PharmaCyte Biotech Announces Cell Encapsulation Technology Material Does Not Cause Skin Irritation
November 12 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®, announced today that the empty capsule material
that makes up its CypCaps™ pancreatic cancer product does not cause
skin irritation.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said,
“We continue to demonstrate that our pancreatic cancer product is
safe and performs just as we presented it in the Investigational
New Drug application (IND) we submitted to the U.S. Food and Drug
Administration (FDA). This latest positive data on the CypCaps
product is one more example that brings us closer to updating our
full package of information to address the FDA’s comments on our
initial IND submission.
“This latest study demonstrates conclusively that the capsule
material is not an irritant to the skin and confirms previously
submitted data that the capsule material of our CypCaps product is
inert. This result strengthens one of our responses to the FDA
concerning our IND requesting a clinical trial for locally
advanced, inoperable pancreatic cancer.”
The skin irritation study, which was performed by a third-party
Contract Research Organization, involved the ISO compliant testing
of an extract of empty cellulose sulphate capsules for
intracutaneous reactivity in New Zealand white rabbits. The study
was performed in compliance with the OECD Principles of Good
Laboratory Practice [C(97)186/Final and ENV/MC/CHEM (98)17] and in
accordance with ISO 10993 Part 10:2010(E). The extracts were
injected intracutaneously at five different sites on the anterior
part of the trunk of the rabbits, and the animals were observed for
3 days. After injection, there were no clinical signs of toxicity
or mortality in any of the animals. Furthermore, no
treatment-related changes were seen in the body weights of the
rabbits after administration of the empty capsule extract.
Importantly, none of the animals revealed treatment-related skin
reactions during the 72-hour observation period. Thus, it was
concluded that the extracts of empty cellulose sulphate capsules
are not a skin irritant in the New Zealand white rabbits.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211112005296/en/
Investor Relations: Dr. Gerald W. Crabtree PharmaCyte
Biotech, Inc. Telephone: 917.595.2856 Email:
InvestorRelations@PharmaCyte.com
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