Parkinson's disease is a progressive neurological disorder characterized by a gradual loss of nerve cells in the brain, specifically those that produce dopamine. This loss of dopamine leads to a variety of symptoms, primarily affecting movement but also impacting other areas like cognition, mood, and sleep.

Zhittya was cleared in 2022 to conduct human research studies using FGF-1 in the British Virgin Islands. Since then, Zhittya has reported that it has treated over 200 Parkinson’s patients using a nasal inhaler to deliver the drug into the brain across the blood-brain barrier.  Zhittya has  publicly reported (in a press release dated February 27, 2025) that Parkinson’s patients enrolled in a two and one-half year study, receiving intranasal FGF-1 therapy exhibited an average 54% improvement in motor skills within six months of treatment.

Recent research in 2020 titled, “Vascular, flow and perfusion abnormalities in Parkinson's disease” in the journal Parkinson and Related Disorders noted that Parkinson’s patients have less blood flow to the part of the brain that has the dopamine-producing neurons.

Zhittya also reported that in a study at Washington University School of Medicine, a fMRI study that showed a 21.2% increase in brain blood flow in a Parkinson’s patient after just six months of intranasal FGF-1 therapy and these changes correlated directly with the patient’s physical health culminating in a 50% improvement in motor skills as measured by standardized clinical tests.

Studies have also shown positive data with FGF-1 in several animal models, including peer-reviewed publications in rodent and primate models of Parkinson’s disease, as described below. In the publication Neurotoxicity Research, the article by McLay et.al, “Administration of FGF-1 Through Transfected Cells Alleviates MPTP Toxicity in Mice”, demonstrated that the implantation of fibroblasts genetically modified to secrete fibroblast growth factor-1 (FGF-1) increased striatal dopamine concentrations in a 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-treated mouse model of Parkinson's disease. In addition, in the American Journal of Translational Research, the article by Wei et.al., “Fibroblast Growth Factor 1 Attenuates 6-Hydroxydopamine-Induced Neurotoxicity: An In Vitro and In Vivo Investigation in Experimental Models of Parkinson’s Disease”, demonstrated that FGF-1 administration improved the motor function recovery, increased the tyrosine hydroxylase-positive neurons (TH) survival and up-regulated the levels of neurotransmitters in rats with experimental Parkinson’s disease. In another peer-reviewed publication by deYebenes et. al., appearing in the journal Parkinsonism and Related Disorders, human fibroblast growth factors (FGF-1 and FGF-2) were able to reverse the motor skill decline seen in monkeys with experimentally induced Parkinson’s disease. Placebo-treated animals continued to see a decline in their motor skills scores. Of particular importance was the finding that in the FGF-1 treated monkeys, there was a regeneration of new dopamine-secreting neurons in the brains of those animals. In addition, a reduction of toxic plaque was noted in the brain and no serious adverse events. The authors concluded that these two human FGFs, by stimulating the growth of new dopamine neurons, led to the reversal of the classical Parkinson’s disease motor skill deficits (such as tremors, jerkiness, and gait disturbances) seen in this primate model.

Figure 1 is a graph showing data from “Long-term intracerebral infusion of fibroblast growth factors restores motility and enhances F-DOPA uptake in parkinsonian monkeys” by deYebenes, et.al, that appeared in the journal, Parkinsonism and Related Disorders and improvement in motor scores of monkeys with FGF-1.

Figure 2 is a picture from “Long-term intracerebral infusion of fibroblast growth factors restores motility and enhances F-DOPA uptake in parkinsonian monkeys” by deYebenes, et.al, that appeared in the journal, Parkinsonism and Related Disorders and shows more dopamine in the brains of monkeys with FGF-1.

Figure 3 is from “Fibroblast Growth Factor 1 Attenuates 6-Hydroxydopamine-Induced Neurotoxicity: An In Vitro and In Vivo Investigation in Experimental Models of Parkinson’s Disease,” by Wei et al., which appeared in the American Journal of Translational Research, shows that the reduction of alpha synuclein plaques with FGF-1.

Zhittya’s Treatment

Zhittya’s planned treatment is to treat the patients with twice a day, doses of FGF-1 with a nasal inhaler for six days and then re-dose those patients every three months for two years. As noted on Zhittya’s website,  Zhittya has been conducting medical research studies with humans in the British Virgin Islands having dosed over 200 patients as of May 2025, where the average patient reported a 53% improvement in motor scores.

Research Papers and Additional Reading:

1. Neurotrophic factors for the treatment of Parkinson’s disease. Sullivan AM and Toulouse A. Cytokine Growth Factor Rev 2011; 22: 157165. (Link: https://www.ncbi.nlm.nih.gov/pubmed/21689963)

2. Neurotrophic factors for the treatment of Parkinson’s disease. Chiocco MJ, Harvey BK, Wang Y and Hoffer BJ. Parkinsonism Relat Disord 2007; 13 Suppl 3: S321-328. (Link: https://www.ncbi.nlm.nih.gov/pubmed/18267258 )

3. The FGF family: biology, pathophysiology and therapy. Beenken A and Mohammadi M. Nat Rev Drug Discov 2009; 8: 235-253. (Link: https://www.nature.com/articles/nrd2792)

4. Fibroblast growth factors enhance dopamine fiber formation from nigral grafts. Giacobini MM, Stromberg I, Almstrom S, Cao Y and Olson L. Brain Res Dev Brain Res 1993; 75: 65-73.(Link: https://www.ncbi.nlm.nih.gov/pubmed/7693370)

5. Long-term intracerebral infusion of fibroblast growth factors restores motility and enhances F-DOPA uptake in parkinsonian monkeys.de Yebenes JG, Pernaute RS, Garrido JM, Rabano A, Albisua J, Rojo A, Mena MA, Ruiz PG, Jorge P, Correa C, Leenders K, Antonini A, Gunther I, Psylla M and Vontobel P. Parkinsonism Relat Disord 1998; 4: 147-158. (Link: https://www.ncbi.nlm.nih.gov/pubmed/18591105 )

6. Administration of FGF-1 through transfected cells alleviates MPTP toxicity in mice. McLay RN, Freeman SM, Zadina JE. 2001.. Neurotox Res 3:249–253. (Link: https://www.ncbi.nlm.nih.gov/pubmed/15111249 )

7. Fibroblast growth factor 1 attenuates 6-hydroxydopamine-induced neurotoxicity: an in vitro and in vivo investigation in experimental models of Parkinson’s disease. Wei1 X, S He, Z Wang, J Wu, J Zhang, et. al. 2014. Am J Transl Res 2014;6:664-677.(Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4297335/ )

8. Human Hippocampal Neurogenesis Persists throughout Aging. Boldrini M, Fulmore CA, Tartt AN, et al. 2018. Cell Stem Cell 22:589–599. (Link: https://www.ncbi.nlm.nih.gov/pubmed/29625071 )

9. Zhittya press release, “Brain Blood Flow in Parkinson’s Patient Following Six Months of Intranasal FGF-1 Therapy.” February 27, 2025 https://www.globenewswire.com/news-release/2025/02/27/3034042/0/en/Zhittya-Genesis-Medicine-Announces-Landmark-fMRI-Study-Reveals-21-2-Boost-in-Brain-Blood-Flow-in-Parkinson-s-Patient-Following-Six-Months-of-Intranasal-FGF-1-Therapy.html