmine bromide (PB) (prohphylactic medication intended to protect troops against the effects of nerve gas), along with exposure to the nerve-gas agents, sarin and cyclosarin, and oil well fire emissions.

These toxins cause nervous and immune system damage, including neuroendocrine and immune dysfunction, autonomic nervous system irregularities, and even reduced white and gray matter in veterans' brains.

Veterans suffering with GWI experience acute and chronic fatigue, headaches, joint pain, indigestion, insomnia, muscle pain, dizziness, skin rashes, respiratory disorders, and memory problems. Studies have shown that deployed troops suffer higher rates of stroke, ALS, and brain cancer compared to non-deployed ones.

Researchers encourage that ongoing study into the mechanisms and etiology of the health problems of Gulf War veterans is critical for developing new treatments for GWI and related neurological dysfunction.

One such clinical trial currently underway, The Gulf War Synergy Trial, is targeting mitochondrial dysfunction as a treatment for the symptoms of GWI.

Gulf War Illness shares similar features to mitochondrial illness. Researchers at UC San Diego have noted that impaired mitochondrial function accounts for numerous features of Gulf War Illness.

“The classic presentation for mitochondrial illness involves multiple symptoms spanning many domains, similar to what we see in Gulf War Illness. These classically include fatigue, cognitive and other brain-related challenges, muscle problems and exercise intolerance, with neurological and gastrointestinal problems also common.”


Mitochondrial Damage Found in Gulf War Veterans

At the 2015 APS Conference: Physiological Bionergetics: From Bench to Bedside, Dr. Yang Chen from Rutgers Biomedical and Health Sciences gave a presenentation entitled “Mitochondrial DNA is damaged in military veterans with fatiguing conditions”. The talk focused on the involvement of mitochondria in the medical condition known as Gulf War Illness (GWI)

Gulf War veterans who suffer from chronic fatigue, muscle pain, and cognitive dysfunction, commonly classified as Gulf War Illness, may be suffering from chemical-induced mitochondrial damage.

Previous studies suggest that the symptoms of GWI are due to dysfunction of the mitochondria, the part of the cells that generates energy. Dysfunctional mitochondria can cause fatigue and a variety of other systemic illnesses.

The mitochondrion has its own DNA (mtDNA), separate from the cell's, that encodes the proteins needed to produce the molecules that power the body's processes. In a recent study funded by the Veteran Affairs (VA) Clinical Science Research & Development Service, at the War Related Illness and Injury Study Center, researchers measured the mtDNA amount and degree of mtDNA damage in blood cells from blood samples from veterans with GWI.  The findings showed that Gulf War veterans had more mtDNA content and greater mtDNA damage compared to healthy non-deployed controls, providing for the first time direct evidence that mitochondrial dysfunction may be involved in GWI.

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