PharmaCyte Biotech on Track to Commence Clinical Trials
March 27 2015 - 9:00AM
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 announced that the genetically
modified cells that are required for its three planned clinical
trials have been fully tested and are in the process of being
propagated to produce all of the cells necessary for the clinical
trials.
The cells being produced came from a fully characterized
single-cell clone of the cells that were used in the previous
clinical trials in pancreatic cancer. These cells are being grown
under conditions that comply with current Good Manufacturing
Practices (cGMP) standards.
One of PharmaCyte Biotech's clinical trials consists of a Phase
2b trial where PharmaCyte Biotech's pancreatic cancer treatment
will be compared "head-to-head" with the best available
chemotherapy (Abraxane® plus gemcitabine) for advanced pancreatic
cancer. The Phase 2b clinical trial will be conducted in Australia
by Clinical Network Services (CNS). PharmaCyte Biotech's pancreatic
cancer treatment consists of encapsulating the genetically modified
cells, using the Cell-in-a-Box® live cell encapsulation technology,
and placing the capsules with the live cells inside them near the
site of the cancerous tumor. The patient is then given an inactive
cancer drug, ifosfamide, intravenously at one-third the normal
dose. When the blood carrying the ifosfamide comes in contact with
the encapsulated cells the ifosfamide is converted into its
cancer-killing form.
Two additional clinical trials will be conducted in the U.S. by
Translational Drug Development (TD2). These trials will determine
the effectiveness of PharmaCyte Biotech's treatment in (i) reducing
the severe pain that occurs in patients with advanced pancreatic
cancer; and (ii) slowing the accumulation of malignant fluid
(ascites) that accompanies the development of pancreatic and other
solid cancerous tumors in the abdomen.
Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte
Biotech, stated, "We are very pleased that work being done to grow
the cells required for our clinical trials has proceeded according
to our plans. Together with our partner, Austrianova, we are
complying with all current regulatory guidelines to ensure that
these cells will be made available to us as quickly as possible so
we can commence our clinical trials in a timely fashion."
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