In short
Nearly 200 people with Parkinson's had been dosed. Newer protocols deliver a much larger total dose than the earliest ones, and follow-up brain scans at Washington University in St. Louis were being scheduled.
The November update explained why the team believes the brain needs longer dosing than it first assumed, and looked ahead to a follow-up brain scan.
Why the brain takes longer
CEO Dan Montano wrote that thousands of studies by other researchers over 40 years had shaped Zhittya's understanding of FGF-1. One lesson, he said, is that the body responds more strongly when the receptors for FGF-1 on stressed cells have had time to reset after an earlier dose.
He compared different parts of the body. In earlier research in other areas, he wrote, some tissues were given a single round of FGF-1, while others needed repeated doses over several months. The team had now learned, he said, that the brain needs more dosing, over a longer time.
He pointed to the earlier monkey study, done by researchers outside Zhittya. In it, animals with an experimental form of Parkinson's showed meaningful improvement in motor scores after five to seven months of monthly dosing, given by injection directly into the brain. Zhittya uses a nasal spray instead, and the update said animal work with the University of Minnesota showed that this route can carry large amounts of FGF-1 into the brain.
The update said almost 200 people with Parkinson's had now received FGF-1 in the research studies. The first were dosed about 30 months earlier at dosing Level 1. The team watched for problems, then raised the dose for the next group a few months later.
One rule of the study plan is that any improved dosing schedule is automatically given to participants from earlier groups as well. Participants were now on Protocol 17, which in total is about 40 times more FGF-1 than the first participants received. Mr. Montano wrote that participants had shown greater improvement as they received more FGF-1 over a longer period.
The six-month scan
On December 3, Mr. Montano and Vika Montano planned to be at the Washington University School of Medicine in St. Louis for one participant's six-month follow-up scan, which measures blood flow in the brain. The update said the participant's movement scores and memory had improved. The open question was why.
Mr. Montano wrote that the team still needed scientific evidence of why participants had reported improvement. He hoped the analysis would show more blood flow in the participant's brain than before dosing.
Head injuries and small blood vessels
Dr. Jack Jacobs wrote about the lasting effects of repeated mild head injury, as seen in contact sports and in military service. Symptoms often begin 8 to 10 years later and, in advanced cases, can resemble Parkinson's. He described evidence from autopsy studies and animal models that such injuries damage the brain's smallest blood vessels.
He connected this to other conditions. A McGill University study of 1,171 people with Alzheimer's found that the earliest change was a decline in the small blood vessels. Research at the University of Southern California had led to the hypothesis that small-vessel problems may damage the dopamine-producing cells that are lost in Parkinson's.
Dr. Jacobs then reviewed what is known about FGF-1, which belongs to a family of 22 related proteins. He cited animal studies in which FGF-1 protected nerve cells after a stroke and encouraged the growth of new ones. On that basis, he argued that studying FGF-1 in people with head injuries makes sense.
Looking to 2025
Mr. Montano wrote that in 2025 Zhittya expected to complete the animal testing the FDA requires before a Phase I clinical trial in brain disorders. Besides the participants with Parkinson's, a small number of people with dementia, Alzheimer's, autism and ALS were in the research studies.
The update shared three comments from participants and family members, on movement, tremor, clear thinking and walking. Mr. Montano closed by comparing the research to walking through a dark cave, with each participant's report lighting a few more steps. He acknowledged that some participants still have tremor after nine months of dosing.
This summary covers the Parkinson's research in the November 2024 update. The complete update, including the other topics it covered, is below.
Read the complete November 2024 update as published
The text of the update Zhittya sent, word for word. Pictures, charts and layout are in the PDF. Open the PDF.