LAS VEGAS, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Zhittya Genesis Medicine, Inc. (a private company) (“Zhittya”), announced that it is starting a “Compassionate Use Clinical Trial” for the treatment of ALS, also known as motor neuron disease or Lou Gehrig’s disease. Zhittya’s “Compassionate Use Clinical Trial” will utilize Zhittya’s proprietary FGF-1 biological drug in conjunction with a proprietary intranasal delivery device to introduce its medicine into the brain.
Over the last five years, a new medical hypothesis has been proposed that ALS may be initiated by vascular disruption in the areas of the brain which house motor 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 ALS, including muscle weakness, problems with coordination, fatigue and difficulty speaking and swallowing.
In animal models of other brain disorders, including stroke and Parkinson’s disease, FGF-1 has proven to be safe, as well as efficacious in regenerating new neurons in damaged areas of the brain. In both rodents and primates, this has led to a significant improvement in motor skills in the animals.
In the “Compassionate Use Clinical Trial” Zhittya’s biological drug will be tested in subjects with “mild” to “moderately severe” ALS. There will be no placebo dose administered in this human proof of concept study. 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 ALS 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 ALS 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 ALS 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 ALS.”
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. Our biological drug is capable of stimulating both new blood vessel growth and new motor neuron growth and has the potential to treat the root cause of ALS. I am very pleased we can offer our drug candidate via an intranasal delivery method as our animal data clearly shows that intranasally administered FGF-1 is transported into the brain via olfactory nerves and the trigeminal nerve which innervate the upper nasal cavity. I believe this is a first attempt to treat ALS with a potent growth factor administered intranasally and pray that it will change medical outcomes for ALS sufferers.”
Persons seeking information on participation in this ALS clinical trial should go to Zhittya’s website to register: https://www.zgm.care/diseases-of-the-brain/als.
For more information on Zhittya’s ALS “Compassionate Use Clinical Trial,” a Zoom webinar will be presented on February 8, 2022, at 3 pm Pacific time (6 PM Eastern time). To register for this free webinar, go to:
https://us02web.zoom.us/webinar/register/WN_uZ5HGxvxQRm5ri2GAgMQNg
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
Zhittya Contact:
Daniel Montano, CEO
Zhittya Genesis Medicine, Inc.
702-802-8373
dan@zhittyamedicine.com
