Shareholder update...
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today provided shareholders with an update on developments on progress in its cancer and diabetes programs and at the corporate level.
Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech, stated, "Given all of the developments that have occurred since our last update, we believe it is an appropriate time to update our shareholders on developments and to highlight and briefly summarize what is in store for PharmaCyte Biotech in the coming days. Before doing so, however, we would like to address two issues that reportedly are of significant concern to a number of our shareholders. The first has to do with whether a reverse stock split is imminent. The second is whether we have access to capital to move forward with our clinical trials. PharmaCyte Biotech has no current plans to effectuate a reverse stock split. In addition, our cash position remains strong and our ability to raise capital continues to be very favorable."
"As to the update, we remain focused on bringing our diverse platform technology to market and firmly believe our novel Cell-in-a-Box-based treatment will become a household name in the future. Our priority is and always has been to maximize shareholder value, and we are working diligently to reach that objective," added Mr. Waggoner.
Progress in the Cancer Program
PharmaCyte Biotech's treatment (Cell-in-a-Box® plus low-doses of ifosfamide) for advanced, inoperable pancreatic cancer was granted the Orphan Drug designation by the U.S. Food and Drug Administration (FDA) in late December of 2014.
On the basis of very positive results from 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 the Cell-in-a-Box® plus low-doses of ifosfamide combination to delay the accumulation of malignant ascites fluid produced by abdominal cancers, an expanded study (12 groups of mice) is currently being conducted by TD2. This study is designed to elucidate parameters that will be needed for a future clinical trial that may result in the only treatment that can slow down the accumulation of malignant ascites fluid. It is expected that the study will be completed in the next 2 months. The target date for the initiation of the Phase 1 clinical trial in the U.S. is the third quarter of 2015.
Preparations for the Phase 2b clinical trial in patients with advanced, inoperable pancreatic cancer are ongoing. Major documents, including the Investigators Brochure and a clinical protocol (a recipe for conducting the clinical trial) are in preparation, with the assistance of Clinical Network Services (CNS) - one of Australia's leading Clinical Research Organizations. The target date for the initiation of the Phase 2b clinical trial in Australia is the third quarter of 2015.
We initially reported that we expected to begin our Phase 2b clinical trial in the first quarter of 2015; however, we are awaiting the Good Manufacturing Practices (GMP) regulatory approval process that our partner, Austrianova, is currently involved with in order to get the GMP-compliant facility at the Thai Science Park in Bangkok, Thailand, approved to produce Cell-in-a-Box® capsules for human clinical trials. Austrianova believes the process will now be completed in the third quarter of 2015.
Progress is ongoing 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 a treatment for deadly cancers - such as brain and pancreatic cancer.
Progress in the Diabetes Program
Studies are in progress at the University of Veterinary Medicine, Vienna (UVM) to determine if Melligen (human, non-pancreatic, insulin-producing) cells are tumorigenic and to establish parameters by which these cells (human, non-pancreatic, insulin-producing) can produce and store insulin in response to glucose levels in their surroundings. The coordinator for these studies is Dr. Constantine Konstantoulas of UVM.
An exclusive license to use the Melligen cells developed by Prof. Ann Simpson of the University of Technology Sydney (UTS) in Australia has been obtained from UTS by PharmaCyte Biotech from UTS.
Dr. Eva-Maria Brandtner has been appointed Director of the Diabetes Research Program. Dr. Brandtner, presently at the Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT) in Austria, was responsible for studies with the Melligen cells during her previous tenure with our partner, Austrianova, at its Chief Scientist.
Developments at the Corporate Level
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.
Changes have been and are being made at the Board of Directors level, with additional member candidates to the Board in their final interview process; these new members will be widely experienced in the life sciences.
Waggoner concluded, "We are pleased to offer this update to our shareholders. We trust that they will agree that significant progress is being made on all fronts."
