IMPORTANT UPDATE

Dr. Jon Kaiser has been treating patients with HIV, Cancer, Chronic Fatigue Syndrome and other immune system disorders for the past twenty-five years. After primarily focusing on performing research on HIV/AIDS, Dr. Kaiser is now working on a double-blind, placebo-controlled clinical trial of a new treatment for Chronic Fatigue Syndrome (CFS). This trial is called the Synergy Trial and it is currently enrolling patients (more info at http://thesynergytrial.org). Since Dr. Kaiser is no longer in private practice, he will be posting important updates to his research activities on his website.

March 2014

Dear Friends,

As many of you know, it’s been a couple of years since I last sent out my last E-Newsletter. I hope all of you have been well during the past few years. I’d now like to update you on my recent activities.

A Brief Summary
About four years ago, after twenty years of private practice specializing in caring for people with HIV/AIDS, Chronic Fatigue Syndrome (CFS), cancer, and other immune system disorders, I elected to step back from private practice to focus on my research activities.

While this was a difficult personal decision for me to make, I felt that the greater good could be best served by devoting my time to pursuing research and the development of integrative medical treatments that could eventually become FDA-approved, covered by medical insurance and potentially help millions of people living with serious chronic illness.

My interest in performing clinical research dates back to 1999 when, after seeing many of my HIV(+) patients experience antiviral drug side effects due to mitochondrial toxicity, I endeavored to find a micronutrient formula that would help alleviate these serious side effects. The most severe of these included peripheral neuropathy, liver inflammation, and loss of facial fat.

After testing several different micronutrient formulas in my patients, I identified a compound that appeared to both protect the mitochondria from toxicity AND significantly increase the CD4 count. Measuring the CD4 count is the best way to assess immune system strength in people who are HIV(+).

Thanks to a grant from the pharmaceutical giant, Bristol-Meyers Squibb, I performed a double-blind, placebo-controlled study that confirmed these initial observations. The results of this study were extremely positive and were published in a respected, peer-reviewed journal in August 2006. The title of the journal article was “Micronutrient Supplementation Increases CD4 Count in HIV-infected Individuals on HAART: A Prospective, Double-Blinded, Placebo-Controlled Trial [JAIDS 2006;42(5):523-528].”

 

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Despite identifying an intervention with the potential to simultaneously improve antiviral drug tolerability AND increase immune strength in HIV/AIDS, I was unable to convince Bristol-Myers Squibb to continue funding the development of this treatment as a way to enhance the benefits of antiretroviral therapy (ART).

At this point I had an important choice to make. Should I just keep prescribing this beneficial micronutrient compound to my own HIV/AIDS patients, or should I invest my own time and resources to fund additional research on its ability to help those suffering from HIV/AIDS benefit from a nutrient formula that could enhance drug tolerability and immune system strength. I chose the latter.

K-PAX Pharmaceuticals
In 2005, I decided to help form a company called K-PAX Pharmaceuticals whose purpose was to continue investigating and developing this new treatment. K-PAX’s first milestone was to collaborate with the Ontario HIV Treatment Network (OHTN) and Canadian Trials Network (CTN) to perform another double-blind, placebo-controlled trial of this formula in people with HIV/AIDS. The results of this multi-center Canadian trial are due out later this year.

The second big milestone for K-PAX Pharmaceuticals was achieving insurance coverage by the New York State AIDS Drug Assistance Program (ADAP) so that many HIV/AIDS patients in New York could be prescribed, at no charge, the same immune formula that had been studied in the Journal of AIDS publication.

Despite these successes, with 26 drugs already approved to treat HIV/AIDS, the pharmaceutical companies had become even more risk-averse to gambling on a relatively inexpensive, natural treatment for a disease they felt was being treated perfectly well by currently available medications.

Therefore, beginning in 2010, I began testing the ability of this mitochondrial support nutrient formula to improve the fatigue and decreased concentration symptoms of people with another serious disease, Chronic Fatigue Syndrome (CFS).

Chronic Fatigue Syndrome
Briefly, Chronic Fatigue Syndrome is diagnosed when debilitating fatigue is present for at least six months and there are no other medical conditions that could be its root cause. To be diagnosed with CFS, a patient must also be experiencing at least 4 out of 8 symptoms from a list that includes headaches, frequent sore throats, swollen glands, poor sleep, joint pains, muscle pains, and difficulty concentrating.

In the recent past, a consensus has formed confirming that CFS is truly a physical condition and not primarily due to a psychological disorder, although people who suffer from CFS can also become depressed. At the same time, a growing body of evidence has been accumulating which suggests that mitochondrial dysfunction might be one of the causative factors of this complex condition.

With the hope of finding a treatment for my CFS patients, I began giving them the mitochondrial support nutrients found in K-PAX Immune Support Formula. While some responded positively, there were others who did not experience the intended response. This led me to continue searching for what I termed “the missing ingredient” to help improve the success of this intervention.

After combining it with a variety of different nutrients, hormones and medications, I came upon what I can best describe as “a eureka moment”. While working to help some of my most disabled CFS patients regain at least a modest level of functionality, I began co-administering a low dosage of various stimulant medications at the same time as the mitochondrial support nutrients.

After witnessing extremely rapid improvement in a number of my CFS patients, I realized that when I combined a very small amount of stimulant medication with the mitochondrial support nutrients contained in K-PAX Immune Support Formula, that a synergistic effect occurred. That essentially means that the combination is greater than the sum of its parts. As I gave this combination to more of my CFS patients, many who were stuck at a low level of functioning for many years began to quickly improve. The effect I observed was like nothing else I had previously seen with any single intervention.

Since CFS patients can be highly sensitive to pharmaceuticals, it is very important to prescribe the lowest possible dosage of medication. Since there are a number of stimulant medications currently on the market, I needed to identify the optimal medication and dosage to combine with the nutrients. This was a very key part to solving the puzzle.

The medication I identified as optimal for this purpose was methylphenidate hydrochloride. This is the generic version of Ritalin®. Its beneficial qualities include a short duration of action, favorable safety profile, and relatively low cost. It could also be prescribed in very small amounts. Fortunately, because of the complementary effect provided by the mitochondrial support nutrients, I was able to achieve success utilizing a dosage of the drug that was significantly below what is normally prescribed.

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I have now overseen several dozen people with CFS who have taken this combination therapy and I continue to observe a positive effect. The medication appears to act as a catalyst that helps the cells of the brain, nervous, and immune systems utilize the nutrients more effectively, thereby producing a noticeable improvement in energy, alertness and wellbeing…often within just a few weeks. The nutrients can be looked at as the cellular fuel and the methylphenidate as the spark that “lights them up” and improves their utilization and efficacy.

The Next Phase of Investigation
After witnessing these positive effects in my own patients, I decided to conduct an informal study of this innovative therapy in 15 prospectively recruited CFS patients from the general community. Utilizing a well-validated CFS symptoms questionnaire called the Checklist Individual Strength or “CIS” I was able to demonstrate that there was an average 42% drop in fatigue symptoms during the first 12 weeks on this treatment. Alertness and concentration improved by almost 50% as well. In fact, several patients who had been unable to work for several years were able to return to full-time work within a few months after starting this therapy.

 

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This level of rapid improvement in CFS symptoms has not previously been described. The only intervention these patients were given was the low dose methylphenidate plus the mitochondrial nutrients contained in K-PAX Immune Support Formula. Once again, I believe the low dose stimulant medication acts as a catalyst to improve the utilization and efficacy of the mitochondrial support nutrients. The nutrients may also help to prevent the depletion of neurotransmitters that can occur when a person takes a stimulant medication over a long period of time.

Phase II Drug Development
K-PAX Pharmaceuticals is now performing a Phase II double-blind, placebo-controlled clinical trial of this innovative treatment in Chronic Fatigue Syndrome (CFS) patients. The trial is called the Synergy Trial and it is currently enrolling 120 CFS patients at four research sites throughout the United States. The study sites are located at:

  • Palo Alto (Jose Montoya, MD)
  • Salt Lake City (Lucinda Bateman, MD)
  • NYC (Susan Levine, MD)
  • Fort Lauderdale (Nancy Klimas, MD)

The Synergy Trial seeks to confirm my positive preliminary findings, expand on the observations made in prior research studies, and further explore the safety and efficacy of using low-dose methylphenidate in CFS patients who are also taking a CFS Nutrient Formula.

Detailed information on the how to enroll in this trial can be found at www.thesynergytrial.org or by calling 1-855-318-4673.

Performing this clinical trial has been a labor of love and is a very exciting new chapter in my career. There is no doubt in my mind that, should the results of this study reproduce my prior clinical experience, an FDA-approved treatment for CFS would be just around the corner.

I wish you all continued health and well-being and, as always…

Keep Hope Alive!

Jon D. Kaiser, MD
Medical Director
K-PAX Pharmaceuticals, Inc.

K-PAX Pharmaceuticals, Inc. is an integrative medicine pharmaceutical company currently pioneering medicines to strengthen immune function and support optimal energy metabolism – www.KPAXpharmaceuticals.com

 

 

Important Links

Jon Kaiser's PhotoK-PAX Pharmaceuticals

The Synergy Trial for CFS

Dr. Kaiser's Media Page


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