BOCA RATON, FL--(NewMediaWire - May 4, 2017) - Protext Mobility,
Inc. (OTC PINK: TXTM) ("Protext" or "the Company"), a biotech
company engaged in the development of pharmaceutical
applications with highly bioavailable Phytofare® extracts,
announced today that it has signed an agreement with
the Centre International de Developpment
Pharmaceutique (CIDP) to conduct a human clinical trial
with its product Phytofare® Catechin Complex, in the country of
Mauritius.
The study is titled "Clinical Trial on Humans to determine the
efficacy of Phytofare® for lowering HbA1C levels in II Diabetes
patients." When glucose builds up in a person's blood, it
binds to the hemoglobin in red blood cells. The HbA1C test measures
how much glucose is bound over a 2-3 month period to determine
average plasma glucose concentration. The objective of the study is
to determine the efficacy of Phytofare® Catechin Complex for
improving the levels of hypoglycemia in people with diabetes as
emphasized in the American Diabetes Association's new 2017
Standards of Medical Care in Diabetes. The Company expects to
begin phase-one with a bioavailability study this month with CIC
Cynologies to confirm the human clinical study dosage of Phytofare®
Catechin Complex. Results are anticipated for release in June; then
followed by the implementation of the Type-II diabetes human
clinical trial in the second half of 2017, to be undertaken by
CIDP.
Roger Baylis-Duffield, Chief Executive Officer of Protext,
commented, "Management recently held extensive meetings with CIDP
in Mauritius and were duly impressed with the medical
infrastructure and levels of professionalism. Having a
qualified team in Mauritius to oversee and manage the human
clinical trial is a tremendous asset as the study findings will be
subjected to a vigorous peer review. Based on the outcome of
the clinical studies, the company intends to submit its findings to
the United States FDA under their Botanical Drug classification to
obtain clearance to market Phytofare® specifically for treating
Type II diabetes. Botanical drugs are subject to fewer
requirements by the FDA and can obtain clearance much faster and
with significantly less cost. The human clinical trial is an
important milestone, and next step, for the Company as obtaining a
diabetes claim would enable the company to; enter a market where
12% of global health expenditure is spent on diabetes ($673
billion), and globally license the product to benefit and to
improve the lives of people affected by Type II diabetes throughout
the world, including to more than 29 million Americans suffering
from this disease. Until we obtain an FDA clearance specific
to diabetes, we intend to commence selling the product worldwide
using "structure function claims" about the general benefits of
Phytofare® in regulating glucose levels."
Mrs. Vandana Mungroo, Head of clinical operations CIDP, who will
oversee the human clinical trial in Mauritius, added, "We're
excited to work with Protext on a project that is so critical to
the health of Mauritius, where an estimated 25% of the population
suffers from Type II Diabetes. Having a complex of active
antioxidants available to help regulate glucose levels would be a
significant benefit to developing countries where the populations
are hardest hit. Multiple third-party studies indicate that
green tea catechins show potential for regulating glucose levels
however; human clinical research in this field has been hampered
due to poor bioavailability and high dosage. We now believe
that the higher bioavailability of Phytofare® may overcome these
challenges and lead to an all-natural inhibitive and preventative
treatment of the disease."
Phytofare® Catechin Complex is a highly-bioavailable extract
produced from live green tea leaves. The unique manufacturing
process of Phytofare® yields an end product that contains all eight
catechins (antioxidants) found in green tea. Human clinical
studies have shown that more than ten times Phytofare® catechins
are transferred into the blood plasma over generic catechin
extracts, where they remain at therapeutic levels for more than 24
hours.
CIDP is a private and independent CRO carrying out high
performance research and clinical activities for pharmaceutical,
medical device, nutrition and cosmetic industries. With over 12
years of experience in the clinical research, CIDP has now a strong
foothold of each continent with centers located in Brazil, India,
Mauritius, Romania and Singapore. The services provided are
segmented into five main areas of expertise:
Research & Innovation,
Preclinical (Invitro) Clinical, Biostatistics
and Data and Regulatory Affairs. CIDP has also developed an
independent Global Quality Assurance department which monitors
their studies worldwide. All subsidiaries are ISO 9001
certified. For additional information visit www.cidp-cro.com.
We encourage our investors and shareholders to connect and
engage with us through social media. You can find us on the
following:
YouTube: http://bit.ly/ProtextYouTube
Twitter: https://twitter.com/protxtm
Instagram: https://www.instagram.com/protextm/
About Protext Mobility, Inc.
Protext Mobility operates two wholly owned subsidiaries; Plandai
Biotechnology South Africa (Pty) Ltd. and Cannabis Biosciences,
Inc. The Company is engaged in the research, clinical testing
and commercialization of highly bioavailable botanical products --
all natural ingredients formulated for pharmaceutical applications
and produced under pharma-grade conditions.
Through its wholly owned subsidiary Plandai Biotechnology SA,
the Company has the exclusive worldwide license to develop
Phytofare® extracts from live plant materials including Phytofare®
catechin complex, a highly bioavailable, and clinically proven
antioxidant complex produced from live green tea
leaves. Phytofare® can deliver a therapeutic level of
catechins, which function as powerful antioxidants, to the system
where they remain active for over 24 hours. Targeted applications
for the Company's products include arthritis, inflammation,
anti-viral, and diabetes-related metabolic syndromes.
Please visit http://www.protextm.co for further
information.
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