PharmaCyte Biotech Study Proves Capsule Material Is Not Toxic For Encapsulated Cells
January 04 2022 - 8:00AM
Business Wire
PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company
focused on developing cellular therapies for cancer and diabetes
using its signature live-cell encapsulation technology,
Cell-in-a-Box®, today announced that the empty capsule material
that makes up PharmaCyte’s CypCaps® pancreatic cancer product
candidate is not toxic for the encapsulated cells inside the
CypCaps.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said,
“We have completed another study that proves exactly what we
expected to find in the data. Like previous biocompatibility
studies on our CypCaps product candidate to treat locally advanced,
inoperable pancreatic cancer (LAPC), this study demonstrates that
the capsule material is not in any way toxic to our encapsulated
live cells. This study also confirms previously obtained data that
the capsule material is bio-inert.”
The study was performed to assess the cytotoxic (cell toxicity)
potential of extracts of cellulose sulphate capsules using a
standard line of mouse fibroblast cells known to be sensitive to
toxic influences. The study was performed in compliance with the
OECD Principles of Good Laboratory Practice [C(97)186/Final and
ENV/MC/CHEM(98)17], International Standard (ISO) 10993-5, Third
Edition 2009-06-01, “Biological Evaluation of Medical Devices -
Part 5: Tests for In vitro cytotoxicity,” and International
Standard (ISO) 10993-12, Fifth Edition 2021-01, “Biological
Evaluation of Medical Devices - Part 12: Sample preparation and
reference materials.”
Extracts of the capsule material were prepared by a third-party
Contract Research Organization (CRO) laboratory using physiological
saline or dimethyl sulphoxide (DMSO) as solvents. Different
concentrations of each of the extracts were added to mouse
fibroblast cells. The cells were examined 24 hours later under the
microscope by the CRO for any abnormal cell morphology and the
possible presence of cell lysis. The capsule material was found to
be “non-cytotoxic” to mouse fibroblast cells at all of the
concentrations examined.
To learn more about PharmaCyte’s pancreatic cancer treatment and
how it works inside the body to treat LAPC, we encourage you to
watch PharmaCyte’s documentary video complete with medical
animations at: https://www.PharmaCyte.com/Cancer
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. is a biotechnology company developing
cellular therapies for cancer and diabetes based upon a proprietary
cellulose-based live cell encapsulation technology known as
“Cell-in-a-Box®.” This technology is being used as a platform upon
which therapies for several types of cancer and diabetes are being
developed.
PharmaCyte’s therapy for cancer involves encapsulating
genetically engineered human cells that convert an inactive
chemotherapy drug into its active or “cancer-killing” form. For
pancreatic cancer, these encapsulated cells are implanted in the
blood supply to the patient’s tumor as close as possible to the
site of the tumor. Once implanted, a chemotherapy drug that is
normally activated in the liver (ifosfamide) is given intravenously
at one-third the normal dose. The ifosfamide is carried by the
circulatory system to where the encapsulated cells have been
implanted. When the ifosfamide flows through pores in the capsules,
the live cells inside act as a “bio-artificial liver” and activate
the chemotherapy drug at the site of the cancer. This “targeted
chemotherapy” has proven effective and safe to use in past clinical
trials and we believe results in little to no treatment related
side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent
Type 2 diabetes involves encapsulating a human cell line that has
been genetically engineered to produce and release insulin in
response to the levels of blood sugar in the human body. The
encapsulation of the cell line will be done using the Cell-in-a-Box
technology. Once the encapsulated cells are implanted in a diabetic
patient, we anticipate that they will function as a “bio-artificial
pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that express the current beliefs and expectations of the management
of PharmaCyte. Any statements contained herein that do not describe
historical facts are forward-looking statements that are subject to
risks and uncertainties that could cause actual results,
performance, and achievements to differ materially from those
discussed in such forward-looking statements. Factors that could
affect our actual results include our ability to raise the
necessary capital to fund our operations and to find partners to
supplement our capabilities and resources, our ability to
satisfactorily address the issues raised by the FDA in order to
have the clinical hold on our IND removed, as well as such other
factors that are included in the periodic reports on Form 10-K and
Form 10-Q that we file with the U.S. Securities and Exchange
Commission. These forward- looking statements are made only as of
the date hereof, and we undertake no obligation to update or revise
the forward-looking statements, except as otherwise required by
law, whether as a result of new information, future events or
otherwise.
More information about PharmaCyte Biotech can be found at
www.PharmaCyte.com. Information may also be obtained by contacting
PharmaCyte’s Investor Relations Department.
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version on businesswire.com: https://www.businesswire.com/news/home/20220104005118/en/
Investor Relations: Dr. Gerald W. Crabtree PharmaCyte
Biotech, Inc. Telephone: 917.595.2856 Email:
InvestorRelations@PharmaCyte.com
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