Parkinson's Disease-Medical Research Study- First Look at the Data from Intranasal Delivery of FGF-1
Date & Time Jun 23, 2022 03:00 PM Pacific Time (US and Canada)
Webinar ID 832 3187 5475
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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 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.