September 2024 update

The text of the update Zhittya sent, word for word. Pictures, charts and layout are in the PDF. Open the PDF.

September 17, 2024, Monthly Update

Epiphany on Parkinson’s Disease.

Epiphany Definition & Meaning | Britannica Dictionary. Epiphany can refer to a Christian festival or a moment of sudden insight.

Since May 2022, when Zhittya Genesis Medicine dosed the first two Parkinson’s disease sufferers in the British Virgin Islands (BVI), we have been 100% focused on two questions: is our medicine safe, and how can we use it to reverse Parkinson’s disease? Now, two years and four months later, I am amazed at our success in reversing Parkinson’s disease. We have seen no serious adverse events, and we have witnessed some impressive improvements in motor scores, mental recovery, physical function improvements and more. As I wrote to you in last month’s Update, I have been very frustrated by the fact that after two years we still have not learned what the best dosing of our medicine is to obtain the desired results of a full recovery from Parkinson’s disease. We started two years ago with dosing level 1, and now we are dosing in Protocol 17, where almost 40 times more FGF-1 is given, spread out over a period of two-years. You can read the test subjects' comments in Vika’s section on patients’ comments. We are making great progress, but we are not where I want us to be. I am happy we are doing good, but frustrated that we are not a complete success: 100% recovery.

My frustration has been boiling inside of me for more than a month - why can’t we do better, go faster, and do more.

In May 2022, Zhittya had recruited 7 volunteers to be in the first dosing group in the British Virgin Islands (BVIs). Zhittya was paying all the costs - the flights, the hotels, everything — it cost them nothing. Only two of the seven who had committed showed up: Dr. Daniel Clark and Becky Parker. The other five did not show up, and the money Zhittya had paid out for them was lost, forever.

Obviously, these five people have not been high on my list to work with since then. They have tried to call me and then email me. Then they try Vika, or Sam Cross or someone else at Zhittya - saying now they are ready to be test subjects and have their Parkinson’s disease treated. I have paid very little attention to them. In August 2024, with my personal disappointment and frustration at our slow progress in reversing Parkinson’s disease to full recovery at a high level, I received emails from two of those first five proposed test subjects. I read those emails this time and their report that over the last two years their health decline from their Parkinson’s disease has been dramatic. They indicated that one is now wheelchair bound, had uncontrollable tremors, had difficulty swallowing and brutal constipation, had loss of memories and more. Copied in this September Update is an email from Becky Parker, one of our original patients, who talks about her improvements over the last two years. Is she 100% recovered? No, but she has not declined in the last two years!

Suddenly, I had an epiphany. I should not just be looking at how close our test subjects are to a full recovery; I should also consider how our medicine has kept our test subjects from declining into a Parkinson’s disease living hell!

We do not follow the people we do not treat. We follow those we treat and attempt to discover how we can safely improve their lives and find the dose that accomplishes that. Over the last 24 months, we have increased the dose of FGF-1 by approximately 40-fold. It has been 100% safe. Can the dose go higher or longer to improve people more? These are all questions we are still studying. What I can say is, from all the evidence to date, our test subjects are much better off than those we did not treat two years ago. Do I have empirical evidence to support that statement? No, because we do not keep track of those who we do not treat.

What I can show you is empirical evidence from the monkey study, where one group of monkeys received FGF-1, and the other group did not receive FGF-1.

Here is the chart:

What was my epiphany? It was the realization that Becky Parker is on that blue line on the right side of the graph above – getting better but not fully recovered yet, and the realization that those that did not get dosed two years ago are on that red line on the graph and are truly suffering more. The chart shows the empirical evidence that those monkeys that received FGF-1 dramatically improved and those that did not get dosed continued their downward spiral. Look at the huge difference between the two groups. It has been difficult for me these two years whenever I talk to Becky or Daniel. I know they are getting better, but they are still suffering from Parkinson’s disease, although their suffering is much milder than it was originally. Read Becky’s comments in Vika’s section below.

My epiphany was the “sudden realization” that keeping people from the traditional catastrophic decline of Parkinson’s disease into a living hell of advanced Parkinson’s disease is still a victory for our medicine and our efforts. I am sorry for those people we have not been able to dose, but today I am content that our efforts have done good for those we did dose.

We are preparing the necessary animal testing for the intranasal delivery of FGF-1 into the brain, so we can file an Investigational New Drug (IND) application with the USA FDA. I hope we can accomplish that in 2025, so we start a Phase I clinical trial in 2026 to treat Parkinson’s disease in the United States. Once approved in the US, people’s medical insurance will pay for our medicine.

My frustration at the slowness of our progress has not gone away. However, my appreciation of what we have learned, the people we have treated, and the progress of halting Parkinson’s disease progression is a victory. Full recovery would be better, but 50% improvement is better than five times worse off. Look at the graph above and see the difference.

Vika Montano’s Patients’ Comments Section: Every month, I receive emails and phone calls from our test subjects. September is a big month for redosing our test subjects. We receive more emails when people are preparing for the next round of FGF-1 dosing. Here I have selected a few of their comments so you can read what those who have joined our Medical Research Studies are reporting to us.

Email #1, from Becky Parker, Patient #2:

Dear Dan and Vika and Team,

Lab rat #2 reporting my progress. There have definitely been improvements since I started the FGF-1 factor even though I have been through some major medical issues not related to Parkinson’s that lasted for about a year. During this time, I lost a lot of ground, but when I was able to use the “juice” again things so started improving again.

I want to list some of the gains that have occurred during this time. I am definitely beginning to feel so much better, the anxiety and depression I was experiencing are greatly reduced. I want to be around people again, I’m enjoying playing board games with my kids and grandkids and just hanging out with friends and family. I’m thinking clearer again, the brain fog is lifting. My voice is stronger.

My sense of smell has gotten a little better. An example of this, my husband and I went for a walk and I could actually smell someone barbecuing. I am also enjoying being able to smell some flowers and perfume, something I haven’t enjoyed for a long time. I have more energy and endurance.

My energy has vastly increased. I can now walk up to around 8,000 steps a day compared to a year ago where I was walking about 3,000 steps a day. Two years ago, I struggled getting out of bed and I had trouble turning over, now I just pop up and get out of bed with greater ease and can turn over better. I can now do 16 sit ups, where before I could barely do one! My husband was dressing me every day and now I am able to get myself ready with very little help. It has taken several years to get into the pool and I am able to do it by myself. My mobility in general is improving. I am not freezing like I was, especially when I try to turn around. A couple of days ago my husband and I were actually dancing together in the family room to John Denver. It was so much fun and made me so happy!

My balance has improved. I am walking considerably faster and I’m not shuffling my feet like I was.

I am experiencing improvements with my bowels. I am not leaking like I had been and the constipation is under control. My trips to the bathroom are not as urgent. The pain in all areas that’s from the PD is improving. I have reduced my pain medication by approximately 50%!

There is a change in the tremor. When I am at complete rest, I can sometimes make the tremor stop for a several seconds or up to a few minutes.

Some days are better than others.

My quality of life is so much better! I am so grateful to your company for giving me hope again.

Email #2 Hello, Things look amazingly good, and I am really happy for all of us.

It was nice talking to you. I promised Dan an update so here's where I am.

I am Monkey 14. Cohort 2. I have had results that are nothing but positive. I left BVI two years ago claiming that I was stronger, and my fog was lifting even as I left.

I thank God every day for the return of my brain. The most critical item I was initially worried about getting back was my physical abilities, walking, not walking and tremoring-stepping my way around, shuffling like an old man. I was not very smart.

As I let time run its course to literally re-build the fabric of my mind and repair my shaky body. It was my mind that returned stronger and with less regression first.

Though I was always a vain man and somewhat narcissistic my concern over my physical ailments, that whole distraction from what mattered seemed to pale in comparison all of a sudden one day. It came to me very sure and without warning about six months into the treatment. I could remember things again. Not just someone's phone number but what color my first Porsche was - Vesuvian. A deep shade of purple lol. Dawn Wells was Mary Ann and Alan Hale was the skipper on Gilligan's Island. I noticed this while watching TV at Chili's one afternoon sipping an Arnold Palmer and not chugging a beer.

Suddenly I had a prescient feeling. That is how my world works. It would help you to understand that I don't really know where I am going or what the plan is for me, but I am being led. It is a feeling that all is right. It is a feeling of now is the time. And it says to me - don't worry I've got your back. I trust that feeling with every fiber in my FGF1 marinated body and, more importantly, all of my soul.

I had such a feeling starting my business in 1985. 31 years and 300 million in revenue and hundreds of satisfied clients. So certain was I that I did it all with only one single down quarter in revenue and always profitable. It was as near too perfect because we were led by that power who leads me and I filled it with gas, trusted my certainty and put the petal to the metal. We created a world of success that had no outside salesman or giant marketing budget. A world without a competitive replacement of our software application. Such a place existed because I knew it was right and I did not question my place in it. These feelings have always been reserved for me to simply become aware of my surroundings.

They are never gradual. It is a whack on the noggin. Awareness follows. I never seemed to have to learn anything new - it was always like remembering. I swear it was my Grandmother, bless her soul. She lifted me above the clouds and thought I was the luckiest little kid alive. She used to say that every time I needed a quarter I would be standing there with a dollar in my hand and who, if it dawned on me that I needed anything, could sell refrigerators to Eskimos.

Parkinson's ruined all that for me. Suddenly, bereft of that powerful force leading me ever since I was a child. Parkinsons had crushed my world. I was not being led;

I didn't remember how to follow.

I actually found Zhittya soon after my diagnosis before I lost my way. Eight years before my treatment. I was certain of it. I never once looked elsewhere. I knew that I had been led here to fix me. I remember calling Dan and telling him that I was a volunteer to him and all he had to do was ask. I wished to be Monkey Number 1. I made it as Monkey #14 AND I SHAVED IT INO MY HEAD IN BVI. I didn't even follow it that close I just called one day 8 years later, and I barely missed with Sam to get in Cohort #1. My Grandmother's influence helped tee it up for me as my mother paid my way because life had turned south for me and luckily for me, she secured my monkey way. My force was trying to awaken me.

As I flew home from BVI I knew I had made a good decision. I kept telling everyone about it and they all though it was rather quick to be "cured", I think it likely was, but my brain is a powerful influencer in my life, and I didn't like taking NO for an answer but Pd had made me a NO show.

All of the things I had secretly hoped for returned and after my second dose of Juice about a year into the game my wish had come true. I could listen and remember. I was out front again, thinking I had it all back. A year ago, I had it all figured out - but I didn't. It is a reality that you need to recover your brain. Then you have to temper its application a lot. Be careful if not cautious in your decisions and seek help when you need it. Its ok, soon enough it is normal again.

I made a lot of mistakes and that is not the fault of FGF1. I was in a hurry and I screwed some stuff up. I finally got on SSDI so I don't work. I need to but am patient now as more time goes by and my calm brain is holding off my get rich quick brain. It will find me when it is time. My quest has begun and I'm certain whoever needs me will find me happily waiting for them.

My perspective is this and I hope I offended no one with the telling of my tale.

The magic exists in Dan and Vika, Jack and Sergiy and Sam and all the rest. They are making a difference and their efforts are golden in my book. I have recovered all my memories. I am calm again. My heart sings with happiness that I am back and cries mournfully for all that I missed, broke and squandered because of PD.

I say this in awe of the reality of the situation - there are days I cannot remember I had PD. 15 years. 5 million pills. I know it was all real but now I like to think it was all a bad dream and I pray for all of you and wish for you to find the surety in your heart and soul about your decision and I have asked the force who leads me to help more like me. God came to me and brought me Zhittya - I pray that whatever you believe in does the same for you.

Good luck and Godspeed.

Kevin

Monkey #14

Email #3) Good Morning Vika, I continue to have excellent results and will keep you apprised of developments as they occur. As I told Mr. Montano in our conversation, my neurologist is going to retire at the end of the year. After the examination he performed at the end of June, he seemed genuinely astonished at the results. He declared I had no further physical symptoms of Parkinson’s except for loss of balance and poor gait. He also said the DBS is causing most of my problems. More on this saga later…

With Best Regards,

Follow-up continuation of another status email of #2

Hi Vika,

Thank you for the update and big “Texas-sized” thank you for all that you do for patients. I’ve started the process of shutting down my DBS. I’m doing it with the supervision of my treating neurologist.

This could be an interesting of the efficacy of FGF-1.

Wish me luck!

Email #4- Dear Vika, I am doing OK. Some days are good, other days are heavy. It goes up and down. I went from 3 pills Levodopa to 2 pills per day. Some days are difficult with such a low dose but I really don’t want to take more than that.

I had my interview with Bonnie and we came to the conclusion that I did'n get worse in the last 12 months, and I took less levodopa. So, I think we can say that definitely I am doing better!

I still have problems in my arms with the cogwheel rigidity and in general stiffness. But some days are really good.

In the past I would panic if I feel not good, but now I know that maybe tomorrow or the day after I will feel better again. So, I accept is as a bad day.

I am looking forward to what the 2nd year will bring us. And I am proud to be part of the Zhittya project.

Best wishes, also to Dan

Email #5- I'm really doing well, and have dropped 2 carbi. Per day. Ann and I just purchased 2 electric bikes, something I never thought I would do about a year ago.

Email #6- I’m excited for the next shipment! I do have some temporary improvements. They come and go. Latest is the infection in my left nostril is gone. The swelling in the bolus has receded. Since 2007, when I had an upper GI, it was very swollen; I couldn’t breathe through it very well. In 2004, I got over a lifetime of green discharge. I did not know that discharge was any other color! Now I have no discharge. Embarrassingly, my finger was always in my nose….before FGF-1, I never had any improvements, all changes were negative. Now, my improvements don’t linger, but they give me hope. I can improve.

…the best is yet to come

Email #7- As far as improvements go, it’s truly very hard to tell. Going into this my hope was to slow or stop the progression. I’m confident it’s likely at least slowed it. I’m still traditional medication (e.g. Levidopa) free at this point which I will count as a win.

I’m not experiencing a cognitive decline either. Finally, my left hand still shakes and may be a slight bit worst but the rest of my left side I feel has improved.

I hope this finds you, Dan and the team doing well. Joan and I just welcomed our third granddaughter into this world on 10 August. Cherish every day!

Warm regards,

X ___________________________________________________________________ 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 #29: October 22 – 27, 2024

Cohort #30: November 12 – 17, 2024

Cohort #31: December 9 – 14, 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.

Heart Disease Clinical Trials and Medical Research Studies:

Zhittya is proud to announce that it is beginning its active recruiting and selection process for patients suffering from late-stage heart disease. FGF-1 was originally used in USA FDA clinical trials to treat severe coronary artery disease. The treatment was shown to be safe and a potentially efficacious treatment for those suffering from coronary heart disease. Watch this ABC Nightly News’ clip on Zhittya’s drug being used for the heart indication: https://www.youtube.com/watch?v=IPtv_0LWK4k Zhittya is now actively recruiting patients to participate in Zhittya’s Medical Research Studies in The Bahamas, as well as future USA FDA clinical trials. If you are interested in participating in these studies, please reach out to Sergiy Montano, our Vice President of Marketing at: sergiy@zhittyamedicine.com and he will assist you from there.

Pre-IPO Private Placement

Bart Vossen is still working with people interested in learning more about the Pre- IPO placement we are conducting. If you are an investor and wish to learn more, please email Bart at: bhvossen.rmena@gmail.com I am hopeful the IPO will occur early in 2025.

Upcoming events:

September 26 – October 8, 2024, in Kuwait City, Kuwait we have meetings.

Presentation by Dr. Jacobs in Kuwait City on October 5th sponsored by the Dar Al Shifa Hospital on the topic of “New Modalities for Treatment of Parkinson’s Disease” Dr. Jacobs will be presenting data on our FGF-1 medicine to treat human test subjects with Parkinson’s disease. The event will be in the auditorium of the hospital and several hundred guests are expected.

I first did business in Kuwait in the late 1970s and have many 40-year-old relationships there. During the visit to Kuwait, we will have meetings with business people, possible patients, and possible investors. If you wish a meeting with us while we are in Kuwait, please email me at: Dan333@aol.com Dr. Jack Jacobs As Dan mentions in his Conclusion section below, over the last 40 years there have been more than 3,000 papers in the medical literature that have utilized FGF-1. Very often a paper will discuss utilizing FGF-1 to treat a specific disease and almost every month we add another possible treatment for patients who have a disease for which there is no viable treatment today. One such paper reported that after knocking out the FGF gene in mice, the animals developed hearing loss and the authors suggested that FGF-1 may be a possible treatment for tinnitus.

We are now testing that theory in a clinical study where patients with tinnitus will receive FGF-1 in an effort to reverse this hearing disorder.

Tinnitus fills the ears with sounds that no one else hears. These sounds include ringing in the ears or clicking, pulsing or humming sounds. It’s a common issue affecting more than 50 million people in the United States. It is most common in people between the ages of 40 and 80.

What is the main cause of tinnitus?

Experts don’t know exactly why some people have ringing in their ears and others don’t. But tinnitus is a common symptom of certain medical conditions, which include: 1. Age-related hearing loss. The brain is used to a certain level of sound stimulation. As a result, the hearing nerve is used to a certain level of activity. When hearing loss occurs, the brain receives less stimulation, but the hearing nerve may still fire at the rate it always has. This can cause individuals to hear sounds that aren’t really there. It is estimated that 1 in 3 adults over age 65 develop ringing in their ears.

1. Noise-induced hearing loss (NIHL). Exposure to loud noises can cause hearing loss and tinnitus. This can happen over time or from a single incident, like an explosion or close-range gunshot.
2. Ear injuries and trauma. These injuries may affect nerves or areas of the brain that help individuals hear. People who get tinnitus after an injury usually only have ringing in one ear.
3. Ear conditions. Earwax blockages or ear infections can cause temporary hearing loss, resulting in ear ringing.
4. Medications. Certain drugs can cause tinnitus, including some antibiotics, antidepressants, cancer drugs, and non-steroidal anti- inflammatory drugs (NSAIDs).

People with tinnitus may experience flare-ups after exposure to certain triggers like stress or sleep deprivation. As one can imagine, this can result in a frustrating cycle. It will be very interesting to see if human FGF-1 can be a potential treatment for this widespread hearing disorder.

Conclusion by Dan Montano

I started this journey of developing FGF-1 in February 1998, when I read that doctors in Germany had used FGF-1 to grow new blood vessels in the human heart, thereby creating a possible treatment for “small vessel heart disease”.

I believe small vessel heart disease is responsible for 85% of all deaths that result from heart disease. This represents over 14 million human lives lost every year from a disease that our medicine can reverse in 90 days. As we have advanced over the last 26 years, we have gathered data that FGF-1 can heal diabetic foot ulcers and grow blood vessels in the legs to treat peripheral artery disease/critical leg ischemia. We have seen that in the brains of humans, FGF-1 can reverse Parkinson’s disease and improve stroke recovery, dementia, Alzheimer’s disease, depression, diabetes, autism, bring back memories and more. Every month we are asked by someone if FGF-1 can do anything for additional diseases in the lungs, kidneys, or the gastrointestinal tract. We are even asked if FGF-1 can treat baldness (which it can!).

Dr. Jacobs takes these questions and searches the over 3,000 papers in the medical literature that have utilized FGF-1 over the last 40 years. Very often he finds a paper that utilized FGF-1 to treat a specific disease. Almost every month, we add another possible treatment for millions of patients who have a disease for which there is no viable treatment today. Amazingly, many diseases of the heart, brain, lungs, intestines and more are often simply due to vascular dysfunction, which is a lack of blood flow reaching the cells. The same small vessel disease we can treat in the heart muscle seems to be occurring throughout the human body as we age.

Here are the diseases we are working on now: “No Option” heart disease, Parkinson’s disease, stroke recovery, dementia, Alzheimer’s disease, autism, type- 2 diabetes, ALS, multiple systems atrophy, lung disease, kidney disease, and gastrointestinal disorders. Not bad for a small company with passion and determination!

We have advanced and survived through the Great Financial Crisis, COVID-19, and more disasters. While we do not appear to be lucky, we are determined and resourceful. I know this medicine is a gift to all mankind, and we just have to get through the gauntlet to get the medicine to the people who need it. The term “gauntlet” refers to a form of punishment or discipline in which a person is forced to run between two lines of people who strike them as they pass.

The FDA, Big Pharma, doctors’ bias, academia indifference, public ridicule, and more are truly a vicious gauntlet which all make for some long months. My father was a hard man, born in 1923, lived through the Great Depression, fought in Asia in World War II, and was as tough as any man I have ever known. Once in high school, I won a red ribbon for a 2nd place finish in the 100 yards dash. I went home to show it to my father. He asked me what was wrong with me? Did you come home to brag that you lost the race? Every day I thank God for him, as he made my brother, and I determined to win. Losing was not an option!

I apologize to all of you for the tone of my frustration in the last Monthly Update (August 2024). I have met people with “no-option” heart disease whose life our medicine has extended. I am working now with people who are improving with Parkinson’s disease, autism, stroke and more, and I should be satisfied. We have done more than all Big Pharma and medical academia combined to enhance these people's lives. We are seeking a cure for their disease and not a lifetime of drugs to camouflage their symptoms. I should be satisfied, but I am not! I know there are millions of people out there who need us to win. Sometimes in life, you are so busy looking for the finish line that you miss the small victories along the way that prove you are making the progress needed. I must remember that this is not a 100-yard dash, but a marathon cross-country race through a gauntlet of opposition. I need to remember that even improving just one life is better than improving none.

I believe our pipeline is full of very great things. While I become impatient for results, I also realize if not us, then who would do this? We are still in the race, and we are going to win! Again, please forgive my frustration that was apparent in the August 2024 Update that went out - sometimes I get weary of the gauntlet.

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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