December 2024 update

In short

Participants continued to send reports about movement and thinking. The team was waiting on follow-up MRI scans at Washington University in St. Louis to measure blood flow in the brain.

The December update centered on follow-up brain scans and a look back at the year in the Parkinson's research.

Follow-up scans in St. Louis

CEO Dan Montano and Vika Montano had just returned from the dosing of the 31st group of participants. Before that, they made two visits to the Washington University School of Medicine in St. Louis for functional MRI scans of two participants. These scans measure blood flow in the brain. The team hoped the method would be sensitive enough to detect any change in blood flow linked to FGF-1.

For one of the two, this was the six-month follow-up to a scan taken before he began dosing. The comparison images had not yet arrived. Mr. Montano hoped to have them soon.

He described meeting this participant at the first scan and again six months later, and wrote that the difference in his walking, balance, voice and memory was striking. The participant's wife gave her own six-month account in the comments section. She described a stretch of several weeks of clear improvement, followed by a return of some symptoms, along with some lasting changes.

Mr. Montano stressed that the main question had not been answered. "The scientific question still remains open: why is he doing better?" he wrote.

The team's belief is that FGF-1 prompted new blood vessels to grow, a process called angiogenesis, and that fresh blood was reaching undernourished cells. The scan images were meant to test that belief. More scans were under way.

The year in Parkinson's research

The update said more than 200 people with Parkinson's had now received FGF-1 in the research studies. According to Mr. Montano, most had shown clear improvement and others more modest improvement.

The team's main lesson from the year was about dosing. The first participants, two and a half years earlier, received Protocol 1, a single round of FGF-1 with no repeat doses. Current participants receive Protocol 17, which the update said gives more than 16 times as much FGF-1 over two years. Mr. Montano wrote that more FGF-1 over a longer period had led to better outcomes than the original plan.

The dose and length of dosing were being raised slowly. He expected the team might move to higher dosing levels in 2025.

What was still unknown

Mr. Montano wrote that he did not know when the team would be able to say it had found the best protocol for Parkinson's, which it needs before moving into the clinical trials required for FDA approval. He thought the studies could include 400 participants with Parkinson's by the end of 2025. He doubted that this alone would satisfy the FDA.

Upcoming talks

Dr. Jack Jacobs was named to receive a "Man of the Year" award from the Nevada Bio organization at its annual dinner in Las Vegas on April 2, 2025, where he would give a short talk on the Parkinson's research. He was also invited to speak at an autism conference in Texas in late May.

The update shared four comments from participants and family members. They covered alertness, appetite, walking, tremor and hand use. One participant wrote that she had no big improvements to report. The rest of the update covered policy opinions, other research areas and company matters, which are not carried here.

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