First-In-Human Study of FGF-1 Delivered Into the Brain Via a Novel Intranasal Treatment for Parkinson’s Disease
LAS VEGAS, June 16, 2022 (GLOBE NEWSWIRE) -- Zhittya Genesis Medicine, Inc. (a private company) (“Zhittya”), announced that the human test subjects in its first-in-human research study for the treatment of Parkinson’s disease, at the 30 interim examination had a 50% improvement in their motor skills. Zhittya’s study utilized their human FGF-1 biological drug candidate in conjunction with a proprietary intranasal delivery device to introduce its medicine into the brain. Previous preclinical work established that twice the amount of FGF-1 could be delivered into the brain via the intranasal route versus the intravenous route. Intranasal dosing started on human test subjects on May 3, 2022 and concluded on May 30, 2022 with the patients receiving two escalating doses of intranasal FGF-1. No adverse events to date have been seen in the subjects and analysis of videos taken before and after treatment showed promising signs of motor skill improvement, according to the test subjects and the Principal Investigator supervising the trial. Additional follow-up sessions will occur at 60-days and 90-days post-treatment to assess any adverse events that may have appeared and to document any continued progress towards reversing the test subjects' Parkinson's disease.
Zhittya will be hosting a free Zoom webinar entitled: Parkinson's Disease Medical Research Study: First Look at the Data from the Intranasal Delivery of FGF-1. This webinar will broadcast at 3:00 pm (Pacific time) on Thursday, June 23, 2022. Viewers will learn more about the results of this completed research study and will be able to see data first-hand on the safety and efficacy testing collected so far. To register for the webinar please go to the company’s website: zgm.care.
Daniel Montano, CEO of Zhittya Genesis Medicine, stated: “I was there on day one when the test subjects were dosed and I was with them the final day of their dosing. From our prior clinical data on using FGF-1 to treat advanced coronary artery disease, and also from preclinical data testing FGF-1 in a primate model of Parkinson’s disease, I expected very little progress in the test subjects within the first 30 days. We believe the angiogenesis process will take 3 to 8 weeks to initiate and complete, at which point the neurogenesis process proceeds over the next 4 to 12 weeks. I was, therefore, pleasantly shocked by the improvement I witnessed in the test subjects. Please join us for our Zoom webinar on June 23 where you can view this videotaped data with your own eyes and also hear from the test subjects themselves. We are still in the early phases of discovering what is the best dose, the best duration of treatment, etc., however, I believe we are on a great start to address and resolve Parkinson’s disease issues for millions of people.”
Over the last five years, a new medical hypothesis has been proposed that Parkinson’s disease may be initiated by vascular disruption in the areas of the brain which house dopamine-producing neurons. The theory holds that, over time, micro-vascularization in the brain becomes blocked, narrowed or leaky, leading to blood flow restriction, which prevents the affected neurons from receiving proper nourishment. This disruption of a natural biological process can lead to the classical symptoms of Parkinson’s disease, including tremor and gait disturbances. Very promising improvements in motor skill testing have been seen with FGF-1 in both rodent and primate models of Parkinson’s disease. In these models, it was demonstrated that FGF-1 acted as a “disease modifying agent” by regenerating new dopamine-secreting neurons. These neurons becoming dysfunctional in Parkinson’s disease and are widely acknowledged to be the root cause of the disease.
Dr. Jack Jacobs, President and Chief Science Officer of Zhittya Genesis Medicine, stated: “Although this first study was mainly geared to test the safety of intranasally-administered FGF-1, we were pleased to see evidence of patient improvement, both on physical examinations and filming of motor skill functions, as well as testing with the standardized Parkinson’s Disease Questionnaire. The intranasal delivery of FGF-1 is incredibly simple and non-invasive and avoids the use of central catheters (picc lines) that had been originally envisioned for this study. Because of this ease of delivery, we are already designing additional research studies where intranasally-administered FGF-1 could be examined in other brain disorders including stroke recovery, vascular dementia, Alzheimer’s disease, aphasia and multiple sclerosis. We also want to expand our studies in Parkinson’s disease patients to include different dosing regimens and to study FGF-1 in patients that have deep brain stimulators (DBS) implanted or have had the devices removed. I also believe that the safety and efficacy data we collect in these relatively small human research studies will strengthen and improve the Investigational New Drug (IND) application that is on file with the US FDA. We hope to be able to start those human trials in the United States within two years”.
Again, Zhittya’s free Zoom webinar on the first-in-human results from our FGF-1 intranasal delivery study in Parkinson’s disease subjects will air on June 23, 2022, at 3 pm Pacific time (6 PM Eastern time) To register for the webinar, go to: zgm.care
About Zhittya Genesis Medicine
Zhittya Genesis Medicine, Inc. is advancing a group of drugs which trigger the human body’s natural regeneration process. Our medicine initiates a biological response in the human body referred to as “therapeutic angiogenesis,” which will only occur in diseased tissues that become ischemic due to a lack of blood flow. In those areas with insufficient blood flow, the drug stimulates the growth of new blood vessels, providing nourishment and removing metabolic waste products, thereby re-establishing normal cellular functions. In addition to the brain disorders described above, the company also has promising evidence that FGF-1 is a potential new treatment for coronary heart disease, peripheral artery disease (PAD) and diabetic foot ulcers. Currently, over 75 human diseases are known to be caused by lack of blood flow to a tissue or organ. The Company’s management has been working to advance its proprietary medicines for over 23 years and has expended in excess of $150 million USD to date in support of these efforts. To learn more, please visit: zgm.care
Daniel Montano, CEO
Zhittya Genesis Medicine, Inc.