June 23rd at 3:00 PM Pacific time (6:00 PM Eastern time).
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Zhittya Genesis Medicine
June 2022 Update
Completed: Parkinson’s Disease Medical Research Study Using Intranasal Delivery of FGF-1: First Look at the Human Data
Test Patients at the 30-day Assessment Had a 50% Improvement in Motor Skills
Zhittya Intranasal Development Corporation (ZINC), a subsidiary of Zhittya Genesis Medicine, initiated its “Medical Research Study” starting May 3, 2022, to treat patients with Parkinson’s disease. The dosing phase of the study concluded on May 30th.
The primary focus of this June Update will be to discuss this “first-in-human” study, where we examined the safety and effectiveness of “nose-to-brain” delivery of FGF-1 to treat Parkinson’s disease. Data presented will be current as of the date of June 14, 2022.
The Parkinson’s disease test subjects started their intranasal dosing of FGF-1 on May 3rd. The 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; they continued this daily intranasal dosing for 14 days (the last day of this level of dosing was on May 16th). The test subjects then entered a one-week period of observation and testing, where no drug was administered. Seeing no adverse events after 7 days from the first round of dosing, a second round was initiated.
The following week the test subjects received a “high” dose FGF-1 administration (double the low dose or a total of 900 µg of FGF-1 per day) starting on May 24th and on May 30th the final dose was administered. On June 1st, an examination was conducted which assessed the status of their Parkinson’s disease cognitive and motor skills.
As for safety of the treatment, as of June 14th, we are pleased to announce that the Principal Investigator of the study has not observed or been informed by the patients of any adverse events.
Concerning possible benefits of the intranasal FGF-1 treatment, on June 23, 2022, Zhittya will present safety and efficacy data in a Zoom webinar to the public. That Zoom webinar will include video (before & after treatment) and interviews with two of the test subjects. We will let the viewers of the videos be the judge if they think there is any sign of improvement in the patients after being treated with FGF-1. Dr. Jacobs also addresses this topic later on in this Update.
This is the first of many Medical Research Studies which Zhittya will conduct in a Parkinson’s disease population to learn if our drug candidate is safe and effective in enhancing the condition of Parkinson’s disease sufferers. At this time, with the data that is currently available, we believe that the medicine is safe and that it is showing tantalizing hints of success. This is still early-stage data; however, we believe the data is very promising so far.
I would also like to report that I (Daniel Montano) personally started intranasal dosing at the low level of FGF-1 on May 8th. After seven days of dosing, I paused for 2 days and then on May 17th started taking the high dose of FGF-1, which I took for seven days, ending May 24th. I have noticed absolutely no adverse effects.
On May 24th my wife, Viktoriya Montano, started taking the low intranasal dose of FGF-1 for 14 days. On June 7th, she completed the 14-day dosing regimen and like me, she reports no adverse events, whatsoever.
We want to emphasize from the study with the monkeys given FGF-1 to reverse their experimental Parkinson’s disease, that it took almost 7 months for the animals to regain around 85% to 90% of their normal motor skills back. However, the animals did show some improvement in their motor skills during the first 30 days after their dosing started, when compared to animals that received a placebo dose. The time period that corresponded from day 45 to day 90 after FGF-1 dosing was initiated is where the most visible improvement in the animals’ motor skills occurred. The monkeys continued to have steady improvement following the 90-day time point over the next four months, at which point the study was terminated (7 months total) and the question of continued improvement was not addressed.
We pray that our human test subjects will show a similar type of improvement. 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.
Our first concern in this Medical Research Study is safety. As of June 14th, I am very confident the medicine at the levels we are dosing at is safe. I can make this statement from my own personal experience and my wife’s experience with intranasal dosing of FGF-1. We will now be closely following possible additional improvements in the patients’ Parkinson’s disease condition.
VERY IMPORTANT
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 from the human test subjects 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.
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