PharmaCyte Biotech Provides Update on Corporate Developments and Progress With Cancer and Diabetes Programs
March 16 2015 - 8:30AM
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."
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company
focused on developing and preparing to commercialize treatments for
cancer and diabetes based upon a proprietary cellulose-based live
cell encapsulation technology known as Cell-in-a-Box®. This unique
and patented technology will be used as a platform upon which
treatments for several types of cancer, including advanced,
inoperable pancreatic cancer, and diabetes are being built.
PharmaCyte Biotech's treatment for pancreatic cancer involves low
doses of the well-known anticancer prodrug ifosfamide, together
with encapsulated live cells, which convert ifosfamide into its
active or "cancer-killing" form. These capsules are placed as close
to the cancerous tumor as possible to enable the delivery of the
highest levels of the cancer-killing drug at the source of the
cancer. This "targeted chemotherapy" has proven remarkably
effective in past clinical trials. PharmaCyte Biotech is also
working towards improving the quality of life for patients with
advanced pancreatic cancer and on treatments for other types of
solid cancerous tumors. In addition, PharmaCyte Biotech is
developing treatments for cancer based upon chemical constituents
of the Cannabis plant, known as cannabinoids. In doing so,
PharmaCyte Biotech is examining ways to exploit the benefits of
Cell-in-a-Box® technology in optimizing the anticancer
effectiveness of cannabinoids, while minimizing or outright
eliminating the debilitating side effects usually associated with
cancer treatments. This provides PharmaCyte Biotech the rare
opportunity to develop "green" approaches to fighting deadly
diseases, such as cancer of the pancreas, brain and breast, which
affect hundreds of thousands of individuals worldwide every
year.
Safe Harbor
This press release may contain forward-looking statements
regarding PharmaCyte Biotech and its future events and results that
involve inherent risks and uncertainties. The words "anticipate,"
"believe," "estimate," "expect," "intend," "plan" and similar
expressions, as they relate to PharmaCyte Biotech or its
management, are intended to identify forward-looking statements.
Important factors, many of which are beyond the control of
PharmaCyte Biotech, could cause actual results to differ materially
from those set forth in the forward-looking statements. They
include PharmaCyte's ability to continue as a going concern, delays
or unsuccessful results in preclinical and clinical trials, flaws
or defects regarding its product candidates, changes in relevant
legislation or regulatory requirements, uncertainty of protection
of PharmaCyte Biotech's intellectual property and PharmaCyte
Biotech's continued ability to raise capital. PharmaCyte Biotech
does not assume any obligation to update any of these
forward-looking statements.
More information about PharmaCyte Biotech can be found at
www.PharmaCyteBiotech.com. It can also be obtained by contacting
Investor Relations.
CONTACT: Investor Relations Contacts:
Jamien Jones
Blueprint Life Science Group
Telephone: 415.375.3340 Ext. 103
jjones@bplifescience.com