PharmaCyte Biotech Updates Progress of cGMP Facility for the Production of Cell-in-a-Box for Clinical Trials
August 06 2015 - 9:30AM
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®, announced an update on the progress of
completing the certification of 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 both
cancer and diabetes.
Austrianova is in the process of completing
installation qualification, operational qualification and
performance qualification on each of the machines required for the
manufacturing process and cleanroom at the cGMP facility. After
completion, Austrianova will need to carry out the 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 pass
inspection by drug regulatory authorities.
Prof. Walter H. Günzburg, Chief Technical
Officer at Austrianova, said of the current cGMP process,
“Depending on how the engineering runs go, we may have to do two or
three runs. The data generated will be used to set the
‘Specifications’ that will be used for the cGMP encapsulation
process. Then we will have to carry out three ‘Validation Runs’
which we refer to as production runs. The data from all three runs
need to meet the Specifications. If one of these runs does not meet
the predefined Specifications, cGMP regulations require us to carry
on doing runs until at least three consecutive runs meet the
Specifications.”
He continued, “In parallel with this, two new
staff, including a head of quality control, have recently joined
our team. In addition, we are completing our Quality Documentation
on all aspects of the machinery used in the facility, the
environment within it, operations conducted and the encapsulation
process itself, as well as on materials used in the facility,
finished goods produced, cleaning procedures, personnel who will
work in the facility, etc. To enable this process to be completed
to international standards, we have arranged for an on site
inspection by a former-World Health Organization (WHO) cGMP
inspector. Her findings will give us guidance on which parts, if
any, of the Quality System may require additional fine-tuning.”
PharmaCyte Biotech’s Chief Executive Officer,
Kenneth L. Waggoner, commented on the progress of Austrianova, “The
very laborious, rigorous and intensive procedures that are
necessary to have a facility such as the encapsulation facility in
Bangkok deemed ‘cGMP-compliant’ are proceeding well on all fronts.
Our colleagues at Austrianova are working exceedingly hard to
ensure that the facility passes inspection by regulatory
authorities in as timely a fashion as possible. We are confident
that this entire process is in very good hands.”
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