BOCA RATON, FL--(Marketwired - May 4, 2017) - Protext Mobility, Inc. (
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 .
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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.
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