PharmaCyte Biotech Inc (PMCB)

[bulldurham]

Just to remind Nuvilex shareholders... we should never think that the company is sitting stagnant and not doing what they set out to do...with all the work being done in the background...behind the scenes...that we know nothing about YET...here is an older article that outlines where the company was going with Diabetes that was written in March 18, 2013...http://www.stockmarketmediagroup.com/nuvilex-inc-diabetes-studies-could-eliminate-need-for-daily-insulin-requirements/

Now we can fast forward to the 10K that just came out and compare the 10K and Waggoner's words... to the article...

Diabetes Studies

Diabetes is a major problem throughout the world. Approximately 382 million cases have been diagnosed world-wide. It is estimated that this number will rise to 592 million by 2035. Approximately 175 million have diabetes and do not know it. Diabetes caused 5.1 million deaths in 2013; every six seconds a person dies from the complications caused by diabetes. Treatments for diabetes and its complications caused at least $580 billion in health care expenditure in 2013. In 2013, more than 21 million live births were affected by diabetes during pregnancy.

Diabetes is caused by insufficient availability of, or resistance to, the hormone insulin. Insulin is produced by the islet cells of the pancreas. Its function is to assist in the transport of glucose (sugar) in the blood to the inside of most types of cells in the body where it is used as a source of energy for those cells. In Type 1 diabetes, which usually begins at a young age, the islet cells of the pancreas have been destroyed, usually by an autoimmune reaction. Type 1 diabetics require daily insulin administration through injection or through the use of an insulin pump. Type 2 diabetes, which is more prevalent than Type 1, can be controlled by diet and exercise in its early stages. As time goes by, it may be necessary to use antidiabetic drugs to control the diabetes. However, over time these too may lose their effectiveness. Thus, even Type 2 diabetics may eventually need insulin administration.

Dr. Günzburg and Dr. Salmons are also fulfilling a major role in the development of the Company’s treatment for diabetes that is based on the Cell-in-a-Box® technology. Dr. Günzburg and Dr. Salmons have introduced the Company to the participants and potential participants in the Company’s diabetes program in an attempt to develop a medical breakthrough in how diabetes will be treated in the future throughout the world. Researchers at a major university in Australia have developed insulin-producing cells from a human hepatocellular carcinoma cell line. These cells have been exhaustively tested in vitro and found to be capable of producing insulin in direct correlation to the amount of glucose in their surroundings. Negotiations are underway between Nuvilex and that university for an exclusive, worldwide license to use these insulin-producing cells in combination with the Cell-in-a-Box® technology in developing a product for the treatment of insulin-dependent diabetes. No assurance can be made that such a license will be entered into, however. Further, the license is contingent on the insulin-producing cells passing a tumorigenicity test that will be conducted by the University of Veterinary Medicine Vienna (“UVMV”) where Dr. Günzburg is a professor in the Department of Virology. He will coordinate all of the work for the Company being done by UVMV. This test will show whether or not these particular cells have the capacity to form tumors because they were developed from a liver cancer cell line. If they do not, then preclinical animal studies will first be done with these cells. If the studies are successful, they will lead to clinical trials. In the event that the cells are tumorigenic, then it will be necessary to develop another insulin-producing cell line for encapsulation.

Since Dr. Günzburg and Dr. Salmons have previously worked with these insulin-producing cells and have them in frozen storage at Austrianova Singapore, the Australian university was approached to obtain permission for these stored cells to be used for the tumorigenicity testing. Written authorization from the Australian university has been obtained for the use of these insulin-producing cells for this testing. Since the tumorigenicity of the cells will be determined at the UVMV, the terms and conditions of a Collaborative Research Agreement (“CRA”) between the Company and the UVMV has been agreed to between the parties. The CRA is in the final stages of drafting. Once finalized and signed, the tumorigenicity studies will commence. However, no assurance can be made that the CRA will be finalized between the parties.

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In the majority of diabetes animal models used by others, the diabetic condition is induced by employing drugs to destroy the normal insulin-producing capability of the pancreas in those animals. The University of Munich (“UOM”) in Germany operates a €5-million animal farm that houses animals for research purposes. Scientists at the UOM have developed unique transgenic mouse and pig models of diabetes. Through the use of gene transfer technologies, mice and pigs that are diabetic at birth have been developed. These model systems more closely mimic Type 1 diabetes in humans than any other model systems available world-wide. Through introductions by Dr. Günzburg and Dr. Salmons, the investigators at UOM have agreed to join the Nuvilex team in its efforts to develop a treatment for diabetes based on the Cell-in-a-Box® technology. The Company plans to enter into a research agreement with the UOM in the near term. However, no assurance can be made that such an agreement will be entered into between the Company and the UOM.

The Company is in the process of developing a diabetes consortium consisting of major universities, renowned scientists and physicians and CNS (“Diabetes Consortium”). Executive officers of Nuvilex and the institutions identified above have already explored the possibility of joining the Diabetes Consortium. These institutions will be part of the Diabetes Consortium, as will Dr. Gunzburg and Dr. Salmons through their consulting company, Vin-de-Bona Trading Co. Pte Ltd (“Vin-de-Bona”). The consensus among individuals that could be involved is that the formation of the Diabetes Consortium would be beneficial to all parties and may be a way of optimizing the development of the Company’s treatment for diabetes given the free flow of ideas and communication that would occur within such a consortium. Dr. Löhr has a great deal of interest and expertise in treating diabetes. Because of this, he will be assisting the Company in the development of a treatment for diabetes that will employ the Cell-in-a-Box® cellulose-based live cell encapsulation technology. If and when the Diabetes Consortium finally reaches fruition, Dr. Löhr is also expected to play a prominent role in it.

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