Research news

May 2024 update

A summary of the Parkinson's research in this month's update from Zhittya Genesis Medicine, with the complete update underneath.

Back to the research page · Open the original update (PDF)

In short

Zhittya marked two years of Parkinson's research studies, with more than 150 people dosed. The update reported the first brain scan measuring blood flow in a study participant with Parkinson's.

The May update led with a first for the Parkinson's research: a brain scan taken before dosing, to be compared with later scans.

The first brain scan

On May 6, 2024, the first participant with Parkinson's had an MRI scan at Washington University in St. Louis to measure blood flow in his brain. The main interest was the area in and around the substantia nigra, which holds the nerve cells that make dopamine. Zhittya's hypothesis is that too little blood reaches this area, leaving those cells short of oxygen and nutrients, so that they work poorly, go dormant or die.

The participant was due to begin FGF-1 dosing on May 17. A second scan was planned at six months and a third at 12 months. CEO Dan Montano wrote that if the later images showed more blood flow to the substantia nigra, that would be evidence to help explain the changes in motor skills participants had reported. Zhittya planned to scan 14 more people, mostly people with Parkinson's.

The update recalled an earlier monkey study, done by researchers outside Zhittya. In it, monkeys with an experimental form of Parkinson's developed new dopamine-producing nerve cells six to eight months after FGF-1 was introduced into their brains.

It also said that most participants with Parkinson's had reported changes beyond movement after taking FGF-1. These included clearer thinking, less brain fog, better balance, a returning sense of smell and taste, and better memory.

Reported headaches

Mr. Montano wrote that dosing began at a very low level and was raised slowly over 24 months to the current Protocol 17. He wrote that about 5% of participants reported mild headaches after dosing, lasting from minutes to a few hours. He was not sure these were related to FGF-1, since many people with Parkinson's have frequent headaches. "We will report everything we know," he wrote.

A first dose by spinal tap

The update described one participant with multiple system atrophy, a different and very aggressive neurological condition. He first received FGF-1 by nasal spray in November 2022. In November 2023 he received it by epidural, but little seemed to reach the fluid around the brain, and no meaningful improvement was seen after six months.

In April 2024 he agreed to receive FGF-1 by spinal tap, directly into the cerebrospinal fluid. Whether it would help him was not yet known, and the team planned to keep monitoring. Mr. Montano wrote that this route might be considered for very advanced neurological conditions.

Two years of dosing

May 2024 marked two years since the first two people with Parkinson's were dosed. Over that time the team improved the delivery device, raised the dose from Level 1 to Level 17, and added repeat dosing at six-month intervals. More than 150 participants had now received FGF-1.

Mr. Montano wrote that participants had reported improvements in motor skills, memory, balance and thinking. He added that the work was still at an early stage. The team did not yet know the best dose or how long dosing should last, and expected the answer to differ from person to person.

Dr. Jack Jacobs wrote about visiting Washington University, where he had studied molecular biology. He recalled that the FGF-1 molecule was first purified more than 40 years ago in the laboratory where he worked.

Two participants' comments were shared, on drooling, brain fog, tremor, sleep and walking. The rest of the update covered other research areas, a conference and government relations.

This summary covers the Parkinson's research in the May 2024 update. The complete update, including the other topics it covered, is below.

Read the complete May 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.

May 15, 2024, Monthly Update

Introduction: Several Important Items I Will be Discussing in Detail:

  1. Our first human brain scan to measure blood perfusion in a Parkinson’s disease patient was completed at Washington University, St. Louis.
  2. We have completed our first spinal tap delivery of FGF-1 to a human patient’s cerebral spinal fluid (CSF).
  3. Zhittya’s Conference in The Bahamas has been a huge success, where Zhittya discussed its potential treatments and applications for: a. Parkinson’s Disease b.

Severe Coronary Heart Disease

  1. We plan to file additional applications in The Bahamas for: a. Critical leg ischemia b. Diabetic foot ulcers
  2. Zhittya is celebrating its 2-year anniversary of treating Parkinson’s disease patients. To date, we have successfully treated over 150 test subjects.
  3. Zhittya is continuing its efforts with the US political and governmental agencies towards obtain approval for our medicines in the USA.

Preface

Many things are rapidly developing for Zhittya and our progress is accelerating.

We are opening new projects to advance our animal studies for future USA FDA filings, we are obtaining amazing human data from our Medical Research Studies for Parkinson’s disease, stroke, diabetes, dementia and more. I am going to focus on the six topics I introduced at the start of this Update to try to keep this Update as concise as possible.

  1. Our First Human Brain Scan to measure blood profusion in a Parkinson's disease patient was completed at Washington University, St. Louis.

On May 6, 2024, our first Parkinson’s disease patient had his brain scanned by an MRI machine at Washington University, St. Louis to measure blood perfusion within his brain. Our primary area of interest was looking at blood flow in the area near and around the substantia nigra. This is the area of the brain which houses the dopamine producing neurons, whose dysfunction is generally believed to be the cause of the movement disorders seen in Parkinson's disease sufferers. It is Zhittya’s hypothesis that insufficient blood flow is occurring in this area of the brain and therefore neurons in those areas are suffering from deprivation of nutrients, oxygen, and cell waste removal. Zhittya believes that this deprivation causes those neurons to perform in a subpar manner and can lead to their hibernation or, in a worse case, cause the neurons to die.

In a primate study, when FGF-1 was introduced into the brains of monkeys given experimental Parkinson’s disease; new dopamine producing neurons developed after 6 to 8 months, generating more of the neurotransmitter, dopamine, thereby reducing the abnormal movement seen in those monkeys.

Our Washington University brain scan subject will now travel to the British Virgin Islands to join Cohort #24 to start dosing with FGF-1 on May 17 to learn if our hypothesis is correct. In 6 months, we plan to have him conduct a second brain scan at Washington University and then once again at 12 months. If those brain images show, as I believe, that there is enhanced perfusion of blood to the substantia nigra area of the brain, then that will give us empirical evidence to explain why our Parkinson’s disease test subjects' motor skills have improved so much. That would be great news for all!

Here is a picture of Al going into the MRI laboratory, good luck Al!

Equally exciting is that most our Parkinson’s disease test subjects have reported to us that after taking FGF-1 they have improved cognitive skills, elimination of brain fog, better balance, return of the sense of smell and taste, enhanced short term memory, and even return of long-term memories. As an additional bonus, if the MRI scan shows increased blood perfusion in the memory areas of the brain that would be empirical evidence that stroke, dementia, Alzheimer’s disease, traumatic brain injury, autism, and other brain perfusion diseases could be remedied by intranasal administration of FGF-1.

Zhittya plans to have an additional 14 patients have their brains scanned at Washington University. We plan to scan mostly patients with Parkinson’s disease, but could also include other patients suffering with dementia, Alzheimer’s disease and others with incurable neurological conditions, such as ALS and multiple systems atrophy (MSA). I believe we could have a huge impact on the practice of neurology if these brain scans show an increase in blood perfusion after treatment with FGF-1.

As an example, let’s consider a 27-year-old American man who went and served his country in combat overseas and returns home with PTSD and is told he has a psychological condition. It is well documented that acoustic shock waves from firing a weapon can rupture the fragile capillaries in the brain. It is also well documented that due to the stress of combat that the brain is awash with adrenaline and cortisol, which inhibits FGF-1 actions in the brain to regenerate those ruptured capillaries, leaving areas of that soldier’s brain starving for blood.

Lack of blood flow in those areas would result in those neurons not functioning properly, and therefore the brain does not perform as it should. Similarly, disorders such as chronic traumatic encephalopathy (CTE), traumatic brain injury and more show ruptured blood vessels in the brain, indicating these disorders result from a physical injury and are not merely a psychological issue. You cannot see that injury with your eyes, but you can see it with an MRI scan. If we can scan a PTSD, CTE, or ALS subject, and then dose them with FGF-1 to see if there is new blood vessel growth, it will help pay my debt to these young people who sacrifice so much for my security. Imagine that 27-year-old soldier who today is depressed and suicidal because he is told he is crazy, then learns he has a wound in his head, and that wound can be treated, and he can heal over the next 12 to 24 months.

First, he gets hope, and then he gets results and an improved life. One less suicide of a good young person is a reward to all of us.

If you are a person who prays, as I do, then pray these scans show the world that most of these brain diseases first need new blood flow for cells to be regenerated.

I truly believe FGF-1 can deliver it!

  1. Completion of our first spinal tap delivery of FGF-1 in a human patient.

Primarily now, we are delivering FGF-1 into the brain using intranasal methods.

We are getting great results, without pain or breaking any skin. We started at a very low dosage of FGF-1 and have, over the last 24 months, slowly crawled up the quantity of dosing until we are now at dosing Protocol #17. The worst adverse events which have been reported are from about 5% of the test subjects, and they have reported mild headaches after dosing, which last for minutes to a few hours. Important to note that many Parkinson’s disease sufferers get frequent headaches, so I am not sure if it is related to FGF-1, however we will report everything we know!

Several neurological diseases are very aggressive and, unfortunately, always fatal.

Two examples of this would be multiple systems atrophy (MSA) and amyotrophic lateral sclerosis (ALS). From the day of diagnosis of these diseases, to the best of my knowledge, no one has ever recovered. Life expectancy is measured in a few years. Zhittya has hypothesized that both diseases are caused by vascular dysfunction, where the blood flow to the autonomic areas of the central nervous system (CNS) is diminished. Zhittya believes that as blood flow is reduced in those critical areas of the CNS (areas which control blood pressure, breathing, heart rate and more), the patient suffers a cascade of events which causes their early and untimely death.

We have a patient diagnosed with MSA who has been doing everything in his power to be the first survivor of MSA. We dosed him in November 2022, with intranasal FGF-1, and he seems not to have declined as much as might have been expected. However, he is still not well. In November 2023, he had an epidural introduction of over 100 trillion FGF-1 molecules. He reported some minor back pain and a headache after the epidermal introduction of FGF-1, but the treatment did not cause any serious adverse events. To everyone's disappointment, it also seemed that very little FGF-1 crossed through the dura into the cerebral spinal fluid (CSF) and therefore the entire brain was not washed with FGF-1 as we had hoped. We saw no material improvement in his condition as of 6 months.

He agreed to try a spinal tap to introduce an estimated 250 trillion FGF-1 molecules directly into his cerebral spinal fluid (CSF). That dosing occurred in April 2024 in the British Virgin Islands, where we are cleared to do this procedure with FGF-1. After four weeks, no material adverse events have been reported. Since FGF-1 has an estimated half-life of 4 hours, we can be very confident that after a week that none of our FGF-1 remains in his body and therefore cannot cause any damage. The question now is will it do any good for the patient?

We saw in the FGF-1 treated monkeys that had experimental Parkinson’s disease that improvement started at two months and continued for 7 months. We will continue to monitor this patient to see if there is improvement in his condition. I believe the world owes this man admiration for his courage to go and try what no one in the world has tried before. He is showing us the pathway, he has already shown us that 250 trillion FGF-1 molecules into the cerebral spinal fluid via a spinal tap appears safe. Maybe this will save his life, or a higher amount will save his life — either way, he is fighting!

We have been contacted by an ALS patient who is willing to try FGF-1, rather than accept a painful death. We have told them to wait a few months, so we can see if the MSA patient has improvements. We now have one human test subject who has had introduced into their cerebral spinal fluid 250 trillion FGF-1 molecules, and it appears to have been safe, so maybe we try 500 trillion molecules of FGF-1 with the ALS patient, to confirm if this dose is safe and can possibly reverse his irreversible disease. This form of FGF-1 delivery we believe could be used for very advanced and lethal cases of neurological diseases.

  1. Bahamas Efforts.

From April 27 – 30, 2024, we attended the HEALinc conference in The Bahamas.

Dr. Jacobs, Vika Montano, Dr. Conville Brown (our Bahamian partner), Sam Cross (President of Cross Border Medical Tourism), and I spoke before the assembly. I believe our message was well received and appreciated.

We had the honor of the Prime Minister, the Deputy Prime Minister, and the Minister of Health of The Bahamas visiting our exhibit. They learned about what we believe our medicine can do for critically ill people and how approval of our Medical Research Studies in The Bahamas could dramatically enhance the economic development in The Bahamas.

Here you can see a picture of Vika holding an iPad showing a video of some of our Parkinson’s disease patients and their improvement. You can see me pointing to the Prime Minister, the Deputy Prime Minister, and our partner Dr. Brown on how this could enhance The Bahamas as a medical tourism destination.

Zhittya currently has these applications and future applications with The Bahamas: a) Parkinson’s Disease: Our application has been reviewed by the Ethics Committee in The Bahamas, and we are waiting for written approval before we start treating Parkinson’s disease patients there. b) Heart Disease: Our application has been reviewed by the Ethics Committee, and they need some basic data which should be submitted within a week. Our hope is then we will be able to start treating severe heart disease patients and extending their lives. c) Critical Leg Ischemia: We learned that in The Bahamas that diabetes is very prevalent, and that critical leg ischemia (CLI) is a material medical issue. As some of you may recall, Dr. Jacobs presented a webinar several years ago to the Arab world (along with doctors from the Saudi German Hospital Group) about our idea of utilizing the FGF-1 drug to treat critical leg ischemia. Zhittya has already written the protocol, and we presently have a lot of FGF-1 drug available, so we will be filing an application to treat CLI in The Bahamas very soon. I hope we are treating that horrible disease within months. Critical leg ischemia is a very bad disease, as it most often leads to an amputation and then a life expectancy for the patient of only 5 years. Zhittya has animal data that when FGF-1 is injected into the legs of animals with CLI, that it stimulates the growth of new blood vessels and therefore reverse the CLI in the animals. The US Government’s National Institute of Health (NIH) estimates two million Americans suffer from CLI, and an estimated 40 million worldwide, a major health issue. d) Diabetic Foot Ulcers (DFUs): We also learned from a vascular surgeon in The Bahamas that diabetic foot ulcers (DFUs) are very common in The Bahamas’ diabetic community. Diabetic foot ulcers are very difficult to heal, as there is insufficient blood flow in the skin to allow the surrounding cells the blood needed to heal that wound. Zhittya has more data on healing diabetic foot ulcers than any medical indications, other than the heart. FGF-1 in human clinical studies has healed 100% of all chronic non-closing DFUs. Non-closing DFUs can lead to infections and amputations, which are expensive and can become fatal. I know since my most wonderful aunt suffered and died from DFUs. Zhittya will have an application on file with The Bahamas authorities very soon, and I hope to be healing and extending more lives by using FGF-1 to heal diabetic foot ulcers. It is estimated that 10 million to 30 million people develop diabetic foot ulcers every year.

  1. We have our first human research subject for the question of “Can FGF-1 repair and improve a normal brain?”

Zhittya has a friend and an investor/shareholder of ours, who is a 77-year-old retired medical doctor. He received his MD from Stanford University Medical School and has been at the cutting edge of medicine his whole life (and developing impressive wealth along the way). He is physically fit and reports he has no known brain disorders. He has seen one of our test subjects, who had suffered from mini-strokes and was mentally compromised, start to recover and improve motion, memory, balance, and thinking. The doctor also knows that Dr. Jacobs, Vika, and I have been taking FGF-1 as a prophylactic to prevent possible future brain issues. Since it has been so safe, he wants to try it and see if it can “supercharge his brain” in his own words.

It should be an interesting experiment to see if FGF-1 can make this man smarter?

He is scheduled to be dosed in Cohort #25 starting on June 10th.

#5) Two-year anniversary of treating the first Parkinson’s disease patients.

In May 2022, Zhittya dosed the first two Parkinson’s disease patients in the British Virgin Islands (BVI). During these last two years we have enhanced the delivery device, increased the dosage from “Level 1” up to “Level 17” and extended the redosing to six months intervals. Regarding safety, we have seen only a few people get minor headaches, but regarding efficacy, we have seen amazing improvement in patients’ motor skills, memory, balance, cognitive and more. We are still at the early stages of our journey of discovery, however I strongly believe we are on the path to reverse Parkinson’s disease, by simply revascularizing the brain utilizing FGF-1’s potent angiogenic properties. We still do not know what is the best dosing level or length for recovery. I am pretty sure it will vary with each patient, depending on how much damage their brain’s vasculature has endured.

I believe we have found that vascular dysfunction in the brain is the cause of many brain disorders and that we can treat them all as we learn more. I believe at the 5-year anniversary reunion party for patients (three years in the future) and at the ten-year anniversary reunion party, there should be many happy and healthy people.

#6) US political and government agencies.

Prior to starting this biotech business, I was an Investment Banker for 30 years financing companies in high-tech, medical tech and more. I had offices across the United States and in London. I have raised billions of dollars in risk capital for many ventures and been Chief Executive Officer of several publicly traded companies. I have met with Presidents, Prime Ministers, Chancellors and more all over the world and succeeded, because I listen and learn.

I wish to introduce to you Mr. John Laub. Mr. John Laub has been a business associate and friend for almost 20 years. He is by education and training a certified public accountant (CPA). John’s grandfather founded Southwest Gas, one of the largest gas utilities in Nevada, Arizona, and California, generating over $5 billion in annual sales, with over 2 million customers and a stock market cap of over $5 billion dollars. John’s father (a wonderful man) was president of Southwest Gas for many decades. The Laub family is an institution in Las Vegas, and they are honorable and outstanding citizens.

John is president of Zhittya’s marketing partner companies and is the person who will be taking the marketing companies public through IPOs (and hopefully get the shares trading publicly on the New York Stock Exchange). I hope this will happen after the presidential election in the United States when some order returns to the stock market.

John founded and is the president of the Nevada Biotechnology Organization, Nevada Bio. He is also currently on the Board of Advisors to the Touro Medical School. He was the Chairman of the Board of Advisors of the UNLV College of Sciences for 10 years. John is also involved with the national Biotech Innovation Organization. John Laub, as President of our marketing companies, attended the Biotechnology Innovation Organization’s (BIO) Washington, D.C.’s legislative fly-in in April. BIO is the largest non-profit biotechnology-focused organization in the country. People from all 50 states flew into Washington, D.C. John is the representative for the state of Nevada (which he has been for the last 15 years).

He has just returned from Washington, D.C. from meeting with congressional members and their staffs and below is a copy of his comments to me about his trip:

Dear Dan: I met with the congresspeople and their legislative offices that represent Nevada. I shared with them about Zhittya’s incredible success that Zhittya’s drugs have had with Parkinson’s disease sufferers. Every office offered to help with the FDA to make sure the FDA knows the importance of Zhittya’s clinical trials. I discussed with them that we would also be developing a letter-writing campaign to have people in the Parkinson’s community write letters and make calls to encourage Congress and the FDA to move expeditiously on the approval of Zhittya’s drugs. The legislative staff said they would help us.

In addition, many of the members of BIO were very interested in Zhittya’s progress because of the positive impact it will have on many that have the diseases that Zhittya is planning to treat.

John

Please keep in mind, we at Zhittya know we have to get USA FDA approval to get these medicines to millions of people who need them. We have been working on that subject for 26 years, we have spent tens of millions of dollars on consultants and lawyers to accomplish that, and we have a plan. Zhittya always has a plan.

Upcoming Events

July 10, 2024 – July 13, 2024: FreedomFest in Las Vegas, Nevada FreedomFest is one of my favorite events taking place in Las Vegas this year. I know from past FreedomFests that we have many followers who read this Monthly Update and who are already shareholders/investors of ours and who attend the FreedomFest.

I will be giving a main stage presentation on the topic of:

Parkinson’s Disease: 150 human research subjects have reversed their disease with FGF-1 treatment. I will be introducing data and videos of some of our test subjects and then extending my talk into our treatment for heart disease, lung disease and other brain disorders and how we are conducting a small study to prove type-2 diabetes in humans can be reversed. I will also present a case on how the US FDA is taking away our rights to life, liberty, and our pursuit of happiness by their bureaucratic process to hinder innovation and therefore deny your ability to obtain treatments to heal yourself and extend your health and life.

Dr. Jacobs will be giving a workshop on:

Heart disease, stroke, Parkinson’s disease, diabetes and more: medical breakthroughs with FGF-1 are happening now! I know many of you have been following us for five years, you have watched our progress and shared in our delays. Many have been true believers from the start but many of you have been our doubters, who say to me, every year, “Dan, show me proof and I will help.”

Dr. Jacobs will show you the proof, and you will be impressed. At the last three FreedomFests, Dr. Jacobs’ presentations have been standing room only, so do not miss this one — it will be the best proof ever that Zhittya’s medicines can extend your health and life!

If you want more information or wish to attend the FreedomFest go to the direct registration link at: https://freedomfest.swoogo.com/vegas2024.

If you want to go to their website for additional information, go to https://www.freedomfest.com.

If you wish to attend, Zhittya has a $50 discount code for attendees: ZHITTYA50 at checkout!

Vika’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.

#1) Hello, Vika. This is Steve XXXXX of cohort 18, Lab Rat #98. Last Friday afternoon I met with Bonnie Lyons and reviewed my Parkinson’s status.

Improvements are my drooling has stopped, napping has stopped, the chronic fog is absent. Fatigue and apathy are still lurking but at a lesser strength. The speed of my hand tremor is estimated to be 50% less and the muscles in my left arm are relaxing to where I can easily ball my fist and relax it. My sleep is 5 to 6 hours a night with REM. I am pleased with these improvements.

Best regards,

Steve

#2) Hi Vika, Thanks for the information. That’s good news.

I’m doing pretty well overall. I’m starting to see improvements which are encouraging.

Recently I saw someone that I haven’t seen in a year. She commented on how I was walking so much better.

I need to increase exercising because I seem to need less Sinemet when I do.

Thanks,

Bill XXXXXXXXX

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 (BVI), 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 #25: June 10 – 15, 2024

Cohort #26: July 10 – 16, 2024

Cohort #27: August 19 – 24, 2024

Cohort #28: September 5 – 10, 2024

I am showing Cohorts further out in time since we are filling up faster and have fewer spots each month. June and July are both already half full.

Please contact Sam Cross at Cross Border Medical if you wish to be considered for the BVI cohorts. 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. No pain in the MRI scan.

Dr. Jack Jacobs

It was very gratifying for me to visit my alma mater, Washington University in St. Louis, last week where I studied for 4 years to receive my degree in molecular biology. The place has grown incredibly, but still retains its high medical and scientific standards. Over 40 years ago, the FGF-1 molecule that we are now using was first purified in the lab where I was working, and it is remarkable that we are now using this human growth factor to reverse Parkinson’s disease!

As Dan mentioned above, we will be submitting applications in The Bahamas to treat patients with FGF-1 who have diabetic foot ulcers (DFUs) or critical leg ischemia (CLI). Critical leg ischemia is a severe form of peripheral artery disease (PAD) associated with pain in the legs and feet at rest and ulcers that do not heal due to poor blood flow in the arteries. Zhittya has prepared White Papers discussing the use of FGF-1 to treat DFUs and CLI and I will provide links to those two White Papers below.

We estimate that over 100,000 people read our monthly Updates. At least half of these names have been added over the last 24 months, so we believe a significant number of people who are now following us are not aware of the work that has been done in the past using FGF-1 to treat several medical indications. Let me summarize and provide links to the White Papers which we consider to be important medical uses for FGF-1.

1) Is Therapeutic Angiogenesis a Potential New Treatment for Critical Leg Ischemia? Critical limb ischemia is considered an “unmet medical need” with no current therapy available, and therapeutic angiogenesis with FGF-1 has the potential to address the fundamental underlying disorder in CLI by stimulating new blood vessel growth in the ischemic leg. Preclinical studies in animal models of PAD/CLI have demonstrated that FGF-1 is a safe and efficacious therapy to stimulate the production of durable new arteries in the legs of rabbits. FGF-1, as a potent angiogenic growth factor, has the potential to be developed into an important new treatment for CLI. The US Government National Institute of Health (NIH) estimates two million Americans suffer from CLI, and an estimated 40 million worldwide, a major health issue.

Link: https://www.zgm.care/cli

2) Human Fibroblast Growth Factor 1 (FGF-1) for the Treatment of Diabetic Foot Ulcers. FGF-1 has shown remarkable efficacy in closing chronic diabetic ulcers, both in diabetic animal models of wound healing and in FDA-authorized clinical trials. In a Phase IIb trial sponsored by Merck, FGF-1 closed 100% of all ulcers treated over a 5-month period whereas roughly only 40% of the ulcers closed in the placebo arm. FGF-1 is a potent wound healing agent and has the potential to be developed into an effective treatment for diabetic foot ulcers. It is estimated that 10 million to 30 million people develop diabetic foot ulcers every year.

Link: https://www.zgm.care/ulcers

  1. Breakthrough Treatment of Severe Coronary Artery Disease with FGF-1:

Results from Four Human Studies. In the U.S. it is estimated that up to 500,000 subjects suffer from severe coronary artery disease (CAD) for which no medical or surgical options exist, a group which has been referred to as “No-Option Heart Patients”. In this class of patients, FGF-1 has been shown to be a potent stimulator of therapeutic angiogenesis in ischemic heart tissue, significantly relieving these patients of their angina (chest pain) and allowing them to enjoy a much higher quality of life. It is estimated that worldwide, 50 million people have severe coronary artery disease, which we believe only FGF-1 can treat.

Link: https://www.zgm.care/cad

4) Parkinson's Disease: Therapeutic Angiogenesis as a Disease Modifying, Breakthrough Therapy? To date, over 150 patients with Parkinson’s disease have been treated with an intranasally-delivered formulation of FGF-1. The drug has proved to be extremely safe, with little to no adverse events reported by the patients. Motor skill testing has revealed that over 95% of patients who have been treated with FGF-1 show an 18-82% improvement in their motor skill activities. In addition, a significant enhancement of cognitive function has been seen in almost all treated patients.

Link: https://www.zgm.care/pd

5) Lung Damage from Covid-19, Emphysema, Asthma, COPD, and More — Can Inhaled FGF-1 be a Viable Treatment? Globally, the 3rd leading cause of death results from respiratory disorders, accounting for approximately 11% of all deaths worldwide. A large majority of those dying from respiratory disorders will have lung damage. Members of the fibroblast growth factor family, including FGF-1, FGF-2, and FGF-10, are all potent stimulators of lung epithelial cell proliferation and have shown success in reversing lung damage in animal models of viral pneumonia. In addition, members of the FGF family have shown lung-protective activities when administered to patients with emphysema and chronic obstructive pulmonary disease (COPD), which make growth factors such as FGF-1 an attractive candidate to treat Covid-19 induced lung damage.

Link: https://www.zgm.care/lung

6) Stroke, Dementia, and Alzheimer’s Disease: Vascular Disorders of the Brain. Clinical Description and Possible Breakthrough Therapies. It is well recognized that blocked arteries in the brain lead to stroke, but it has only recently been appreciated that vascular dysfunction in the brain is a very early step in the development of Alzheimer’s disease and dementia. If all these diseases are primarily vascular diseases, then new therapeutic options, such as FGF-1, that stimulate new vessel growth would be an attractive candidate for clinical testing.

Link: https://www.zgm.care/stroke

7) Human FGF-1 as a Potential Treatment for Multiple Sclerosis (MS). A review of the medical literature supports the idea that a chronic lack of blood flow and “leaky” brain capillaries may underlie the development and progression of MS. A therapeutic agent such as FGF-1, that can regenerate and heal the damaged microvasculature could represent a novel disease modifying agent for the treatment of MS.

Link: https://www.zgm.care/ms

  1. Chronic Depression: Treatable with Therapeutic Angiogenesis?

Depression, one of the most prevalent and life-threatening forms of mental illness, affects about 21% of the world’s population and more than 20 million people in the United States. Powerful new imaging techniques that can accurately quantify the flow of blood have documented the dramatic decrease in blood perfusion in specific areas of the brain in individuals suffering from chronic depression. Zhittya believes that “therapeutic angiogenesis”, induced by FGF-1, has the potential to correct this lack of blood flow in patients with chronic depression and be a successful treatment for this devastating mental illness.

Link: https://www.zgm.care/depression

Conclusion by Dan Montano

I want to thank the readers of our Monthly Updates for taking the time and having the patience to read what we prepare. Some readers tell us they love the number of details we provide, some readers say it is not enough, and others want it all to be summarized into one paragraph.

As you can see from Dr. Jacobs’ section, we have worked on many more medical indications than we have discussed in our recent Monthly Updates.

I believe we will be accelerating our progress, as we obtain more data from test subjects and more clearance to conduct additional Medical Research Studies.

With the results of our new animal studies (I hope with the same results as all the identical animal trials we have done before) that the USA FDA applications to treat heart disease, Parkinson’s disease, DFUs, and more will be looked upon favorably. I hope in 2025 we will have numerous Investigational New Drug (IND) applications advancing through the USA FDA towards approval. We know the medical need is great, and we know 95% of the sufferers need medical insurance to obtain the treatment. I also believe that once we have FDA approvals that the medical insurance providers will quickly authorize our treatment as the “standard of care” over the presently existing standard of care, since our treatment is better for the patients (safer and better outcomes) and should lower the cost of treating those medical indications by 50% to 75%. That should make patients and insurance companies happy. Only established Big Pharma will be upset with us, since they will lose billions of dollars from their present profit! People always tell me Big Pharma will crush us, and I have been hearing those stories since the 1970s when I was financing new computer start-ups. I was told, “Dan, your new computer company cannot succeed against IBM”. That was the standard wisdom then, and yet we did succeed, time and time again.

Zhittya’s FGF-1 molecule triggers the body's natural bioprocess to regenerate itself. I believe it is the biggest medical breakthrough of the last 100 years and will enhance the lives of millions of people suffering from heart disease, brain disorders, lung disease, diabetes and more.

Zhittya will never quit, Zhittya will never sell out, Zhittya will always push to care for those people who need us to succeed. Will it be fast? No! Will it be easy? No! But Zhittya will get there since we know millions of lives rest in our success, and we will not betray them!

So many great people have stepped forward to help us, and I thank God every day for you. Your efforts have shown us the way and given us the strength to continue when all doubt us. Success is not the absence of failure; it is the conquest of failure!

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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