August 2024 update

In short

Another group of participants with Parkinson's was dosed, bringing the total to about 180 people. The team discussed plans to refine dosing protocols.

The August update gave a progress report as the 27th group of participants prepared to begin dosing on August 18. More of the earliest participants were reaching two years in the research studies.

Zhittya had now dosed 180 people with Parkinson's. The update said one participant reported a mild headache after dosing. About a year earlier the team had moved to Protocol 17, which continues dosing over a longer period. CEO Dan Montano wrote that he believed continued dosing was bringing greater improvement.

He was clear that results differed from person to person. Some participants had reported large improvements in motor skills and mental skills, and others less.

Still looking for the right dose

Mr. Montano wrote that the team was still trying to work out which dosing gives the best outcome. In earlier research in other parts of the body, he said, one round of FGF-1 was followed by new blood vessel growth within weeks. The brain was proving much slower. He compared dosing in the brain to "a water hose running into the Arizona desert": good things were happening, but very slowly.

The team was studying its participants and thinking about how to help them improve more, and more quickly. Mr. Montano wrote that two years of human data suggested Zhittya "could be on the right pathway." His hope was that, once the best dose was found, the company could begin an FDA Phase I clinical trial in the United States.

He also wrote that attitudes were shifting. Two years earlier, he said, neurologists dismissed the work. Now some had seen changes in their own patients and were watching with an open mind. Hospitals in Saudi Arabia, Dubai and Kuwait had invited the team to present its data.

A talk in Kuwait

Dr. Jack Jacobs was scheduled to speak in early October at Dar Al Shifa Hospital, one of the largest private hospitals in Kuwait. His subject was new approaches to Parkinson's, and several hundred guests were expected. It would be his third trip to the Gulf region in two years.

Open questions

In his closing section, Mr. Montano wrote that "after two years, the brain is still a mystery." He listed questions the team could not yet answer. Why did one participant's motor skills improve far more than another's after six months? Why did memory sometimes change suddenly, a year after dosing?

He also asked why changes seemed to come in waves, up and then down, and what dose is best and for how long.

He wrote that participants ask every week for more FGF-1 so they can improve faster, and that the team says no. The research has to move forward step by step, with everyone dosed the same way, so the team can learn what works and what does not. Some participants who once needed a walker were now walking better, he wrote, "but not normal yet." Full recovery had not been achieved.

The update shared five comments from participants and family members. They covered voice, balance, energy, falls, thinking and a neurologist's examination. The rest of the update covered other research areas and company matters.

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