LAS VEGAS—Zhittya Genesis Medicine, Inc. announced today that the company plans to initiate clinical trials to test a medical hypothesis that has been advanced over the last five years: Parkinson’s disease may be caused by vascular disruption in the areas of the brain which house dopamine-producing neurons, the neurons that become dysfunctional in patients suffering from this disorder.
The hypothesis: micro-vascularization in the relevant area of the brain is blocked or narrowed, which restricts the flow of blood needed to nourish these neurons and results in the classical symptoms of Parkinson’s disease. Just as blockage of coronary arteries can lead to angina and heart attacks, that same process is now thought to underlie the development of Parkinson’s disease.
Zhittya will give a Zoom Webinar on its potential therapy to reverse the progression of Parkinson’s disease on Tuesday September 29 at 8:00 AM Pacific time (11:00 AM Eastern). The webinar is free of charge. To register, go to zgm-parkinsons.com.
An imaging technology known as functional MRI, which can measure regional blood flow in the brain, will also be discussed in the webinar. Published diagnostic imaging data has shown diminished blood flow in the area of the brain where the dopamine-producing neurons reside in the substantia nigra region, with Parkinson’s disease patients showing only 50% of the blood flow you would expect to see in a healthy younger person.
“I believe we are truly on to something here,” stated Daniel C. Montano, CEO of Zhittya Genesis Medicine. “Over the last three years, we have continually uncovered data which enhances our belief that therapeutic angiogenesis might be a viable breakthrough treatment for Parkinson’s disease. If, as we believe, Parkinson’s disease is caused by micro-vascular disruption in the brain, we hope our molecule can do in the brain what it has already demonstrated it can do in the US FDA-cleared heart trial: namely, grow new blood vessels.”
Zhittya is advancing upon what it believes could be a disease modifying agent that has the potential to slow down — and possibly even reverse — the inexorable decline seen in patients who suffer from this devastating disease. Zhittya is developing a biological drug which has demonstrated in previous U.S. Food and Drug Administration (FDA)-authorized clinical trials that it can trigger therapeutic angiogenesis. In animal studies, monkeys that were given experimental Parkinson’s disease and treated with Zhittya’s biological drug experienced a halt in the decline of their motor skills, and improved almost back to the point of their normal movement abilities.
Zhittya has been given permission to start a Phase 1 proof of concept clinical trial in Mexico, where three escalating doses of its angiogenesis drug will be studied in patients with Parkinson’s. A similar study is under review by regulatory authorities in Estonia. Zhittya has also filed an Investigational New Drug application with the FDA to advance its drug into a Phase I clinical trial in subjects with Parkinson’s disease.
“Millions of people around the world suffer from Parkinson’s disease. We believe we may have a breakthrough therapy for this disease, which is why we will be spending many millions of dollars to prove if we are right or wrong. In the monkey experiments that were done, our drug demonstrated a genuine disease modifying effect, by regenerating new dopamine neurons in the brain, and it is this activity that we believe led to the restoration of the animal’s motor skills,” pointed out Dr. Jack Jacobs, president of Zhittya Genesis Medicine. “We do not know if, in human clinical trials, the medical outcome will be the same, but what I do know is that we have to find out and we owe this to the millions of sufferers of this horrific disease.”
Zhittya has also prepared a white paper entitled “Parkinson’s Disease: Therapeutic Angiogenesis as a Disease Modifying, Breakthrough Therapy?” which is available free of charge. To read the paper, email dan@zhittyamedicine.com.
