Frequently Asked Questions (FAQs)
How long is the research?
Currently, Zhittya is conducting treatment research over the course of 7 days.
Where is the research available?
All research is currently being done in the British Virgin Islands (BVI). Although Zhittya is actively working on opening research opportunities in other countries, there are no current alternatives for the BVI.
How long are the expected effects?
In theory, one research study should be enough to last for 5-12 years or longer, depending on the lifestyle of the patient and the underlying reason that the Parkinson's Disease developed. It is important to note that Parkinson's Disease and many other neurodegenerative disease are diseases of aging and systemic, implying the need for follow-up studies and possible treatments.
How quickly will one receive possible effects?
From our current studies, the first symptoms of recovery could be observed in 2 to 3 weeks. However, some patients experienced a reported relief in their symptoms in as little as 3 to 4 days. From our previous clinical trials in the human heart, it took 3-12 weeks for the new blood vessels to grow in these patients, we believe it even longer to grow new neurons in the brain of Parkinson's Disease sufferers.
What is FGF-1?
FGF-1, Human Growth Factor 1, is a powerful growth factor that stimulates the natural process of new blood vessel growth in your body. The growth factor already circulates in your system at very low levels. However, every time one suffers an acute injury, the body produces FGF-1 in an attempt to heal the wounded site. Through the process of new blood vessel growth (angiogenesis), FGF-1 is believed to also grow new bone, neurons, skin, hair, sweat glands, and various other tissue that is needed in order to heal the wounded site.
FGF-1 is native to the human body. Why did it not treat my Parkinson's Disease already?
Parkinson's Disease and other neurodegenerative diseases develop slowly and do not have an acute traumatic event. By artificially introducing FGF-1 to ischemic and dying tissues, we believe that we can recreate the natural process of healing in the body.
Why does Zhittya believe FGF-1 may help more than current drugs on the market for Parkinson's Disease?
There are numerous studies that point out that Parkinson's Disease patients have a 50%-75% decrease in brain blood perfusion compared to that of a health individual. These studies utilized functional MRI to measure regional blood flow in different areas of the brain. This lack of blood flow is seen in areas of the brain responsible for movement including the substantia nigra, striatum, cerebellum, and other areas. In areas of the brain containing dopamine-secreting neurons and areas controlling movement, scientists were able to observe diminished blood flow due to the death or blockage of capillaries, that, in turn, triggered the death of the neurons from lack of nourishment and inefficient removal of metabolic waste products. This lack of blood flow led to the onset of the symptoms of neurodegenerative disease. We believe that our FGF-1 is a powerful trigger for the growth of new blood vessels. By addressing the underlying cause of the disease through the possible growth of new blood vessels, we believe we can resupply dormant or dying neurons with oxygen and glucose thereby making them functional again. In addition, we also believe that the presence of these new blood vessels will stimulate stem cells in the brain to grow and differentiate into healthy new nerve cells to repopulate areas that have been depleted of neurons.
How is FGF-1 targeted?
We believe that FGF-1 only triggers blood vessel growth in ischemic tissues, regardless of where they are through the cellular process of upregulation. FGF-1 only binds to upregulated FGF-1 receptors on cells lacking proper nourishment, on cells that are completely healthy, FGF-1 would not bind and thereby have no effect.
What is the delivery method of FGF-1?
Currently, our FGF-1 is being delivered into the brain via the nasal cavity with the help of a special intranasal delivery device.
Why intranasal delivery?
In our experiments with animals, it demonstrated that a greater amount of drug was delivered into the brain via intranasal delivery when compared to an intravenous delivery. Furthermore, by delivering the drug via the nasal cavity, we avoid crossing the blood-brain barrier, as the FGF-1 travels into the brain along the olfactory and trigeminal nerves.
Can FGF-1 trigger cancer?
As of date, we have treated over 80 patients with severe heart disease with FGF-1 and no patient has developed cancer or saw an increase in serum tumor markers. In addition, in earlier studies where over 100 patients were treated with topical formulations of FGF-1 for the treatment of chronic diabetic foot ulcers, no evidence of cancer formation was seen. Moreover, in long-term animal toxicity studies, no initiation of cancer was seen in rodents or dogs.
How long should one be at the research site?
One should plan on staying for 8 days. The first day is an arrival day and to allow individuals time to settle in. That first day is then followed by 7 days of daily treatment given at approximately 9 AM each day. The first day of the treatment will be the longest one, because we will take a fasting blood sample for lab analysis. On the first day of treatment, prior to drug dosing, we will also conduct verbal and physical tests related to one's Parkinson's Disease symptoms. A blood sample for lab tests will also be taken after the last dosing period and you can leave immediately after this if you wish. Zhittya will conducts follow-up interviews 30 days, 6 months, and 1 year after treatment.
What happens if one does not recover as much as other patients in the studies?
As a research study, Zhittya is attempting to find the best dosage strength and length of treatment regimen. If Zhittya finds that one treatment method proves to be significantly more efficacious than another, Zhittya will offer space in a future research study with this new treatment method to former patients at no cost to the patient.
Why does Zhittya believe that recovery will take so long?
It takes years to develop Parkinson's Disease, meaning that it will likely take a proportional amount of time to possibly recover from Parkinson's Disease. Just as a stroke sufferer takes years to relearn and rehabilitate themselves, it may take years for possible recovery to accumulate for Parkinson's Disease sufferers enrolled in this research.