February 2024 update

In short

Zhittya presented its FGF-1 research at a cardiovascular conference in Dubai. Work continued on brain scanning studies designed to measure blood flow, and a new production batch of FGF-1 was completed for the Parkinson's studies.

The February update began with a new one-minute animation on Zhittya's video channel. It showed the team's current theory of how FGF-1 might act in the brain of a person with Parkinson's.

A conference in Dubai

In mid-February, members of the team attended a large cardiovascular medicine conference in Dubai, which the update said drew more than 400 doctors. Dr. Jack Jacobs gave three talks. One made the case that Parkinson's is a disorder of the blood vessels and asked whether growing new vessels could change its course.

According to the update, heart specialists readily accepted the idea that reduced blood flow in the brain weakens brain function, and many asked about Parkinson's on behalf of family and friends. People with Parkinson's traveled from Bangladesh and India to hear the talks.

Plans for brain scanning

The team was searching its records for people who might qualify for brain blood-flow scans at Washington University in St. Louis. It expected to handle two or three scan participants a month, with a goal of 16 people with Parkinson's in the first phase.

Each person would be scanned before receiving FGF-1 and again six months after dosing, with a third scan at 12 months under consideration. Under the current plan, called Protocol 17, participants are dosed again every six months over a 12-month period. The update said many participants had reported changes in short-term and long-term memory between months 6 and 12, and the team wanted to see whether blood flow kept changing during that window.

CEO Dan Montano wrote that if scans showed more blood flow in an area that had too little before dosing, the team would have a logical reason to believe FGF-1 was acting on poor blood flow in the brain. He described that as evidence still to be gathered.

Making more FGF-1

The update was sent later than usual because Dr. Jacobs and Vika Montano had been at the company's laboratory in Reno, Nevada, inspecting the latest FGF-1 production run. Zhittya was using FGF-1 faster than expected, both in the human research studies and in animal toxicity studies meant to support future applications to the U.S. Food and Drug Administration (FDA). Mr. Montano believed production in 2024 needed to be about 30 times what it was in 2023.

He also gave his personal hope that the FDA might clear a Phase I clinical trial in Parkinson's in 2025.

How FGF-1 spreads through the brain

Dr. Jacobs explained that FGF-1 given as a nasal spray reaches the cerebrospinal fluid, the clear fluid that bathes the whole brain. Collaborators at the University of Minnesota attached a radioactive label to FGF-1, gave it to rats through the nose, and then measured where it went. It was found throughout the brain, including the substantia nigra, the region involved in Parkinson's.

He gave reasons the brain takes up so much FGF-1. The adult brain has about 100 billion nerve cells, and each carries thousands of receptors for FGF-1 on its surface. Support cells and the brain's blood vessels, which he said run for an estimated 400 miles, carry these receptors too.

From this, Dr. Jacobs concluded that a single round of nasal dosing was not enough. Because Parkinson's is a progressive condition, the team's current view was that dosing should be repeated every six months. He called the work "a new medical frontier" and expected the dosing plan to change as the team learned more.

The update shared five comments from participants and caregivers. They covered energy, voice, walking, thinking and sleep, along with problems that had not improved, such as balance and freezing. The rest of the update covered other research areas and an upcoming conference.

This summary covers the Parkinson's research in the February 2024 update. The complete update, including the other topics it covered, is below.