Zhittya Genesis Medicine Obtains Regulatory Approval in Mexico to Start Phase I Clinical Trials in Patients With Parkinson's Disease
LAS VEGAS, Feb. 25, 2020 /PRNewswire/ -- Zhittya Genesis Medicine, Inc. (a private company) ('Zhittya' or the 'Company'), announced that it has received official regulatory approval from COFEPRIS, the Mexican governing body which would be the country's equivalent of the U.S. Food and Drug Administration (FDA), to test its novel biological drug in subjects with Parkinson's disease. The Phase I clinical study will be conducted at the Zambrano Hospital in Monterrey, Mexico, a new, state-of-the-art medical facility.
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 or narrowed, 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.
Three ascending doses of 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 First in Man 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, "Gaining approval to conduct a Phase I clinical trial in Mexico 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 the Mexican regulatory authorities appreciated the urgent need to test new compounds for this unmet medical need and gave us swift approval to initiate our clinical studies in subjects with Parkinson's disease. Our partners in Monterrey, Mexico have also been outstanding, including the clinical research organization, Cohortias, that has an impressive track record in performing clinical studies in Latin America, as well as the neurologists at the Zambrano Hospital, who greatly contributed to improving our clinical protocol. The facility where the study will take place is a world-class operation with the highest level of medical professionalism and state-of-the-art equipment. Going forward, based on the successful approval of our Parkinson's disease clinical trial process, we also have an application to approve testing of our drug in subjects suffering from amyotrophic lateral sclerosis (ALS), which is currently in the final stages of review at COFEPRIS."
Given the accelerated rate at which the Mexican regulatory authorities acted on Zhittya's application to study its drug in Parkinson's disease patients, the Company also plans to file applications to test its biological drug in patients suffering from both chronic stroke and major depressive disorder, respectively. Zhittya believes that all of the medical applications being pursued can be classified as "unmet medical needs" with no current therapies that address the root causes of these devastating neurological disorders.
Zhittya's previously issued White Paper entitled "Parkinson's Disease: Therapeutic Angiogenesis as a Disease Modifying, Breakthrough Therapy?" is available to the public free of charge. To obtain a copy, please email firstname.lastname@example.org.
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 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 21 years and has expended in excess of $140 million USD to date in support of these efforts. To learn more, please visit zhittyaregenerativemedicine.com.
Daniel C. Montano, CEO
Zhittya Genesis Medicine, Inc.
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SOURCE Zhittya Genesis Medicine