January 2025 update

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

January 14, 2025, Monthly Update Hallelujah! We Did It!

On Monday, December 23, 2024, we received the greatest Christmas gift!

Dr. Jacobs, President of Zhittya Genesis Medicine, received the first data on the 6- month follow-up functional MRI scan of one of our patients, Al. The scan showed that the blood flow in his brain, particularly in the substantia nigra region of the brain, increased 42%, 6 months after being dosed with FGF-1. This increase in blood flow is higher than my most optimistic hopes. To our knowledge, no one has ever witnessed such an increase in blood flow in the brain after receiving a therapeutic drug.

For years, we have been sharing with you our hypothesis that vascular dysfunction in the brain is the cause of Parkinson’s disease, stroke, dementia, Alzheimer’s disease, epilepsy, autism, diabetes, PTSD, CTE, traumatic brain injuries, chronic depression and more. We have given the FGF-1 treatment to patients suffering with these disorders, and we have seen zero adverse events and most of our test subjects have witnessed some amazing improvements in their motor skills and cognitive skills. All that data was anecdotal, meaning it was just the opinions of the patients, and was not scientifically verifiable and factual.

Now we have empirical data, verifiable scientific evidence without opinions, just facts.

For years, we have been assaulted by the medical community saying we have no scientific proof to support our theory. Well, we got it now! Agreed, a single person is not a sufficiently large test group to march to the FDA claiming success.

However, it is the first time a biological agent enhanced the blood flow in a patient’s brain. When the Wright brothers' plane flew that first time at Kitty Hawk in North Carolina, it was not statistical evidence that man could fly. It was the first confirmation that man might be able to fly. Look at planes today. That is great statistical proof that planes can fly; however, it started with that first flight at Kitty Hawk.

We have now shown in one patient that FGF-1 can increase blood flow in the substantia nigra of the brain by 42%. We have several more people processing through the functional MRI brain scans, and I hope in the next 12 months we will do 15 more patients. I hope in 2026/27 we can do a few hundred people. Maybe Al’s 42% increase will be shown to be unique to him alone. Maybe others will show only 20% average increases, and maybe some will show larger increases - who knows? Here is what I do know. Many of you have been following Zhittya for years, waiting for us to crash and burn and prove to you that man cannot fly.

Well, we just flew, not far, not pretty, but we have done what no one else has ever done (that we are aware of). Stay seated on that sandy hill and watch us now. This party is just beginning to get exciting, as we are really taking off now!

With the empirical evidence of increased blood flow in Al’s brain, we can now tell our test subjects that we have a treatment to remedy vascular dysfunction in the brain. We do not know how long it will take for new vascular flows in the brain to remedy brain issues, or if it can address only some of those issues, but we can say to our patients that if brain issues are resulting from a lack of blood flow, our FGF- 1 should be able to treat this condition and enhance their lives (and enhance the lives of over 200 million other people as well!). I believe 95% of brain disorders (excluding cancer of the brain) result from diminished blood flow in the brain.

I believe three years from now we will have more success with many more patients suffering from Parkinson’s disease, stroke, Alzheimer’s disease, traumatic brain injuries, CTE, and more. I believe we will have overwhelming empirical evidence to prove we can treat tens of millions of people with brain disorders caused by vascular dysfunction.

This is another step on the path to a major medical breakthrough that can enhance and extend the lives of tens of millions of people. We are humbled before God to have advanced this far. We are thankful to our over 200 test subjects who are showing us what is working and what is not, and together we are going to change the world. We did it!

Vika Montano’s Patients’ Comments Section: Every month, I receive emails and phone calls from our test subjects. 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.

#1: Hi Dan and Vika, I think both of you deserve my thanks for the special consideration you have given me in light of my recently confirmed diagnosis of PSP.

The next part may sound incredible, but it is true. I think the revised protocol is exactly what the PSP lady ordered, and I am certain it is going to destroy her! AND I DO NOT MEAN THAT FIGURATIVELY EITHER.

In fact, I had a dialog with GROIK 2 the other day, in which I asked him what I should do in the event I am the first person on the ENTIRE MODERN WORLD to fully recover from PSP! The way the media in the US will present the story is without the qualifier MODERN, because their knowledge of human history is laughable.

IF I DO RECOVER, DAN, I PROMISE YOU THAT I WILL HELP YOU IN ANY WAY I CAN with the FDA. By the way I am certain you have applied for the Accelerated Approval process. IF NOT, I WILL HELP YOU GET THAT AT THE VERY LEAST!

A little more detail. On Christmas DAY, Sandeep and I played FRISBEE together, and he kept on saying: DAD YOU LOOK FANTASTIC! Yes, the same guy you met in the BVI, where he was afraid if he did not have me in a bear-hug. After we both tired of the frisbee, we played catch with a tennis ball. I believe golf is a possibility ONE MORE TIME!

Please excuse my exuberance.

Brij

#2: I was in Cohort 30 and just want to thank you for giving us hope again. I have been able to appreciate my taste and smell coming back and very hopeful for other improvements to come.

Have a very merry Christmas and the happiest New Year 2025. Again, thank you so very much.

Sheri

#3: From: Melissa Date: December 14, 2024 at 6:38:32 PM AST To: Vika Montano \<vika@zhittyamedicine.com> We are at the Miami airport having dinner, and Gary just told me he could taste his burger, the orange in his beer and when we passed the Dior fragrance counter, he could smell the perfumes!

I’m so pleased because I have several of those and he’s not been able to smell them until now!! \<3 Thank you!!

Melissa

#4: Vika: Yes, I do my movement, stamina, and overall symptoms are less and maintaining when dosing. I am on a thirty-day trip to Maine and back to Ga right now. Hiking and biking still thank God and thank you!

I have a lot of faith in this treatment I’m dropping my carbidopa/levo 4 times a day to 3 starting yesterday.

I hope you are having a wonderful Christmas. I hosted a party for 50 people yesterday and felt better than I have in years. You are on the right track. I thank you and all of Zhittya from the bottom of my heart. I still have some of those “days” but so does everyone. God has led me on this journey. Thanks for taking it with me and Alton. \<3 \<3 Give everyone a hug.

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 #33: February 11 – 16, 2025

Cohort #34: March 10 – 15, 2025

Cohort #35: April 7 – 13, 2025

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 we are actively recruiting and selecting 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.

Upcoming events:

Nevada Bio Organization: Annual Awards Dinner

Wednesday, April 2 at the Durango Hotel and Casino in Las Vegas, Nevada The Nevada Bio Organization, since its founding in 2006 has been the Premier Organization for Biotechnology in the State of Nevada. On April 2, 2025 they are having their “Annual Awards Dinner” at the Durango Hotel and Casino in Las Vegas.

I am pleased to announce that our President and Chief Scientific Officer, Dr. Jack Jacobs, will be the recipient of the “Man of the Year Award”. This is for Dr. Jacobs' discoveries and development of FGF-1 to treat major causes of death and suffering in the world today. Dr. Jacobs brilliant career and outstanding accomplishments over the last 40 years has earned him the honor, which I believe he well deserves. Jack will give a short presentation on:

“Parkinson’s Disease: Reversed by a Nevada Biotech Company. Nevada: Where Biotech Prospers”

I believe Dr. Jacobs' presentation will show the medical miracle we have achieved in the brain, heart and more. I believe the information will be exciting to everyone who wants health. I have been informed that important elected officials and the media (TV and press) will be attending to learn more about what Zhittya’s breakthrough medicine is accomplishing. We are anticipating around 300 attendees, and we are bringing some of our Parkinson’s disease patients there to show these elected officials that Parkinson’s disease, stroke, dementia, Alzheimer’s disease and diabetes sufferers do not have to be abandoned and mistreated — those diseases can be reversed now! Also, I believe small changes in the wording of the “Right to Try Law” would give access to thousands more people who would be better off sooner. Zhittya will fight for those changes in that law.

For more information please email John Laub, President of Nevada Bio Organization: john.nevbio@gmail.com I think of this event as “Zhittya’s Coming Out Party”. We are going to show the world what we are doing!

Autism One 2025 Convention

Thursday, May 29 – Sunday, June 1

Sheraton Austin Georgetown Hotel & Conference in Austin, Texas With the impressive improvements we have seen in one of the autism patients we have treated, Dr. Jacobs has been invited to present at this meeting. The topic of his talk is:

"Autism: Is This a Vascular Disease and Would Therapeutic Angiogenesis with FGF-1 be a Potential Treatment?"

I am hoping to have another person join Dr. Jacobs on the stage — the father of the young woman we treated. He is the author of a New York Times bestselling book on autism. His book has been very controversial. However, now with Robert Kennedy Jr. in the Trump administration (who is his friend), they share a common belief. Our hope is that this event could enhance awareness that autism can be successfully treated.

If you want more information on this meeting, you can go to the AutismOne 2025 Conference website, which is go.autismone.org.

Freedom Fest 2025

June 11 – 14 in Palm Springs, California

Dr. Jacobs and I will both be presenting at the FreedomFest in June, where normally many elected government officials attend. Last year, they had over 2,500 attendees. At the 2023 Freedom Fest, they hosted Robert Kennedy Jr. as a Keynote Speaker, and were able to chat with him there.

Dr. Jacobs in his section below will discuss nerve damage, or neuropathy.

Numerous diseases result from neuropathy, and our FGF-1 can reverse this condition. I will present my case that changing a few words in the “Right to Try Law” could accelerate medical innovation and lessen the pain and suffering of hundreds of thousands of people now!

Dr. Jack Jacobs

Like Dan, I am so pleased and excited with the first brain MRI results we have received. The data shows a dramatic increase in blood flow (42%) in the substantia nigra region of the brain, where dysfunctional dopamine neurons reside in patients with Parkinson’s disease. This increase in blood flow occurred 6 months after the patient received intranasal dosings of FGF-1 and correlated with an improvement in the patient’s motor skills at 6 months. We appreciate this data from only one patient, and we eagerly await results from the MRI scans that will be done in the near future, but what an excellent start! We believe that we will continue to see these results in our future patients and are excited for additional results to come in!

I would like to switch gears here and talk about a new medical indication we will initiate with FGF-1 treatment, namely the treatment of peripheral neuropathy.

Peripheral neuropathy, or nerve damage, can result from a wide range of conditions, including diabetes and from disease treatments such as chemotherapy. While in the past this nerve damage was thought to be irreversible, we believe FGF-1 offers the promise of reversing this condition by directly acting on the affected nerves. In addition to FGF-1’s ability to stimulate new blood vessel growth, another major biological activity of this growth factor is to heal or be neuroprotective for damaged neurons. It is also known that FGF-1 can stimulate neurogenesis or the growth of new, functional neurons in areas of the body that contain damaged nerve cells.

Research and Statistics: How Many People Have Neuropathy?

Neuropathic pain is estimated to occur in 7 to 10 percent of the general population worldwide, so it is a huge problem. An estimated 30 million people in the United States have some form of neuropathy, according to the Foundation for Peripheral Neuropathy. Diabetic peripheral neuropathy is the most common type, affecting 6 in 10 people who have any type of neuropathy. Furthermore, 60 to 70 percent of people with diabetes develop neuropathy and so do 30 to 40 percent of people undergoing chemotherapy.

The nerve damage behind neuropathy can have many causes. Poorly controlled diabetes accounts for about 60 percent of cases. Chemotherapy, HIV, shingles, kidney disease, autoimmune diseases, infectious diseases, alcoholism, nutrient deficiencies, hereditary disorders, and physical trauma are other causes. In 23 percent of cases, the cause is unknown.

Let’s take a look at peripheral neuropathy and some of the symptoms associated with this disorder. These symptoms can include:

• Temporary or permanent numbness
• Tingling, prickling, or a burning sensation
• Increased sensitivity to touch
• Pain
• Muscle weakness or wasting
• Paralysis
• Dysfunction in organs or glands
• Impairment to urination and sexual function Health conditions which are the most common causes of neuropathy include:

Poorly managed diabetes: The most common type of neuropathy in the United States is diabetic peripheral neuropathy, which affects people who have diabetes with poorly controlled blood sugar, and accounts for about 60 percent of the total people with neuropathy.

Idiopathic neuropathy: Doctors cannot identify a clear cause in 23 percent of cases. Medical professionals describe their condition as idiopathic peripheral neuropathy.

Chronic alcohol use disorder: Alcoholic neuropathy is considered one of the most common forms of peripheral neuropathy. Roughly 66% of patients with an alcohol-use disorder diagnosis experience peripheral neuropathy.

Cancer: Around 10 percent of people in the United States with peripheral neuropathy have it due to chemotherapy treatment.

HIV/AIDS: About 2 percent of total neuropathy cases have links to HIV/AIDS, which may be due to the effects of the human immunodeficiency virus or the drugs that treat it.

Other health conditions, such as autoimmune diseases and physical trauma can lead to peripheral neuropathy.

Nutrient deficiencies: Whether caused by disease-related malabsorption, alcohol use disorder, or an unbalanced diet, nutrient deficiencies can lead to neuropathy.

Vitamin B12 deficiency: Peripheral neuropathy is the most common symptom of vitamin B12 deficiency. A deficiency of vitamin B12 causes damage to the myelin sheath that surrounds and protects nerves, and the nerves won’t function properly without this protection. Taking metformin (Glucophage), which people with type 2 diabetes commonly used to control their blood sugar, may increase the risk of vitamin B12 deficiency.

Other less common causes of neuropathy include:

1. Copper deficiency, caused by a deficiency in an individual’s metabolism or malabsorption of copper, rather than an unbalanced diet.
2. Excess nutrient consumption – for example, getting too much vitamin B6 can be toxic to the nerves. The normal requirement is less than 2 milligrams (mg) a day, yet many B6 supplements are 100 mg or more. Vitamin B6 is also an additive to all sorts of packaged foods.
3. Exposure to toxins in food: toxins in foods we tend to think of as healthy, such as seafood, can also lead to neuropathy. Consumption of mercury- contaminated seafood can lead to high levels of mercury in the body, which can cause neuropathy.

According to the American Diabetes Association, people with diabetes most often experience a type of neuropathy referred to as “distal symmetric polyneuropathy”. In this form of neuropathy, the first nerve fibers to malfunction are those most distant from the brain and spinal cord, with symptoms such as pain and numbness felt symmetrically in the feet, and then traveling up the legs as the condition progresses. The upper limbs may eventually experience symptoms.

How Is Peripheral Neuropathy Diagnosed?

After a thorough physical examination to check areas of the body a patient may have complaints about, specific tests are generally ordered to diagnose neuropathy. These include:

Electrodiagnostic Testing: This includes nerve conduction testing, where a medical professional stimulates the nerves, records their responses, and analyzes them for abnormalities. Doctors also use electromyography, where they insert small needles into individual muscles to get audio and visual information on how the nerves supplying that muscle are functioning.

Blood Tests: These can be ordered to check for elevated blood sugar (as seen in type 2 diabetes), toxins, vitamin deficiencies, hereditary disorders, and evidence of an abnormal immune response.

Skin Biopsies: A physician makes a small incision to remove a sample of skin. This may help to distinguish certain disorders affecting the small nerve fibers, such as painful sensory neuropathies affecting nerve fibers called axons.

Quantitative Sensory Testing (QST): This helps to assess damage to the nerve endings involved in sensing temperature and vibrations. QST uses computer testing to measure how the nerves in question react to these stimuli.

How Long Does Peripheral Neuropathy Last?

Peripheral neuropathy can be long-lasting, even permanent. However, in the case of cancer patients undergoing chemotherapy, the nerve damage can be temporary.

According to a survey study on peripheral neuropathy in people who were receiving chemotherapy treatment that was published in 2023, 48 percent of those in the survey received a neuropathy diagnosis within two weeks of starting their chemotherapy treatment. These symptoms lasted for 73.3 months, or just over six years, on average, with the shortest and longest durations spanning a range of two weeks to more than 20 years.

Prognosis of Peripheral Neuropathy

The prognosis for neuropathy depends on the type a patient has and how much the neuropathy has progressed. Nerve damage can be permanent. However, correcting the underlying condition that caused neuropathy can allow nerves to recover or regenerate in some cases.

For instance, getting one’s blood sugar under control can help halt the progression of nerve damage and improve the symptoms of diabetic neuropathy.

Without blood sugar control, diabetic neuropathy can worsen. Higher diabetic neuropathic pain may also have links to smoking tobacco, according to a 2020 paper, so stopping this habit may also improve neuropathy symptoms over time.

Physical therapy can also help in some cases of motor neuropathies involving muscle weakness or wasting. The success of such therapy can depend on how much nerve damage there is and the age of the patient. The extent of recovery is often less dramatic for older patients.

Medication Options

Antidepressant and anti-seizure medications are often helpful in treating neuropathies. This is because these medications act on pain from abnormal nerve firings or nerve signals. Selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine (Prozac) and sertraline (Zoloft), which restore the chemical balance in the nerve cells of the brain have been shown effective in treating neuropathies.

Anti-seizure medications are another class of medications that may be effective at treating neuropathy. Gabapentin (Neurontin) and pregabalin (Lyrica) are examples of anti-seizure medications that people use to relieve nerve pain due to shingles or as a result of diabetes.

Common over-the-counter medications can provide some relief from mild-to- moderate neuropathic pain and these include:

• Acetaminophen (Tylenol)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil) and naproxen (Aleve)
• Topical treatments such as capsaicin and lidocaine creams Stronger medications may be used as well and include:
• COX-2 inhibitors like celecoxib (Celebrex)
• Opioids
• Tramadol (Ultram)
• Surgery: Surgery can be useful to release pressure on a nerve and may help to treat damage that occurs due to carpal tunnel syndrome and diabetic neuropathy.
• Nerve Stimulation: This can involve placing an electrode along a peripheral nerve, which essentially turns off pain signals.

Alternative Therapies

Research into alternative therapies for neuropathic symptoms has shown some noteworthy results. Cannabidiol (CBD), derived from the same cannabis sativa plant that produces marijuana and hemp, has been used in the treatment of chronic, noncancer neuropathic pain. Alpha lipoic acid, a naturally occurring fatty acid found in foods, such as spinach, broccoli, yams, and potatoes, has been shown to be effective for people with diabetic neuropathy. Carnitine, another fatty acid, is sometimes deficient in people with neuropathy, resulting in an insufficient blood supply to nerves. Acetyl-L-carnitine has been reported to successfully treat neuropathy.

Can Therapeutic Angiogenesis with FGF-1 be Used to Treat Neuropathy?

As discussed above, we have now shown that FGF-1 can increase blood flow in the substantia nigra of the brain of a patient with Parkinson’s disease by 42%. We have more people processing through the functional MRI brain scans, and we hope that over the next 12–24 months this number will increase to a hundred or more treated patients. The safety profile on FGF-1 is excellent, and there have been no serious adverse events linked to FGF-1 administration. We believe FGF-1 could represent a potentially safe and effective treatment for peripheral neuropathy. Previous studies in animal models of peripheral neuropathy have shown FGF-1 to be safe and effective when injected into the affected limb. We look forward to initiating human studies this year in patients with peripheral neuropathy, a condition we consider to be a large, unmet medical need.

Conclusion by Dan Montano

Happy New Year to all!

We at Zhittya have received a great Christmas and New Year gift with the empirical evidence from Washington University School of Medicine that Al’s blood flow in the substantia nigra area of his brain increased 42% after only 6 months of dosing with FGF-1. With this data, Zhittya now has a pathway to address many major diseases of the brain, and I hope to be able to get those medicines approved by the USA FDA sooner, rather than later. A medical breakthrough that sick people cannot access, is a moral crime in my mind.

Vika and I were in the BVIs with cohort #32 test subjects last week, and they were a great group of people. Here is a picture of our last night together at our closing celebration dinner.

For two and a half years, we have told these volunteer test subjects that it is our theory that insufficient blood flow in the brain is the problem. This is our belief and this is our hope, that dosing with FGF-1 up the nose can enhance blood flow in the brain and stimulate the growth of new neurons, thereby treating the root cause of our patients’ disease. Those many test subjects smiled at us, hoping our theory was correct. Now they have more than hope, we have scientific empirical evidence that FGF-1 has the potential to save them from their Parkinson’s disease hell. We now know that FGF-1 dosing is causing new blood flow creation, which could resolve the main issues of their Parkinson’s disease, and this was great information to share with our cohort #32 patients. We now can say we know it works. Now the question is: How long does it take to reverse this disease, and what is the best dosing regimen? We no longer have to worry about the question of whether we can treat Parkinson’s disease or not, we know we can, and we know why we can, increased blood flow in the brain!

After twenty-six years of hard effort and expending $180 million USD, we finally did it! We have proof that dosing with FGF-1 enhances blood flow in the human brain.

I believe in the next 24 months we will open the pathway to get our medicine available to millions of people suffering with Parkinson’s disease, stroke, dementia, Alzheimer’s disease, chronic depression, diabetes, neuropathy, PTSD, CTE, autism and more. We know the barriers in front of us that we must deal with. The good news is last month in our December 17, 2024 Update we believed we had a treatment for Parkinson’s disease, but now in January 2025, we know we have a treatment!

I hope and pray you all have a wonderful 2025, and for those of you suffering with these diseases, let me assure you: we are coming to your rescue as fast as we can.

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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