LAS VEGAS, Jan. 12, 2022 (GLOBE NEWSWIRE) — Zhittya Genesis Medicine, Inc. (a private company) (“Zhittya”), announced that it is starting a “Compassionate Use Clinical Trial” for treatment of Parkinson’s disease. Zhittya’s “Compassionate Use Clinical Trial” will utilize Zhittya’s proprietary FGF-1 biological drug in conjunction with a proprietary intranasal device to introduce its medicine into the brain via the nasal cavity.
Zhittya is currently advancing what it believes could be a “disease modifying agent,” as its drug has previously demonstrated, through preclinical studies, the ability to potentially halt and even reverse the inexorable decline in motor symptoms seen in patients with Parkinson’s disease.
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.
In the “Compassionate Use Clinical Trial” Zhittya’s biological drug will be tested in subjects with “mild” to “moderately severe” Parkinson’s disease. There will be no placebo dose administered in this human proof of concept study. In preclinical studies involving rodents and primates, Zhittya’s biological growth factor has demonstrated the ability to stop the decline and dramatically enhance the motor skills of the animals tested. Importantly, the regeneration of newly formed dopamine-producing neurons was also seen in the treated animals, meaning that Zhittya’s drug appears to be affecting the root cause of Parkinson’s disease, namely the loss of these specialized neurons. While the primary purpose of this first clinical trial is to test for the safety of the drug, readouts on possible improvements in the patient’s Parkinson disease symptoms will also be studied.
Daniel C. Montano, Zhittya’s CEO, commented, “Starting this ‘Compassionate Use Clinical Trial’ represents another major step for us and our partners in learning whether our medicine is safe in humans and, if so, whether we can modify the progression of Parkinson’s disease to enhance outcomes for those afflicted by this terrible disease. Over the last two decades, we’ve dedicated tremendous resources to reach the point where we can now officially test our hypothesis that Parkinson’s disease is a disorder caused by issues of micro-vascularization within the brain. We are entering a true proof of concept trial that will hopefully indicate we can treat and possibly even reverse the effects of Parkinson’s disease. We’ve seen remarkable outcomes in our preclinical animal studies, and we are confident that we’ll see successful results in humans as well.”
Dr. Jack Jacobs, President and Chief Science Officer of Zhittya Genesis Medicine, added, “We are pleased that we are able to start this ‘Compassionate Use Clinical Trial’ as we believe there is an urgent need to test new compounds for this unmet medical need treating the cause of Parkinson’s Disease. Going forward we hope to seek successful approval of our Parkinson’s disease treatment.”
Persons seeking information on participation in this Parkinson’s disease clinical trial should go to Zhittya’s website to register: https://www.zgm.care/diseases-of-the-brain/parkinsons-disease. For more information on Zhittya’s “Compassionate Use Clinical Trial”, a Zoom webinar will be presented on February 1, 2022, at 3 pm Pacific time (6 PM Eastern time) for Parkinson’s disease. To register for the Free webinar, go to:
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. Heart disease, stroke, peripheral artery disease (PAD) and diabetic foot ulcers are just some of the disorders the drugs can possibly treat. 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 $140 million USD to date in support of these efforts. To learn more, please visit: ZGM.care
Daniel Montano, CEO
Zhittya Genesis Medicine, Inc.