In short
Zhittya began working toward collaborations with medical imaging centers in the United States and Italy. The aim was to measure whether blood flow in the brain changes after FGF-1 dosing in people with Parkinson's.
The January update opened the year with a plan to add brain imaging to the Parkinson's research. Zhittya's working idea is that many brain conditions involve too little blood reaching specific parts of the brain, and that FGF-1 may prompt new blood vessels to grow there. The team wanted scans taken before and after dosing to test that idea directly.
The update said more than 120 people had been dosed with FGF-1 in the research studies so far, including people with Parkinson's and several other neurological conditions. Participants had reported changes in movement, memory, thinking and balance. Three participant comments on those topics were shared.
Planning the brain scans
Dr. Jack Jacobs had spent more than a year looking for imaging centers that could measure blood flow in the brain. He identified two research groups, one at Washington University in St. Louis and one at Tor Vergata Hospital at the University of Rome. The update said the team believed it had clearance from both to scan people with Parkinson's before and after they received FGF-1.
The plan was a first scan before dosing and a repeat scan six months later, with possible further scans at 12 and 24 months. Scanning was expected to begin in March 2024, with only two to four volunteers at first. Dr. Jacobs wrote that the MRI scan is non-invasive and lasts about an hour and a half.
CEO Dan Montano was open that the answer was not yet known. "What we do not know is if FGF-1 is fixing that problem," he wrote. He added that people reporting better memory might be improving because of new blood flow or for some unrelated reason, and that imaging was a step toward real evidence.
What the scans can show
Dr. Jacobs explained that this kind of MRI can measure blood flow across the whole brain or in one small region, such as the substantia nigra, the area affected in Parkinson's. He showed published examples from other researchers, including images comparing blood flow in a healthy person and a person with Parkinson's.
The team's hypothesis was that FGF-1 leads to better blood flow and may wake nerve cells that have gone dormant for lack of blood. Growth of new blood vessels is called angiogenesis, and Dr. Jacobs wrote that published reports link it to the formation of new nerve cells. He pointed to an earlier study in monkeys, done by researchers outside Zhittya, in which animals with an experimental form of Parkinson's were given FGF-1 and developed new dopamine-producing nerve cells over seven months.
Leaky blood vessels
Dr. Jacobs also described a problem called endothelial cell dysfunction. Every blood vessel is lined with a single layer of endothelial cells. When that lining is damaged, vessels can leak, so less blood reaches the tissue and substances that should stay in the blood escape into it.
He wrote that researchers have linked this problem to several brain disorders. As an example, he described a published mouse study of multiple sclerosis in which the damaged vessel lining looked orderly again after 30 days of FGF-1. That was an animal result, not a result in people.
How long to keep dosing
The update explained that the studies began with a single round of FGF-1, called Protocol 1, and had reached Protocol 17, which repeats dosing at six months and possibly at 12 and 18 months. The team did not yet know how often or for how long dosing should continue. Mr. Montano wrote that Zhittya intended to follow participants for the long term to learn what happens over many years.
Dr. Jacobs was also due to speak in Dubai in February, including a talk on Parkinson's as a disorder of the blood vessels. The rest of the January update covered other research areas and company matters.
This summary covers the Parkinson's research in the January 2024 update. The complete update, including the other topics it covered, is below.
Read the complete January 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.