Zhittya Update
December 2022
Free Webinar: “Zhittya's Parkinson's Disease Research Study: 6-Month Patient Follow-Up Report”
IMPORTANT: On December 20, 2022, Dr. Jacobs, Viktoryia Montano, and I, will report on the status of the first Parkinson's disease patients dosed with FGF-1 back in May 2022. Data will be presented at this webinar on the medical outcomes with the patients, including safety, cognitive and motor skill changes seen at the 6-month point in the follow-up timeline.
The Zoom webinar will be held at 4:00 PM Pacific time (GMT -08:00), 7:00 PM Eastern time. If you are interested in viewing the webinar, please register at: https://us02web.zoom.us/webinar/register/WN_zcq5Qmq2T6u05juXUahd_A
Thousands of people are following our progress to treat sufferers of Parkinson's disease with our intranasal formulation of FGF-1. This webinar will provide an update on our journey of discovery with the latest data on how our patients are progressing.
Introduction: This December 2022 Update has a lot of information in it, and I hope it will be of interest to you. We have exciting news on both the medical front and the business front, which we will discuss below.
Multiple Systems Atrophy (MSA)
Multiple systems atrophy (MSA) is a neurodegenerative disease, which is often misdiagnosed as Parkinson’s disease at its onset. MSA is a truly horrible disease which progresses much faster than Parkinson’s disease. According to the MSA Coalition, life expectancy after receiving a diagnosis of MSA is 6–10 years. The rapid progression of the disease and the reality that there is no known treatment makes MSA an ugly and horrific disease, especially as it generally affects people in their mid-50’s.
Zhittya has thought about and investigated MSA for the last five years and believes its FGF-1 could be a possible treatment for this disease. Now with the dedicated help and urging of one individual (Mr. Steven Talbert), Zhittya has decided to open up its treatment for MSA sufferers. In December 2022, Zhittya completed the treatment of the first MSA patient in the British Virgin Islands (as part of Cohort 7). We will continue to enroll MSA patients in 2023 in what we have designated as the “Melanie Talbert MSA Medical Research Study.” Melanie Talbert passed away from MSA, but her loving and dedicated husband, Steven Talbert, has fought tirelessly to convince Zhittya to consider treating this disease, so others may live. We hope to enroll 10 MSA patients into this study over the first 6 months of 2023.
I have been hesitant to conduct an MSA study since, unlike Parkinson’s disease, the progression of MSA is very fast. But Steven’s unrelenting efforts in the memory of his wife convinced me otherwise, and Steven is now helping us to identify suitable MSA patient candidates for our study. Steven was his wife’s caregiver for 11 years, and his love for her and the sacrifices he made for her led me to believe that there is some purpose to all of this.
Zhittya is proceeding with this MSA Medical Research Study for two reasons:
Reason One: We believe our medicine is safe and could enhance the lives of many thousands of people suffering with MSA.
Reason Two: My personal reluctance not to take on MSA patients was partly due to my fears of perhaps tainting our amazing safety and medical outcomes record with our Parkinson’s disease patients. But people are suffering and dying from MSA and if we do not take the chance, then they will all die painful deaths because I decided to play it safe and do nothing. For evil to succeed, all it takes is for good people to do nothing! I thank Steven Talbert for showing us the way forward, and Zhittya has honored his wife’s life by naming this Medical Research Study after her. I pray her sacrifice, her suffering and the amazing amount of love she was surrounded with will help us change the world for MSA sufferers! Please read Dr. Jacobs’ section later on in this Update, where he goes into more detail on our beliefs as to the causes of MSA and why we think FGF-1 is an attractive option to treat this disease.
Zhittya’s Business with our Marketing Companies
In an earlier Monthly Update, we mentioned that Zhittya was renegotiating the terms of the licensing agreement with our five Marketing Partners that are listed below:
WUND Healing Biopharmaceuticals, which owns the rights to sell all of Zhittya products for 60 years in the United States and Canada. This is a territory with 370 million people.
Regenerative Medicine of Europe, which owns the rights to Europe, with a population of 450 million people.
Regenerative Medicine of MENA (Middle East-North Africa), which owns the rights to the Middle East/North Africa with a population of over 600 million people.
Regenerative Medicine of Latin America, which has the rights to an area of over 780 million people.
Regenerative Medicine of Southeast Asia, with a population of 600 million people and also with a medical services area (possible medical tourists) of over 4 billion people (over half of the world’s population).
The negotiations have been completed with each of the marketing companies and the revised agreements are set to be signed December 21, 2022, taking effect on January 1, 2023. The new agreements give the marketing companies not only access to Zhittya’s topical wound healing drugs, but also to all drugs developed for injection or infusion (coronary artery disease, peripheral artery disease, etc.) and drugs that can be delivered intranasally (for all the brain disorders Zhittya is pursuing).
I believe this change will make each marketing company profitable and cash flow positive in 2023. I believe this change will enhance the planned initial public stock offerings (IPOs) of each of the marketing companies and make them financially self-sufficient. I firmly believe that in business: “happiness is positive cash flow!”. I also believe that a business is supposed to generate more cash for its investors/shareholders and not to lose money for them. The first four marketing companies have all completed their pre-IPO placements and I believe are in great financial condition for their IPOs in 2023.
Regenerative Medicine of Southeast Asia (RSEA) is the last marketing company to seek funding, and it will start its pre-IPO placement in January 2023. In the following section, I will introduce RSEA to those of our readers that might be interested in learning about a possible investment in the pre-IPO shares of RSEA.
Regenerative Medicine of Southeast Asia (RSEA)
RSEA is the last of five marketing companies to seek investors, and the company owns the rights to all products developed by Zhittya Genesis Medicine for the next 60 years.
RSEA’s marketing territory encompasses over 600 million people. Some of the nations are wealthy, such as Singapore, and some are very poor, like Myanmar. While I believe this territory offers multi-billion-dollar sales potential once our medicines are approved in those nations, this is not what excites me about RSEA now. What excites me is the potential for a large stream of medical tourism into our clinics in Southeast Asia, from the rest of Asia, including China, India, Japan, Korea, etc.
Medical Tourism and Profit Sharing
Zhittya and all of its marketing companies have in their agreements that revenues are shared 50% to the territory the patients originate from and 50% to the territory where the patients are treated. This was put in place to cover the scenario where a heart patient (this was Zhittya’s first medical indication for FGF-1) from Saudi Arabia decides to travel to London to seek Zhittya’s heart medicine to save his or her life. If that occurred, Regenerative Medicine of Europe would get 50% of the revenues and 50% would go to Regenerative Medicine of MENA. In my mind, a fair deal for both companies.
Zhittya has a clinic operational in the British Virgin Islands, and in 2023 will have clinics operational in the Bahamas, Panama, and Mexico to treat Parkinson’s disease subjects who will travel to these clinics from all over the world, including the United States, Canada, Europe, and the Middle East. When we created a financial model to forecast potential revenues from these clinics, I was very pleasantly surprised that Regenerative Medicine of Latin America (RMLA) could make more money than any of the other marketing companies, since we believe RMLA will be processing many patients from the USA, Canada, Europe Middle East and more in its clinics in Latin America!
Zhittya will not have clinics in the United States/Europe/Saudi Arabia until its medicines have final FDA, European Medicines Agency, and Saudi FDA approvals, which may be 3 to 7 years in the future. During that time, the clinics in the Caribbean, Panama, and Mexico will be highly profitable servicing those medical tourist patients who have diseases which only Zhittya’s medicines can treat, and those patients do not want to wait 7 years to be treated in their home nation.
Now, let me return to Regenerative Medicine of Southeast Asia (RSEA). I have been doing business in Asia since the mid-1970s, and there are few countries in Asia I have not had business dealings with. I believe a clinic in Southeast Asia could be a major processor of patients from Japan (population 120 million), China (population 1.4 billion, Indonesia (population 273 million), the Indian subcontinent (population 1.8 billion), and more.
As shown on the map below, more than half the people of the world (over 4 billion people!) are within the circle and Southeast Asia is in the middle of that circle and close to those population centers.
I am having discussions now with possible clinics in Malaysia, Myanmar, Vietnam, and Brunei (Yes, I have been to Brunei!) Once developed, I believe clinics in Southeast Asia would provide Zhittya’s medicines to millions of desperate people who do not have 10–15 years to wait for the formal approval process of their home nations. Even after a drug is approved for sale in the US by our FDA, it can still take many more additional years before that drug is approved by regulatory bodies in Japan, Korea, China, and India for sale in their countries. For example, if the US FDA approves our medicine for Parkinson’s disease in 2028, then India may not approve this same drug until 2038. It is reported that 7 million people in India currently have Parkinson’s disease. If only the richest 1% of those 7 million patients travel to RSEA to be treated, that would be 70,000 patients treated with Zhittya’s FGF-1 for just Parkinson’s disease alone; making RSEA extremely profitable.
I believe RSEA can conduct its IPO at the end of 2023, after the first four marketing companies have completed their IPOs earlier in 2023. I firmly believe that Regenerative Medicine of Southeast Asia (RSEA) has a very bright future and that it will have great revenue streams treating medical tourists from an area with over 4 billion people.
Regenerative Medicine of South East Asia (RSEA) will start placing pre-IPO shares in January 2023. If you have an interest in learning more, please email me (Dan Montano) at: dan333@aol.com.
I will then arrange to have someone talk to you and provide you the additional information you would need before you could invest.
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Dr. Jacobs’ Section
Parkinson’s Disease Webinar
Jack Jacobs here. I hope you all will have the opportunity to join our Zoom webinar on December 20, 2022, at 4 PM Pacific Time, where we will review our approach to treating Parkinson’s disease with intranasally administered FGF-1. Our first two patients (they affectionately refer to themselves as lab rats #1 and #2) have reached their 6-month follow-up examination, and we continue to be very pleased with the progress they have shown with the complete lack of any adverse side effects to the FGF-1 treatment they received. Join us as we talk about the progress that they and others have made after receiving our FGF-1 treatment. You can see and hear it from the patients themselves as we broadcast parts of their 6-month follow-up examinations.
Multiple Systems Atrophy (MSA)
As Dan mentioned earlier in this Update, I would like now to turn to a new medical disorder that we have begun to treat, multiple systems atrophy. MSA is a rare disorder that affects the functioning of multiple systems in the brain. Some of these areas are involved in the control of movement, balance, and coordination, while other areas regulate blood pressure, breathing, bladder, and bowel function. MSA affects men and women equally. MSA usually begins between the age of 50 and 60. MSA is considered a rare disease and affects around three to four people in every 100,000.
Currently, it is believed that MSA is “sporadic,” meaning that there are no established genetic or environmental factors that cause the disease. A few reports have described families with MSA, but this finding is probably very rare.
One main difference distinguishing MSA from Parkinson’s disease is that in MSA, the brain’s autonomic nervous system is impaired. The autonomic system is essential for controlling blood pressure, body temperature, digestion, urination, and bowel function and a high proportion of MSA sufferers show abnormalities in these functions. Also, unlike Parkinson’s disease, MSA affects the cerebellum, the brain’s balance and coordination center.
Concerning similarities, both Parkinson’s disease and MSA are characterized by aggregated deposits in the brain of a type of protein known as alpha-synuclein. The cause of the clumping of the alpha-synuclein protein in MSA and Parkinson’s disease is unknown. Both conditions also specifically affect cells that produce dopamine, a neurotransmitter that controls motor commands. As a result, many of the same motor dysfunctions occur in the two conditions.
MSA patients with slowness, muscle stiffness or shaking may resemble patients with Parkinson’s disease and are called MSA-P. Patients who have more difficulty with balance and coordination are called MSA-C, denoting more involvement of the cerebellum.
There are currently no treatments to cure, slow down or reverse MSA. However, some medications can improve some of the symptoms of MSA. The Parkinson-like symptoms of slowness, stiffness, and tremor may improve with medications typically used for Parkinson’s disease, such as levodopa. Low blood pressure when moving into a sitting or standing position (orthostatic hypotension) may improve by avoiding triggers like alcohol, dehydration, and high temperatures. Increasing water and salt intake can help maintain blood pressure as well.
Clearly, MSA is an unmet medical need and new therapies that can attack the root cause of this disease are desperately needed. Similar to our research into in Parkinson’s disease, our research into MSA has turned up a growing body of evidence that vascular or blood vessel dysfunction may be an initiating event in the disease and lead to disease progression.
As the name implies, one of the chief characteristics of multiple systems atrophy is brain atrophy or shrinkage, as shown in the image below.
A 20–30% reduction in brain volume is often seen in MSA patients on autopsy. This brain atrophy can be diagnostic for MSA, as this type of global atrophy is not seen in Parkinson’s disease. The picture below shows an MRI of an MSA brain on the left and the imaging of a healthy brain on the right. The reduction or atrophy of the cortical region of the brain is readily apparent in the MSA brain.
Brain mapping studies indicate that this atrophy occurs in many areas of the brain, as shown in the figure below. The areas in red are the most common areas of tissue loss and atrophy in MSA patients.
What initiates and causes this brain atrophy? No one knows the answer to this question for sure, but there have been a number of reports that indicate blood perfusion and blood flow become deficient in the brains of individuals suffering from MSA.
The picture below is from a study using a functional MRI technique that can measure, in real time, blood perfusion in various regions of the brain. It can be seen that there is a large difference in cerebral blood flow between a normal individual, a person with Parkinson’s disease (PD) and a person with MSA. In the MSA patient, decreased blood perfusion is indicated by the brighter than normal areas of green and orange color and the appearance of a blue color, which indicates very low blood perfusion in that area of the brain.
We and other medical researchers believe this lack of blood flow is caused by a defect in the vascular system of the brain, where blood vessels in the brain become dysfunctional and “leaky”. This disorder is referred to as “endothelial cell dysfunction” and we have talked about this problem with blood vessels in past issues of this Update, and in particular, as the underlying cause of multiple sclerosis. We believe this same defect is occurring in patients with MSA.
All the blood vessels in our bodies are lined with a single layer of endothelial cells. These flattened cells form the natural barrier between our circulatory system and outside tissues. The endothelial cells are permeable to small molecules such as oxygen, water, and glucose, which is important, as this is the way the body nourishes all of our living cells. However, larger molecules, such as red and white blood cells, immune cells and proteins cannot freely cross the endothelial cell barrier.
The picture below shows a normal, healthy artery that contains a single layer of endothelial cells along with multiple layers of smooth muscle cells that allow the artery to relax and constrict, thereby regulating the amount of blood that flows into a tissue or organ.
If the endothelial cell layer of a blood vessel becomes damaged, as shown in the figure below, it decreases blood flow to a tissue or an organ and develops a vascular leak.
Leaky arteries or capillaries not only reduce blood perfusion to tissues, but also expose the tissue to potentially harmful substances in the blood (for example, enzymes, immune cells, blood clotting factors) that never should escape the blood vessels.
Medical researchers have now implicated “endothelial cell dysfunction” in a number of medical disorders, including multiple sclerosis (MS), multi-infarct dementia, and more recently, MSA. There is excellent evidence that our very own FGF-1 can heal this endothelial cell dysfunction in an animal model of multiple sclerosis.
The figure below shows the inside of a blood vessel which was located within a multiple sclerosis lesion in the spinal cord of a mouse. The left side of the figure shows a blood vessel ravaged with endothelial cell dysfunction, where the endothelial cell layer has become damaged and deformed. As the animal is treated with FGF-1 over a 30-day period, a remarkable “healing” of the endothelial cell layer is evident at day 30 where the inside of the blood vessel is now filled with a well-ordered and healthy array of endothelial cells.
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.
If a similar process is at work in MSA, it makes all the sense in the world to see if FGF-1 may have a beneficial effect if given to MSA patients, and that is exactly what we have begun as discussed by Dan above with our “Melanie Talbert MSA Medical Research Study.”
Getting FGF-1 into the Cerebellum
As I mentioned above, MSA patients with slowness, muscle stiffness or shaking may resemble patients with Parkinson’s disease and are called MSA-P. Patients who have more difficulty with balance and coordination are called MSA-C, denoting more involvement of the cerebellum.
In Parkinson’s disease we know from animal studies (and now hopefully with our human subjects) that FGF-1 is getting into the “substantia nigra” area of the brain, to trigger new blood vessel growth and regenerate new blood flows to the dopamine producing neurons. Patients with MSA-P have atrophy in the striatum/substantia nigra region of the brain, and thus we are hopeful that FGF-1 may work in MSA-P patients as well as it is doing with our Parkinson’s disease patients.
What about patients with MSA-C that have atrophy in the cerebellum area of the brain? In the January 2022 Update, I reported on results we received from our research collaboration with a Minnesota group of scientists who performed an animal study to compare how much FGF-1 gets into various regions of the brain following intranasal or intravenous administration. To summarize those results again, it was found that almost twice the amount of FGF-1 got into most regions of the brain when comparing intranasal to intravenous dosing of FGF-1.
I want to emphasize one point that was noted earlier but bears repeating. This is shown in the figure below that was reproduced from Dr. Frey’s report to us and where I have added in a solid red line to indicate the concentration of FGF-1 that would be required to fully activate FGF-1 receptors to stimulate angiogenesis and neurogenesis in the various regions of the brain. What is abundantly clear from this study and the graph below is that however FGF-1 is delivered to the brain, whether it be intranasally or intravenously, sufficient quantities of the drug get into the brain to hopefully bring about a therapeutic benefit.
And this is in areas of the brain where neuronal dysfunction is known to occur in various neurodegenerative diseases, including the substantia nigra (Parkinson’s disease), the rostral cortex (where motor neurons become dysfunctional in ALS) and the hippocampus, which is affected in Alzheimer’s disease and other dementias. Also note in this chart that the cerebellum area appears to receive many times more FGF-1 than what we believe is necessary to trigger angiogenesis, neurogenesis, and regeneration in the cerebellum. This is why we are so excited about getting started with our first MSA-C patient in December 2022. Based on the above animal data, we are hopeful that we will see a positive effect with our patient.
Please follow us as we begin this journey of medical discovery in trying to identify new therapies for a very horrible disease.
Cross Border Medical Tourism
Every day, we get inquiries as to when the next Medical Research Studies are going to occur.
First: all Medical Research Studies are now being conducted in the British Virgin Islands. We have clearance in other nations; however, we are still dealing with drug importation and other permissions needed before we can dose people. Other locations are not yet available, only the British Virgin Islands.
Second: The next dates for the Medical Research Studies are:
Cohort #8: January 18-24, 2023
Cohort #9: February 16-22, 2023
Cohort #10: March 18-24, 2023
If you are interested in registering for more information on the Parkinson’s Disease Zhittya Clinical Trials or the Zhittya Medical Research Studies, go to pd-studies.com
As we get more data that the medicine is safe and get more positive outcomes with the Parkinson’s test subjects, we get a stronger response and interest to participate every day, thank you!
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Conclusion – Dan Montano
As 2022 ends, we are thankful for what we have accomplished in 2022. In 2022, Zhittya has dosed over 30 people with FGF-1 who are suffering with Parkinson’s disease. Dosing thirty (30) people to see if we can treat or cure Parkinson’s disease is not a large sample size, but no one else in the world, including Big Pharma, is looking at this amazing FGF-1 molecule and its potential to reverse devastating diseases. We have dosed one progressive supranuclear palsy (PSP) patient to see if FGF-1 can improve their health. One is a small sample size; but again, it is more than all big and medium-sized pharma companies in the world have done. We have dosed one person with multiple systems atrophy (MSA) with our FGF-1 drug, which is a small sample size, however it is more than anyone else has done. Zhittya is not Big Pharma, however what we have accomplished with our FGF-1 medicine is impressive. What we lack in size, we make up for with a passion to succeed!
These are exciting times for us! Seeing in humans that our drug is safe and that it has the real potential to halt the progression of Parkinson’s disease and more is very satisfying to us. We still have a long way to go and much work to do. We must prove that our drug can bring about a sustained and lasting benefit for Parkinson’s disease sufferers and others. We may have to tinker with dosing regimens and perhaps have to consider re-dosing patients after 6 or 12 months or so. In 2022, we discovered a vast amount of information on FGF-1’s effects on Parkinson’s disease and more.
Be sure to tune in and hear the latest on our efforts to treat Parkinson’s disease at our December 20th free webinar. Keep this in mind, many people believe that the initial improvement our Parkinson’s disease patients have demonstrated is from the “placebo effect.” The six-month examination is important. Did they have any adverse events from the medicine over the six months? Did they return to their downward Parkinson’s disease decline? Did they continue to improve? Is the placebo effect still around after six months? I do not think so, but tune in and decide for yourself.
Here again is the link to that December 20th webinar:
https://us02web.zoom.us/webinar/register/WN_zcq5Qmq2T6u05juXUahd_A
Next year, 2023, I believe will be a very critical year for Zhittya and the millions of people suffering with diseases that we potentially can treat. I hope by the end of 2023 we can report to you:
We have dosed over 300 Parkinson’s disease patients and that the medicine continues to demonstrate an excellent safety profile and that people improved, similar to what we have seen to date.
We have advanced to dose a total of 10 people with progressive supranuclear palsy (PSP) and a total of 10 MSA test subjects and can report no adverse events related to the medicine and that their decline was diminished. We hope to demonstrate improvements in their condition, and most importantly, that their “life expectancy” was extended.
That we have dosed our first patients suffering with:
multiple sclerosis
stroke disability
Alzheimer’s disease
amyotrophic lateral sclerosis (ALS)
post-traumatic stress disorder (PTSD)
chronic traumatic encephalopathy (CTE)
That we have been cleared in one or more of our clinics to treat “No- Option” heart patients. Heart disease is the #1 cause of death in the world and our prior clinical data, under US FDA Phase I and Phase II clearance, indicates that we have a breakthrough treatment, which I believe can save millions of lives.
I hope to report to you at the end of 2023 that my prayers have been answered and the animal data from our “Voyin Anti-Cancer Project” met the desired endpoints and that we will be starting to treat terminally ill, “end stage” cancer patients.
Zhittya has enjoyed an amazing 2022. I hope and pray that we will have a better 2023. While these Updates try to engage you and bring you along on our journey of discovery, there are many wonderful things we are working upon that we do not share with you, since it would make these Updates 100 pages long!
Vika and I were in the British Virgin Islands from December 3-12 with Cohort 7. Like each cohort so far (and I pray for all future cohorts as well), we found all the people amazing. Most satisfying was how many told us they read the Monthly Updates and that they share the Updates with friends and loved ones. They also shared with us their personal passion to make their own contributions to discovering how to defeat these monster diseases. We have a lot to learn, and we thank our human volunteers for being our lab rats for helping us in this discovery journey. We should all be thankful to this small band of “brothers and sisters”, who have decided they “will not go gently into the night” but that they will fight, fight, fight against the “dying of the light!” We love our human lab rats, and so should you! Say a prayer for them, since they are going where no one has ever gone before to help you and others!
Zhittya will stay with you, Zhittya will advance and with God’s grace, we will get this right.
God bless all and Happy New Year!
Daniel Montano, CEO
Zhittya Genesis Medicine
1120 North Town Center Drive,
Suite #270
Las Vegas, Nevada, 89144
United States of America