Protext Pharma, Inc. (publicly traded under “TXTM”), operates two wholly owned subsidiaries: Plandai Biotechnology South Africa (SA) and Cannabis Biosciences, Inc. Through these companies, we are engaged in the research and clinical testing of “bioceutical” products—all natural ingredients formulated for pharmaceutical applications and processed under pharma-grade conditions.
Plandai Biotechnology SA has the exclusive worldwide license to develop pharmaceutical applications and products using Phytofare® Catechin Complex, which was developed by Plandaí Biotechnology, Inc. Phytofare® is a highly bioavailable extract produced from live green tea leaves. Human clinical trials have shown Phytofare® to have 12 times greater bioavailability over generic catechin extracts. What this means is that Phytofare® can deliver a therapeutic level of catechins, which function as powerful antioxidants, to the system where they remain active for over 24 hours. Plandaí grows green tea on its 7,500 acre estate in South Africa, where it also produces the proprietary Phytofare® catechin extract. This vertical structure gives the Company a continuity of supply as well as quality control throughout the entire process. Targeted applications for the Company's products include arthritis, inflammation, anti-viral, and diabetes-related metabolic syndromes.
Cannabis Biosciences was formed and incorporated in 2013 to legally develop non-psychoactive medicines from live cannabis plant. Using our proprietary processing and extraction technology platform, the company intends to commence investigations in conjunction with independent researchers to develop and validate a full-profile cannabis extract, one that contains both CBD and the precursor acid form of THC (THC-A and THC-B) found in live cannabis plant. The expectation is that the resultant extract will have similar, superior bioavailability of other Phytofare® extracts with the added benefit of being non-psychoactive. Several third- party investigations have shown that the precursor acid forms THC-A and THC-B in live cannabis leaf are inherently non-psychoactive and that the process of drying and heating the leaf metabolizes these acids into THC, a chemical that triggers the euphoria sought after by recreational users. The Company’s investigations will show that the Cannabis Biosciences extraction process, which will use live leaf and low temperatures to extract the phyto-chemicals, leaves the acid forms of THC intact, resulting in a non-psychoactive extract with full medicinal potential. The Company is actively pursuing government licenses and permits, which are anticipated to be issued in Q4, 2017, that will allow it to use its proprietary processing and extraction technology to commence investigations and produce a full-profile cannabis extract.
Metabolic syndrome is a cluster of conditions — increased blood pressure, a high blood sugar level, excess body fat around the waist and abnormal cholesterol levels — that occur together, increasing your risk of heart disease, stroke and diabetes. Diabetes Type 2 is a long term metabolic disorder that is characterized by high blood sugar, insulin resistance, and relative lack of insulin. Long-term complications from high blood sugar include heart disease, stroke, diabetic retinopathy which can result in blindness, kidney failure, and poor blood flow in the limbs which may lead to amputations. Levels of type 2 Diabetes have increased markedly since 1960 in parallel with obesity, and as of 2013 there were approximately 368 million people diagnosed with the disease compared to around 30 million in 1985.
In looking for a natural solution, epidemiological evidence indicates that populations with a high intake of green tea catechins benefit in terms of body weight, body fat, the balance of insulin blood glucose, and cardiovascular health. This is particularly true considering the strong research data from in vitro and animal studies where actions from green tea catechins have shown decreased carbohydrate absorption, decrease hepatic glucose production (the inability of insulin to suppress hepatic glucose production is a key defect found in type 2 diabetes) and increased insulin sensitivity (the relationship between how much insulin needs to be produced in order to deposit a certain amount of glucose).
However, transferring the scientific findings from in vitro and animal studies to humans has always been met with metabolism and degradation issues as well as poor bioavailability. Any proposed catechin therapy would require high dosage of catechins that could induce toxicity and side effects.
Phytofare® catechin complex is a highly bioavailable complex of all 8 catechins found in green tea that have been clinically researched to efficiently transfer the antioxidants into the blood plasma, where they remain for more than 24 hours. Furthermore, the daily dosage has been established at 12 times less than generic green tea, thereby delivering an active antibiotic without toxicity or side effect issues.
To clinically prove these antidiabetic benefits in humans, Protext will undertake a double- blind human clinical trial, with the objective to commercialize an affordable solution to a multibillion dollar global market opportunity for the prevention and containment of metabolic syndrome causes.
The plant Cannabis sativa produces over 421 chemical compounds including 80 terpeno-phenol compounds (phytocannabinoids) that have not been detected in any other plant. Currently, commercial attention has been focused on producing extracts of ∆9- tetrahydrocannabinol (∆9- THC) which is the most psychotropic component and rapidly metabolizes in the body to a number of oxygenated products, but specifically binds to the G-protein-coupled CB1and CB2 neuron receptors, and in isolating the non-psychoactive CBD (hemp) compound.
Our strategy is to improve the efficacy by delivering a complex of highly bioavailable non-psychoactive cannabinoids and polyphenols. We will eliminate the psychotropic side effects of ∆9- tetrahydrocannabinol by retaining it in its natural form: ∆9- tetrahydrocannabinol acid (∆9-THCA and (∆9-THCB), cannabidiolic acid (CBDA) and ∆9 tetrahydrocannabivarin (∆9-THCV). Research shows that these compounds, together with cannabidiol (CBD), deliver several safe, positive pharmacological effects in treating inflammation, diabetes and cancers without the unwanted psychosis of THC.
Cannabinoids have also been shown to exert neuroprotective actions relevant in the treatment and prevention and apoptotic signalling of neuro-degenerative diseases including Alzheimer’s, Parkinson’s and Huntington’s.
Based on all the scientific evidence, the company intends to produce a complex of the entire plant phytonutrients, including cannabinoids, cannabinoid acids and polyphenols, delivered in sub-micron and nano- lipophilic particles with high human isomeric identity. Based on published science, Phytofare® cannabinoid complex should not exhibit any psychoactive activity because the conditions for the formation of THC from THC-A and THC-B acids will not be introduced, and where it is already proven that the acids in their natural state are not psychoactive. (American Herbal Pharmacopoeia Cannabis Inflorescence 2013 Page 34)
The business model is to produce a Phytofare® dietary supplement containing a complex of non-psychoactive cannabinoids entrapped in liposome and delivered for oral administration. Following the initial profiling, bioavailability, dosage levels and the absence of psycho-activity will be established. We will then seek declassification of the extract from the Government of South Africa from a code 6-controlled substance to a code 4 and thereby allowing the Company global reach for licensing and sale of cannabis product as on over the counter prescribed medicine.Chairman & CEO: Roger Baylis-Duffield
Mr. Duffield has a significant background in the development and management of start-ups, private and public companies, in the United States, Europe and South Africa. Currently, Mr. Duffield serves as CEO of Protext Mobility as well as Chairman of Plandai Biotechnology Inc., a USA public company with operations in South Africa. He also serves as the non-executive chairman of the Dunn Roman group of companies. In 2002, Mr. Duffield cofounded the Plandai group of companies, which is now comprised of considerable interests in biopharmaceuticals in South Africa, including the 7500 acre Senteeko green tea estate. He has an extensive background with published scientific research and development of Plandai sciences and bioavailable botanical extracts through the actions of cavitation and sonoluminescence relating with live plant materials and emulsions. The Plandai science platform involves contributions from numerous academic institutions and research laboratories.
Mr. Duffield was awarded in 1997 an Honorary Nuclear Doctorate by the Russian Academy of Natural Sciences and a further Honorary Doctorate in Material Sciences by the European Natural Sciences. In 2001 the Foundation for International Services, California granted recognition of a BSc qualification in Chemical Engineering. During the period 1990 through 2002 Mr. Duffield both founded and managed two USA public companies involved with new sciences relating to hydrocarbons, emulsions and fuel cells supported through powder metallurgy. Extensive published research has been undertaken with numerous academic institutions through the world, including USA, Europe, Russia, Siberia and South Africa. Mr. Duffield also has an extensive background in the farming of sub-tropical fruits and green tea when he owned and operated farms in South Africa.