PharmaCyte Biotech’s Encapsulation Facility for Pancreatic Cancer Therapy Deemed Suitable by Thai FDA
April 08 2016 - 9:20AM
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 reported that the encapsulation
facility located in Bangkok, Thailand, that will be used to
encapsulate the live cells used for PharmaCyte’s pancreatic cancer
therapy has recently been inspected by the Food and Drug
Administration of Thailand (Thai FDA). In its report on that
inspection, the Thai FDA stated that, “The facility is built
according to the pre-approved floor plan and is now deemed suitable
for the manufacture of pharmaceutical products.”
PharmaCyte Biotech’s Chief Executive Officer,
Kenneth L. Waggoner, commented, “We are very pleased that our
partner, Austrianova, has received a positive opinion from the Thai
FDA for Austrianova’s live-cell encapsulation facility. This is an
important milestone in the development of PharmaCyte’s treatment
for pancreatic cancer and a pre-requisite for our upcoming
pancreatic cancer clinical trial.”
The main role of the Thai FDA is to protect
consumer’s health, especially, to ensure safety, quality and
efficacy of health products within its purview. These products
include: foods, drugs, psychotropic substances, narcotics, medical
devices, volatile substances, cosmetics and hazardous substances.
It is an absolute requirement that the construction and operation
of Austrianova’s live-cell encapsulation facility be in accordance
with both Thai national legislation as well as international
agreements.
PharmaCyte’s product for pancreatic cancer will
be manufactured in Austrianova’s facility in Bangkok. It consists
of live human cells that have been genetically engineered to
convert the anticancer prodrug ifosfamide into its “cancer-killing”
form and then encapsulated using the Cell-in-a-Box® encapsulation
technology. In PharmaCyte’s upcoming clinical trial, these
encapsulated live cells will be used with low doses of ifosfamide
(one third the normal dose) as a “consolidation therapy” with the
current standard of care for advanced pancreatic cancer when a
patient no longer benefits from first line therapy. PharmaCyte’s
therapy will be compared with the combination of the anticancer
drug capecitabine plus radiation in patients with locally advanced,
non-metastatic, inoperable pancreatic cancer whose tumors are
stable or progressing after 4-6 cycles of treatment with either the
combination of Abraxane® plus gemcitabine or the four-drug
combination known as FOLFIRINOX.
About PharmaCyte BiotechPharmaCyte 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 and diabetes are being developed.
PharmaCyte’s treatment for cancer involves encapsulating
genetically modified live cells that convert an inactive
chemotherapy drug into its active or “cancer-killing” form. These
encapsulated live cells are placed as close to a cancerous tumor as
possible. Once implanted in a patient, a chemotherapy drug which
needs to be activated in the body (ifosfamide) is then given
intravenously at one-third the normal dose. The ifosfamide is
carried by the circulatory system to where the encapsulated cells
have been placed. When the ifosfamide, which is normally activated
in the liver, comes in contact with the encapsulated live cells,
activation of the chemotherapy drug takes place at the source of
the cancer without any side effects from the chemotherapy. This
“targeted chemotherapy” has proven remarkably effective and safe to
use in past clinical trials.
In addition to developing a novel treatment for
cancer, PharmaCyte is developing a treatment for Type 1 diabetes
and Type 2 insulin-dependent diabetes. PharmaCyte plans to
encapsulate a human cell line that has been genetically engineered
to produce, store and release insulin in response to the levels of
blood sugar in the human body. The encapsulation will be done using
the Cell-in-a-Box® technology.
Safe Harbor This press release may contain
forward-looking statements regarding PharmaCyte 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 or its
management, are intended to identify forward-looking statements.
Important factors, many of which are beyond the control of
PharmaCyte, 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’s intellectual property and PharmaCyte’s continued
ability to raise capital. PharmaCyte 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