Zhittya Genesis Medicine
May 2022 Update
Parkinson’s Disease Medical Research Study Using Intranasal Delivery of FGF-1: First Look at the Data
Zhittya Intranasal Development Corporation (ZINC), a subsidiary of Zhittya Genesis Medicine, initiated its “Medical Research Study” (MRS) this month to treat patients with Parkinson’s disease.
The primary focus of this May Update will be discussing this “first-in-human” study, where we will be examining the safety and effectiveness of “nose-to-brain” delivery of FGF-1 to treat Parkinson’s disease.
This issue of the Update will contain data from the medical research study as of May 19, 2022.
The Parkinson’s disease test subjects started their intranasal dosing of FGF-1 on May 3rd. They continued daily intranasal dosing for 14 days (the last day of dosing was on May 16th). This first phase of dosing was at a “low” dose, where the patients received a total dose of 450 µg of FGF-1 by administering into each nostril a 7.5 second spray. Below is a link to a YouTube video, which will show you two subjects administering their first dose of FGF-1 in the Medical Research Study, as well as dosing on day 8 of the study (May 10th).
Raw data: youtu.be/Q7n9YuEuIpM
The test subjects have now entered a one-week period of observation and testing, where no drug will be administered. This will then be followed by a week of “high” dose FGF-1 administration (double the low dose or a total of 900 µg of FGF-1 per day) starting on May 24th. We are pleased to announce that as of May 19th, no adverse events from the medicine have been observed. Concerning benefit, you be the judge if you think there is any hint of improvement in the patient’s hand tremor in the video. We believe that these safety and efficacy results, although early, are promising.
Again, to reemphasize what we have reported in earlier issues of this Update, we believe from previous human studies in the heart with FGF-1, as well as from examining FGF-1 in animal models of brain disorders, the following biological processes should be occurring in our test subjects:
Angiogenesis: We believe the FGF-1 molecule will trigger angiogenesis within damaged areas of the brain, growing new blood vessels to deliver needed blood flow to stressed brain cells (in Parkinson’s disease, to the dopamine neurons). We believe this process of angiogenesis will start within hours of the FGF-1 reaching the stressed brain cells. We believe (from what we saw in the human heart) that the process of angiogenesis will continue for 3 to 8 weeks.
Neurogenesis: We believe that as the blood flow is enhanced in the brain by FGF-1 stimulating angiogenesis, that the pools of under-perfused neural stem cells (that we all have in our brains naturally), will get the fuel (blood) needed to start to divide, differentiate, and repair the damaged brain. This process, we believe, starts around week two and can continue for 3 to 6 months. This is what was seen in the monkeys who had an experimental form of Parkinson’s disease and were treated with FGF-1.
As mentioned above, dosing at level two (or the high dose) will start May 24th and end on May 30th. Dr. Jacobs and I will fly to the testing location to be with the test subjects when their final dosing occurs and at which point, they will start the last 7-day observation and testing period. We will also have follow-up visits with the test subjects at 60 days (around July 1) and 90 days (around August 1). Our first concern is safety, but we will also be looking closely at possible improvements in the patients’ Parkinson’s disease condition.
Zhittya has scheduled a Zoom webinar presentation on: “Parkinson's Disease-Medical Research Study Using Intranasal Delivery of FGF-1: First Look at the Data”, on June 23rd at 3:00 PM Pacific time (6:00 PM Eastern time).
This Zoom webinar will be to present the accumulated data we have as of June 22nd and where we will have an opportunity to further assess the safety and efficacy of our intranasal FGF-1 drug treatment.
If you wish to attend this free, informational webinar on June 23rd, please go to our website: zgm.care and sign up.
The ease of intranasal delivery of FGF-1 has accelerated our efforts to establish more clinics where we can conduct additional “Medical Research Studies” looking at a wide array of brain disorders. At this time, we believe that the Bahamas, Panama, and Albania may be operational (with government clearance to proceed to dose patients) by June or July. Following those clinics, we believe our applications will be processed to have additional clinics working in Morocco, Dubai, and the Cayman Islands.
Once we see the medicine is safe from our ongoing trial with Parkinson’s disease patients, then here is a list of those new Medical Research Studies we hope to start in the July–August timeframe:
A. Parkinson’s disease: explore different dosing regimens
Study #1: Dosing patients for 14 days at level A or low dose
Study #2: Dosing patients for 14 days at level B or high dose
We suspect that 14 days of low dose administration may be all that is needed to rejuvenate the dopamine neurons in the brain. Remember, this still represents 2.5 times more FGF-1 than the monkeys received. We suspect that excessive FGF-1 which does not bind to FGF-1 receptors in the brain will quickly leave the body within 6 hours. At the low dose level, we may have enough FGF-1 to do the job, which is a hallmark of drug development—namely, finding the lowest dose of the drug that still gives the maximum effect.
B. Parkinson’s disease: explore treatment in subgroup classifications
Parkinson’s disease patients represent a heterogeneous group, with patients at different stages of their disease and on different treatment plans. As our first foray into looking at different subgroups of Parkinson’s disease patients, we will initiate research studies in patients who have tried or are still using deep brain stimulation (DBS).
Study #3: Parkinson’s Disease where DBS has been removed
Study #4: Parkinson’s Disease where DBS is presently in patients
C. Other Brain Disorders: Diseases with few or no treatment options (unmet medical needs).
In past issues of these Updates, we have outlined other brain disorders that we and others believe result from insufficient blood flow to certain areas of the brain, and, therefore, may be amenable to treatment with FGF-1. We are developing Protocols for the following medical research studies where FGF-1 will be delivered intranasally.
Study #5: ALS (motor neuron disease (MND) or Lou Gehrig’s disease)
Study #6: Dementia (study in patients with any form of vascular dementia, including Alzheimer’s disease)
Study #7: Aphasia (Dr. Jacobs wrote about this condition in the April 2022 Update). Aphasia impairs the ability of a person to speak or to understand others. It is estimated that 85% of all aphasia cases are caused by stroke, and we have good evidence in animals that FGF-1 can heal a brain-damaged by a stroke and restore cerebral function.
Study #8: Stroke study in patients who have suffered a stroke and have a permanent disability.
Study #9: Multiple Sclerosis (MS) We have presented evidence in the past that we and others believe MS is a disease of vascular etiology, where leaky blood vessels result in immune cells escaping the circulation and attacking adjacent neurons.
Study #10: Traumatic Brain Injuries (TBI) There is good evidence in animal models of TBI that FGF-1 is a safe and effective therapy in reversing traumatic brain injury.
Thus, in addition to the Parkinson’s disease research study we are now doing in the British Virgin Islands (BVI), we hope to get these 10 additional studies going in July/August, after we have safety and medical outcomes from the first study. This may seem as an overly ambitious agenda, but it should be noted these additional 10 studies will be copies or simple modifications of the first BVI study. These studies are small and can be done quickly. It is conceivable that by September/October 2022, we will have data on safety and patient improvement in all of these new research studies.
The brain disorders we will be treating in the research studies mentioned above are reported to affect 200 million people worldwide. I believe all these diseases have a fundamental similarity in that vascular dysfunction is a primary contributing factor. If FGF-1 can stimulate angiogenesis (growth of new blood vessels), and subsequent neurogenesis to reverse these diseases, then I believe we are onto something important.
Dr. Jack Jacobs:
Comment on 1st Medical Research Study for Parkinson’s Disease
It is so gratifying and exciting to actually be dosing patients again who could benefit from our treatment. We hope this first medical research study with Parkinson’s disease patients can be greatly expanded as additional clinics come on board. We also look forward to trying our intranasal FGF-1 treatment on other brain disorders as well. We have placed our second order for additional intranasal delivery devices with our supplier in Seattle and hope they can deliver the devices we may need. We know like everyone else they are experiencing supply chain issues and their ability to produce devices is still very limited.
As a scientist, I try to make rational calculations on how results from an animal study may be projected to see how likely success could be in a human setting. Let me give you an example of my calculations with our Parkinson’s disease treatment.
We know that in monkeys given FGF-1, the animals showed marked improvement in their motor scores and regenerated new dopamine-secreting neurons in the substantia nigra region of the brain. The FGF-1 was injected directly into the brain in that study at a dose of 2 µg a week for 24 weeks, or a total of 48 µg FGF-1. Since the drug was injected directly into the brain, we will assume it was 100% available for biological actions in the brain.
Now, let's look at the subjects who are participating in our first Parkinson’s disease medical research study and calculate the amount of FGF-1 we are delivering to their brains. We know from the intranasal FGF-1 animal studies that approximately 2% of the FGF-1 that is sprayed into the nose makes it into the brain. From this, we can calculate that during low dosing, we delivered 63 µg of FGF-1 per week into the brain and at the high dosing level, 126 µg of FGF-1 per week. For the entire study, our subjects will receive a total of 252 µg of FGF-1. The weight of the monkeys’ brains used in the above study were approximately 1/20th the weight of an adult human brain, but we can still say that at both low and high dosing in humans, our test subjects received more FGF-1 into their brains, both on a weekly basis and over the life of the study, than the monkeys did who benefitted from this treatment. This is why we are so excited and hopeful that we could possibly see benefits from this treatment.
I should also mention that Dan and I have discussed the scenario where a patient might not receive a clinical benefit in a certain medical research study, but then a subsequent Medical Research Study treatment regimen appears to be successful. In that case, those patients who participated in the earlier research study would be entitled to be treated with what was discovered that worked for their ailment. We believe this is the “Right Thing” to do!
Future Medical Research Studies
Dan laid out above the medical research studies we hope to initiate in the June–August 2022 time span and which deal with various brain disorders. Let me briefly expand on that list and look over additional studies we should be able to start over the next 12-month time frame. Remember, these are small, focused research studies, and except for the heart study, the drug can be easily and non-invasively administered. The following is a list of other disorders we should be treating over the next 12 months. Some of these ideas are not ours, but came from physicians or patients we have met at the various conferences we have attended. I have written White Papers on most of these subjects, and we are happy to send out these papers on request, or you can visit our YouTube channel here: youtube.com/c/ZhittyaRegene... and view about 12 specific medical/scientific presentations on those medical applications.
Medical Research Studies: September 2022–June 2023
Brain:
1. Chronic Depression: An estimated 21.0 million adults in the United States have at least one major depressive episode per year. This number represented 8.4% of all U.S. adults. The normal FGF system within the brain has been shown to be dysfunctional in this disorder and that a person’s natural brain FGF-1 levels, when chronically depressed, become very low. We hope our treatment could reestablish normal levels of FGF-1 in the brain and diminish or eliminate the depressive state.
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