Parkinson's Disease Phase I Clinical Trial Approved for Zhittya Genesis Medicine Inc
26 February 2020 - 2:00AM
InvestorsHub NewsWire
Zhittya Genesis Medicine Obtains
Regulatory Approval in Mexico
to Start Phase I
Clinical
Trials
in Patients with
Parkinson's Disease
Las Vegas, NV
-- February
25, 2020 -- InvestorsHub NewsWire
-- 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 dan@zhittyamedicine.com.
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.
Zhittya
Contact:
Daniel C.
Montano, CEO
Zhittya Genesis Medicine,
Inc.
702-790-9980
dan@zhittyamedicine.com