PharmaCyte Biotech Inc (PMCB)

[Peacefulwendy]

An absolutely false statement. Here is some of what has been accomplished by Ken Waggoner since he has come board.

Q: Can you describe some of the major milestones you’ve been able to accomplish since coming on board?

KENNETH: First and foremost, PharmaCyte Biotech has been completely transformed from a nutraceutical company into a pure biotechnology company. We are no longer in the nutraceutical business. Some of the other major milestones include the following:

The financial position of PharmaCyte Biotech has become the strongest in the Company’s history. We are virtually debt-free and have access to all of the necessary capital required to meet both our short-term and long-term financial commitments.

We are well underway in completing the necessary steps to commence three clinical trials using our Cell-in-a-Box® technology. The first will be a Phase 2b clinical trial of our pancreatic cancer treatment. Our pancreatic cancer treatment will be compared “head-to-head” with the current best available treatment for the disease. This treatment is the combination of gemcitabine with Celgene’s drug Abraxane®. We expect to begin this clinical trial in the third quarter of 2015.

We are also underway in completing preparations for two other clinical trials related to the “quality of life” of patients with advanced pancreatic cancer and other abdominal tumors. These clinical trials deal with treatments for the: (i) intractable and virtually untreatable pain about 20-25% of patients with advanced pancreatic cancer suffer from; and (ii) accumulation of fluid (knows as ascites) in the abdomen that is extremely uncomfortable for patients with pancreatic cancer and other abdominal tumors. Because ascites fluid can contain cancer cells and these cells can seed and form new tumors, oncologists must frequently remove ascites fluid from patients. This is costly and painful. There is no treatment on the market to slow down the accumulation of ascites fluid. We believe our treatment will. We expect to start both clinical trials late in the third quarter of 2015.

We commenced and concluded our first preclinical study (4 groups of tumor bearing mice) that was conducted by Translational Drug Development (TD2) in the U.S. to determine the ability of our treatment of Cell-in-a-Box® plus ifosfamide to delay the accumulation of malignant ascites fluid. An expanded study (12 groups of mice) is currently being conducted by TD2. This study is designed to further define the parameters that will be needed for our future clinical trial in this area.

Our treatment for advanced, inoperable pancreatic cancer was granted the Orphan Drug designation by the U.S. Food and Drug Administration (FDA) in December 2014. Granting of this designation means that PharmaCyte Biotech will receive 7 years of marketing exclusivity in the U.S. for its pancreatic cancer treatment and reduced taxes and assistance from the FDA in the further development of our treatment.

We obtained the worldwide rights to use a genetically modified cell that produces insulin on demand in direct proportion to the amount of glucose (sugar) in their surroundings. These rights were obtained from the University of Technology Sydney (UTS) where Prof. Ann Simpson, along with her colleagues at UTS, have spent years developing this unique cell line called “Melligen.”

We have completed a study at the University of Veterinary Medicine Vienna (UVM) to determine if the Melligen cells have the propensity to form tumors in the body. The Melligen cells were found to be as “safe” as the genetically modified cells used in the previous clinical trials in pancreatic cancer in terms of potential tumor formation in the body over time. We have also begun studies to establish the parameters by which the Melligen cells can produce and store insulin in response to glucose levels in their surroundings.

Through a Collaborative Research Agreement with the Vorarlberg Institute for Vascular Investigation and Treatment in Austria, Dr. Eva-Maria Brandtner has been appointed our Director of Diabetes Program Development. Dr. Brandtner was responsible for studies with the Melligen cells during her previous tenure with our partner, Austrianova, as its Chief Scientist.

An international Diabetes Consortium has been established by PharmaCyte Biotech. The Diabetes Consortium brings together a global coalition of world class experts from various universities and institutions in several countries around the world. All 16 members of the Consortium are committed to developing a treatment for insulin-dependent diabetes using PharmaCyte Biotech’s Cell-in-a-Box® live-cell encapsulation technology combined with human non-pancreatic, insulin-producing cells.

Several contracts and Collaborative Research Agreements have been entered into with leading research universities, scientists, academics and institutions around the globe that will facilitate PharmaCyte Biotech’s development of its cancer and diabetes treatments.

We obtained the exclusive worldwide license from Austrianova to use the Cell-in-a-Box® live cell encapsulation technology in combination with compounds obtained or developed from constituents of Cannabis, known as cannabinoids, for the treatment of diseases and their related symptoms.

- Progress is underway at the University of Northern Colorado in an attempt to identify a cell line that can be encapsulated using the Cell-in-a-Box® technology, which, in turn, can be used together with cannabinoid or cannabinoid-like prodrugs as treatment for deadly and difficult to treat cancers, such as brain cancer.

- The company changed its name from Nuvilex, Inc. to PharmaCyte Biotech, Inc. to emphasize that it has fully transitioned from a nutraceutical company to a purely biotechnology company.

- Significant changes have been made at the Board of Directors level, including a new member with major pharmaceutical experience being named as our first replacement Board member. Others members are in the final interview process, all of whom will be widely experienced in the life sciences.

http://www.pharmacytebiotech.com/qa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction/