PharmaCyte Biotech Announces Successful Completion of Interim Audit of GMP Facility for the Production of Cell-in-a-Box for C...
August 25 2015 - 9:38AM
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®, provided an update on the progress of
completing the compliance process for Austrianova’s cGMP (current
Good Manufacturing Practices-compliant) facility in the Thai
Science Park in Bangkok, Thailand. This is the facility that will
encapsulate genetically modified human cells in the Cell-in-a-Box®
capsules PharmaCyte Biotech will use in its clinical trials in
cancer and diabetes.
Austrianova is in the process of completing
installation qualification, operational qualification and
performance qualification on the clean room and associated areas,
as well as all of the machines required for the manufacturing
process at its cGMP facility. As part of these activities,
Austrianova has just successfully completed an audit by an expert
who has been active in the pharmaceutical industry for more than 15
years and who has held a position at a leading European inspector
for cGMP inspections. Currently, the auditor is an external expert
for the World Health Organization (WHO), assisting in inspections
for the WHO prequalification program that ensures the safe and
secure supply of medical products for critical therapies. The
expert was retained to perform an audit of the facility in Bangkok
and Austrianova’s state of the art, web-based electronic quality
system.
Prof. Walter H. Günzburg, Chief Technical
Officer at Austrianova, said, “We are very pleased to announce that
the inspector did not find any major issues that would prevent the
cGMP production of Cell-in-a-Box®. The next step in the process is
to carry out the necessary engineering or “shake-down” runs at the
facility, which will involve running through the production process
and generating data on the qualified equipment. These tests are
required before the facility can start work on the production of
the three “consecutive runs” that will be used to demonstrate
compliance of the production process with cGMP standards.”
Commenting on the progress of Austrianova,
PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner,
said, “As with any biotechnology company developing new medical
products, our goal is to comply fully with all of the regulatory
requirements. In establishing this new production process, we and
Austrianova are starting from ‘ground zero.’ It is remarkable that
the very laborious, rigorous and intensive procedures that are
necessary for cGMP-compliant production are progressing so rapidly.
We are exceedingly pleased with the progress being made by
Austrianova.”
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 its related symptoms, as well as
diabetes are being developed.
PharmaCyte Biotech’s treatment for pancreatic
cancer involves encapsulating genetically modified human cells that
convert the prodrug ifosfamide into its active or “cancer-killing”
form. These encapsulated live cells are placed as close to the
tumor as possible to enable the delivery of the highest levels of
the cancer-killing drug at the source of the cancer. Ifosfamide is
then given intravenously at one-third the normal dose to eliminate
the side effects normally associated with chemotherapy. When the
ifosfamide comes in contact with the encapsulated live cells
through the circulatory system, the activation of ifosfamide takes
place at or near the tumor. This “targeted chemotherapy” has proven
remarkably effective and safe to use in past clinical trials.
PharmaCyte Biotech is also developing treatments
for cancer based upon the encapsulation of chemical constituents of
the Cannabis plant. It is examining ways to exploit the benefits of
the Cell-in-a-Box® technology in optimizing the anticancer
effectiveness of Cannabis, while at the same time minimizing or
outright eliminating the debilitating side effects often associated
with cancer treatments.
In addition to developing treatments for
pancreatic and other cancers, PharmaCyte Biotech is developing a
treatment for Type 1 diabetes and Type 2 insulin-dependent
diabetes. PharmaCyte Biotech plans to encapsulate a human cell line
which has been genetically engineered to produce, store and secrete
insulin on demand at levels in proportion to the levels of blood
sugar in the human body. The encapsulation of the insulin producing
live cells will be done using the Cell-in-a-Box® technology.
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.PharmaCyte.com. It can also be obtained by contacting
Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com