In short
Another group of participants with Parkinson's was dosed in July. Dr. Jack Jacobs presented the research at FreedomFest 2024 in Las Vegas, and planning continued for brain blood-flow scans before and after dosing at Washington University in St. Louis.
The July update was shorter than usual. Another group of people with Parkinson's was dosed that month. Other members of the team gave presentations at a conference in Las Vegas, where the update said more than 100 people attended Dr. Jack Jacobs's talk. Two participants with Parkinson's came to the conference to describe their own experience.
The update shared three sets of comments. One came from the parents of a young woman with autism, one from a participant with Parkinson's after a visit to a neurologist, and one from a participant with progressive supranuclear palsy, writing about falls.
The brain's blood supply
Dr. Jacobs used his section to explain why the team focuses on blood vessels. He wrote that the brain makes up about 2% of body weight but receives 20% to 25% of the body's blood supply. Two sets of arteries, the carotid and the vertebral arteries, feed a vast network of smaller vessels. These deliver glucose and other nutrients to billions of nerve cells and carry away their waste.
The team believes the underlying problem in vascular disease of the brain is endothelial cell dysfunction, meaning the cells that line the blood vessels become unhealthy and leaky. Dr. Jacobs wrote that this can lead to stroke and to neurodegenerative conditions, including Alzheimer's and Parkinson's. Blocked or burst small vessels can cause mini strokes, which over time can add up to a form of dementia.
Stroke and animal research
He gave background on stroke, the fifth leading cause of death in the United States, with about 800,000 strokes each year. About 85% are ischemic strokes, caused by a blocked or narrowed artery. The rest are hemorrhagic strokes, caused by a burst vessel.
Dr. Jacobs then described earlier animal research. In animal models of stroke, FGF-1 given quickly reduced the area of damaged brain tissue. He wrote that the reason is not entirely clear, but may be that FGF-1 keeps stressed nerve cells from dying. He added that, unlike most proteins, FGF-1 has been shown to cross the blood-brain barrier, the lining that keeps most substances in the blood out of the brain.
He also noted that PET scans, which track how the brain uses glucose, are widely used to follow Parkinson's and Alzheimer's.
His last example was a published mouse study of multiple sclerosis. An image showed a blood vessel with a damaged lining that appeared well ordered again after 30 days of FGF-1. The authors of that study suggested vessel-lining damage may be the first step in multiple sclerosis. Dr. Jacobs wrote that this one picture had been a strong motivation for the team.
CEO Dan Montano closed by noting that each month participants with Parkinson's, stroke and dementia report changes in speech, walking, thinking and memory. He wrote that he hoped to move FGF-1 through the FDA process as quickly as possible. The rest of the update covered company matters and other topics.
This summary covers the Parkinson's research in the July 2024 update. The complete update, including the other topics it covered, is below.
Read the complete July 2024 update as published
The text of the update Zhittya sent, word for word. Pictures, charts and layout are in the PDF. Open the PDF.
July 23, 2024, Monthly Update
Introduction
This July 2024 Update will be shorter than normal since we have all been very, very busy with a lot going on. In July, we treated another cohort of Parkinson’s Disease patients in the British Virgin Islands. Vika and Sergiy were there to support Ann and Sam Cross, and Dr. Harlan Vanterpool, while Dr. Jacobs, Daniel Jr., and I, were at the FreedomFest 2024 in Las Vegas giving presentations and speaking with interested parties.
FreedomFest 2024
We were at the FreedomFest from July 10 – 13 and had an outstanding response to our message. Here is a photo of me making my presentation on the main stage.
Here is a picture of Dr. Jacobs’s presentation, where the room was full, over 100 attended.
At the FreedomFest, we added new friends and visited with our existing friends. It was nice to have people be so positive and supportive. These are people who have watched us for the last five years as we have advanced our medicines and generated the data we will need for our FDA approvals.
Moreover, many suitable investors expressed their interest in the Pre-IPO Placement we are working upon. Bart Vossen was there to facilitate their interest and guide them through the investment process. If you are interested in Zhittya’s last Pre-IPO funding round, please contact Bart Vossen at: bhvossen.rmena@gmail.com.
Republican National Convention in Milwaukee: July 14 – 18.
I was fortunate enough to be able to attend the Republican National Convention this July in Milwaukee. It was my 6th Republican National Convention which I started attending in 1976 with Governor Reagan and returned in 1980, 1984, 1988, and 1992. I was blessed to find many of my friends from those days still active in government now. I met and talked with several US Senators, Congressional representatives and former Cabinet members. I introduced them to our amazing medicine and what we have accomplished in the heart, the brain, and more. I told them that we hope to be back at the FDA early next year and I would like to keep them posted on our progress or delays, as I believe our medicine can treat the cause of death responsible for 65% of all adult deaths. I was very blessed that several asked for my business card, as many of them had a friend or family member that may want our treatment. Many old contacts were renewed, and new ones were made. I found that every gathering I went to, when people asked what we were doing, and I told them, they often called over some of their friends suffering from heart disease, brain disorders, or diabetes to hear what FGF-1 can do for them.
We have outstanding medical data on treating heart disease, brain diseases and type-2 diabetes in humans and yet to get our medicine to the millions of people who need our drug, we need FDA approval. I believe besides great medical data (which we have) to get approval from the FDA we need (1) you (our readers) to demand that the FDA perform in a timely manner to the truth of what our medicine can do, and (2) that those with political power support our efforts. It was nice to hear from so many people attending the Convention that our medicines are needed and needed now!
Vika Montano’s Patients’ Comments Section: Every month, I receive emails and phone calls from our test subjects. I select a few so you can read what those who have joined our Medical Research Studies are reporting to us.
Patient #1 is a 26-year-old female patient suffering from autism. She is an amazing young adult, and her parents are wonderful, wonderful people! Here is a message from her parents:
As you know, Jacqueline was the second patient with autism to be dosed with FGF-1 in October of 2023. In addition, she also has seizures, but her concerns for me were even more profound.
At the age of twenty-six years old, she communicates with the use of a letterboard, demonstrating she is of normal intelligence, but you wouldn't know it from looking at her. She's just under five feet tall, underweight, and for the majority of her life, hasn't enjoyed eating.
Prior to going to the British Virgin Islands for treatment, I felt my daughter was on a glide-path towards an early death, based on her lack of interest in eating. (That's why I pestered you so much to get her into a trial!)
A few weeks after the treatment, she wrote that her vision had improved, and I noticed a significant improvement in her ability to coordinate her right and left side. For several months after that, I didn't see much improvement.
However, in early June, something changed dramatically with her. She started becoming an enthusiastic eater, loving chicken, beef, rice, salmon, Indian and Italian food, often devouring a meal that would satisfy a two-hundred-pound man. Her weight and general health have been steadily improving, and my wife and I are thrilled to continue the treatment. I no longer see her as being on a glide-path to an early death, and am genuinely excited for her future, perhaps for the first time in her life.
The quality of her communication with her letterboard is also greatly improving, as demonstrated by this recent lesson on the difference between a monarchy and a democracy. In answer to the question of which form of government she preferred, she wrote: I AM PARTIAL TO A DEMOCRACY AND I AM GOING TO TELL YOU WHY. SENSING THAT DEMOCRATIC GOVERNING MAKES THE MOST SENSE BECAUSE IT GIVES POWER TO THE PEOPLE.
Thank you, Dan, Vika, Jack, and all of Zhittya Genesis Medicine for your efforts to give “power to the people” and help millions live healthier and more fulfilling lives.
Patient #2:
Hello, my friends, I wanted to share a surprising update with you.
I saw my neurologist in person today for the first time since October 2022, shortly after returning from the BVI. I fully expected her to say I’ve declined noticeably, but she said I’m the same on some tests and better on some (including walking).
Clearly, some days are better than others, but I will take this as a sign that the FGF1 has started to take effect.
Thanks, XXXXXX
Patient #3 a person with PSP (Progressive supranuclear palsy, a disorder where falling down many times a day is very common).
Ms. Montano, I think that the FGF-1 treatment is starting to work? Anyway, I only had a minor fall yesterday and I only have had one semi-major fall today, but of course I am still a long way from where I need to be, but at least I am showing some improvement?? J Wasson Cross Border Medical Tourism Cross Border Medical Tourism services is for those people who want to be considered for Zhittya’s future clinical trials or its current Medical Research Studies. Cross Border’s focus is to fill all available slots in the Medical Research Studies in the British Virgin Islands and The Bahamas, while we wait for other clinics to come online.
Cross Border is working on filling the available slots for the next BVI Medical Research Studies (intranasal FGF-1 for Parkinson’s disease) on the following dates:
Cohort #27: August 19 – 24, 2024
Cohort #28: September 5 – 10, 2024
Cohort #29: October 22 – 27, 2024
Cohort #30: November 12 –17, 2024
I am showing cohorts further out in time since we are filling up faster and have fewer spots open each month.
Please contact Sam Cross at Cross Border Medical if you wish to be considered for the BVI cohorts or slots in The Bahamas. Sam’s email address is: sam.crossbordermedical@gmail.com.
In addition, if you are interested in participating in the brain scan studies which will take place at Washington University in St. Louis, please let Sam know. There are a finite number of slots for the imaging studies. These studies will look at brain blood flow, before and after treatment with FGF-1. There has been no reported pain associated with the MRI scan.
Upcoming events:
Nothing to do with our medicine.
July 31, 2024: Luncheon with General David Petraeus with the World Affairs Council.
I have personally purchased some tables at this event to hear this wonderful American share his views of the world. If you are in Las Vegas and would like to join us, please email me, dan333@aol.com for a seat at this event as my guest.
Dr. Jack Jacobs
As many of you readers may know, we believe the underlying cause of vascular disease in the brain is a result of a process known as endothelial cell dysfunction occurring in the brain’s blood vessels. Sick and leaky endothelial cells lining brain blood vessels can lead to stroke, and neurodegenerative diseases, including Alzheimer’s disease, and Parkinson’s disease.
That is why healthy people such as Vika, Dan Montano, and I, have taken the intranasal FGF-1 medication to heal any possible endothelial cell dysfunction we may have in our brains before it progresses to something more serious. Let’s take a closer look at the brain’s blood supply and the issue of vascular dysfunction.
Although the brain is only about 2% of the total body weight in humans, it receives 20–25% of the body's blood supply. Because brain cells will die if the supply of blood which carries oxygen is stopped, the brain is the body’s top priority for blood perfusion. Even if other organs need blood, the body first attempts to supply the brain with a constant flow of blood. Two major groups of arteries supply the brain with blood, including the carotid arteries and the vertebral arteries, as shown in the figure below.
These major arteries break down into a vast array of smaller arteries, arterioles and capillaries in the brain supplying glucose and other necessary nutrients to the billions of neurons comprising the brain and removing waste products that these neurons generate as part of their intense metabolic functioning. Blockage or rupture of these smaller vessels can lead to mini strokes (TIA, Transient Ischemic Attack), which over time can give rise to a condition known as multi-infarct dementia. In addition, recent evidence has pointed to vascular dysfunction in the smaller vessels of the brain as the very earliest step in the progression of events that ultimately leads to Alzheimer’s disease.
Stroke is the 5th leading cause of death in the US, with one person dying every 4 minutes as a result. Approximately 800,000 people have a stroke each year, about one every 40 seconds. Only heart disease, cancer, chronic lower respiratory diseases, and accidents are more deadly. In the US, approximately 40% of stroke deaths are in males, with 60% in females. According to the American Heart Association (AHA), compared to white people, black people have nearly twice the risk of a first-ever stroke and a much higher death rate from stroke. Strokes are a direct result of a disruption in the brain’s vascular system: either the blood supply is blocked or a blood vessel within the brain ruptures, causing brain tissue to die.
Ischemic stroke is the most common form of stroke, accounting for around 85% of strokes. This type of stroke is caused by blockages or narrowing of the arteries that provide blood to the brain, resulting in ischemia from severely reduced blood flow. These blockages are often caused by blood clots, which can form either in the arteries connecting to the brain, or in other blood vessels before being swept through the bloodstream and into narrower arteries within the brain. A depiction of the two most common forms of stroke is shown in the figure below: ischemic stroke caused by blockages in major arteries perfusing the brain and hemorrhagic stroke, which results from a rupture of an artery in the brain.
Blood vessels can burst or spill blood in the middle of the brain or near the surface of the brain, sending blood into the space between the brain and the skull. The ruptures can be caused by conditions such as hypertension, trauma, and aneurysms (weaknesses in blood vessel walls). Intracerebral hemorrhage is the most common type of hemorrhagic stroke and occurs when brain tissue is flooded with blood after an artery in the brain bursts. Subarachnoid hemorrhage is the second type of hemorrhagic stroke and is less common. In this type of stroke, bleeding occurs in the subarachnoid space — the area between the brain and the thin tissues that cover it.
Previous work in animal neuroprotection models of stroke has demonstrated that the rapid intervention by delivery of FGF-1 can diminish the extent of damage in the penumbra area by protecting the jeopardized cells from cellular death. The mechanism by which this transient intervention works in animal models is not entirely clear, but the efficacy of FGF-1 could be related to the prevention of apoptosis (programmed cellular death) of stressed neurons. It should also be noted, that unlike most proteins, FGF-1 has been shown to cross the blood-brain barrier and may be one reason FGF-1 has shown efficacy in stroke models when delivered intravenously.
The figure below shows the effect of FGF-1 treatment in a focal animal model of acute stroke. The stroke infarct area appears as a white area in the slices below, and the effect of FGF-1 in reducing infarct volume is readily apparent.
Metabolic brain imaging utilizing PET scans that monitor glucose utilization has also been extensively used to diagnose and follow the progression of Parkinson’s disease and Alzheimer’s disease. As shown in the figure below, a significant decline in neuronal glucose utilization (red areas in the figure) can be appreciated in patients with only mild cognitive impairment and becomes more dramatic in patients with Alzheimer’s disease.
Finally, the figure below shows a blood vessel taken from a mouse with experimental multiple sclerosis, where the blood vessel is ravaged with endothelial cell dysfunction and the endothelial cell layer has become damaged and deformed. The authors of this medical research paper speculate that this endothelial cell dysfunction may be the initiating event in the onset of multiple sclerosis and lead to the progression of the disease process.
As the animal is treated with FGF-1 over a 30-day period, a remarkable “healing” of the endothelial cell layer is evident.
It can be seen at day 30 that the inside of the blood vessel is now filled with a well-ordered and healthy array of endothelial cells. More than anything, it is this one picture which motivated Dan, Vika, and I to take the FGF-1 treatment. If we have 50 million of these micro-holes in our brain (leading to microscopic leakage of blood into the brain) and FGF-1 can bring that number down to 25 million, this will represent a major medical breakthrough which could benefit many millions of patients in the future. As the FGF-1 can be safely and effectively delivered to the brain via intranasal dosing, it makes perfectly good sense to use this growth factor to heal endothelial cell dysfunction in healthy individuals before the cell dysfunction has a chance to advance to more debilitating disorders, including stroke, Alzheimer’s disease, and Parkinson’s disease.
Conclusion by Dan Montano
I turned 76 years old in July and like most of you, I reflect on so many memories, all the good, the bad and the ugly. I still work 6.5 days a week, about 14 hours a day, because I love to work, and I love what we are doing. As mentioned above, at the FreedomFest we attended this month, the father of a young autistic female we treated came to our booth to tell us of her amazing improvement. We had two of our Parkinson’s disease patients at the FreedomFest to tell their stories of their recovery. In addition, several members of Zhittya’s professional team were at the meeting. As the father finished telling us about his daughter’s amazing improvement, there were no dry eyes in our booth. We all had joy in our hearts from her improvements. Not just her improvement, but maybe we have something that could help the estimated 30 million people worldwide suffering with autism. Every month we are told by people with Parkinson’s Disease, strokes, dementia, and now even autism that we have treated who are improving their speech, their walking, their thinking, their biological functions, their memories and more and more.
We started this journey in 1998, about 26 years ago. We have expended more than $170 million USD advancing these medical treatments. Every barrier, every wall we encountered, we have overcome, and not because we are smart or have amazing luck, but because we work and work and work and never give up. I have had a wonderful life, and I made a lot of money. I spent a lot of that money on toys when I was a younger man that I did not need. Riches and wealth are very strange things. When you have never had them, they seem very important. Once you have had them, their value and importance diminish and things like love, joy, family, and friends become much more valuable.
When I talk to a US Senator about Parkinson’s disease, and he has a family member suffering, I am excited we might be able to help that family member.
When the father of the autistic girl tells me of her improvements, I cry with real joy that maybe her life will now be better, and maybe we can improve others’ people’s lives who suffer with autism. I have met many people suffering from Parkinson’s disease, heart disease, strokes, dementia or autism who were treated with our drug and whose lives were extended and their health condition improved and that is true wealth. It is often said about money, that you cannot take it with you when you pass. I believe that saving lives, lessening the pain and suffering of others, is knowledge that you surely can take with you!
I thank you all for being on this journey with us, and I pray we can get this medicine through the FDA as quickly as possible. I am certain in my soul that we will succeed and give many, many people better lives.
Bless you all!
Dan Montano, CEO
Zhittya Genesis Medicine
1120 North Town Center Drive, Suite #270,
Las Vegas, Nevada 89144
United States of America zgm.care
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