PharmaCyte Biotech Announces Encapsulation Material Does Not Alter Cellular DNA
September 27 2021 - 9:00AM
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 further results from a third test
of biocompatibility of its CypCaps™ product candidate for
pancreatic cancer. The tests results showed that the empty capsule
material is not “mutagenic.” A mutagen is a physical or chemical
agent that permanently changes genetic material, usually DNA, in an
organism and thus increases the frequency of mutations above the
natural background level.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said,
“As we continue to receive data from a myriad of tests that are
currently in progress, we are generating exactly the data we
expected to generate when we began addressing the U.S. Food and
Drug Administration’s desire to see more data. These latest test
results continue to support the safety of PharmaCyte’s product
candidate, CypCaps. In line with data generated previously, we are
confident that the encapsulation material used for CypCaps is
biocompatible, safe and not toxic. Each of the tests that we’re
conducting should continue to demonstrate this.”
The study, which was performed by a third-party Contract
Research Organization (CRO) in compliance with OECD Principles of
Good Laboratory Practice [C(97)186/Final and ENV/MC/CHEM (98)17]
and in accordance with four regulatory guidelines (OECD and ISO)
was designed to determine if the device component of CypCaps (the
empty capsule material) can cause mutations by altering DNA. The
specific objective of the study was to evaluate whether two
differently prepared extracts of empty capsule material can induce
reverse mutations in specific genes in four indicator strains of
bacteria Salmonella typhimurium and one indicator strain of
Escherichia coli. The third-party CRO concluded from the data
obtained that the empty capsule material is “non-mutagenic.”
To learn more about PharmaCyte’s pancreatic cancer treatment and
how it works inside the body to treat locally advanced inoperable
pancreatic cancer, we encourage you to watch the company’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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210927005167/en/
Investor Relations: Dr. Gerald W. Crabtree PharmaCyte
Biotech, Inc. Telephone: 917.595.2856 Email:
InvestorRelations@PharmaCyte.com
PharmaCyte Biotech (NASDAQ:PMCB)
Historical Stock Chart
From Aug 2024 to Sep 2024
PharmaCyte Biotech (NASDAQ:PMCB)
Historical Stock Chart
From Sep 2023 to Sep 2024