PharmaCyte Biotech Successfully Completes 36 Month Master Cell Bank Stability Study
December 28 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 that it has successfully completed
a 36-month stability study of the cells from its Master Cell Bank
(MCB). These cells will be encapsulated and then used to treat
locally advanced, inoperable pancreatic cancer (LAPC). This
stability study is one of the items that the U.S. Food and Drug
Administration (FDA) requires PharmaCyte to complete for its
clinical trial product, CypCaps™, in an effort to lift the FDA’s
clinical hold. This means that the cells used to produce the
CypCaps have a shelf life of at least 36 months when stored in a
vapor phase of liquid nitrogen. Vapor phase temperature for liquid
nitrogen is between -140°C and -180°C.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said
of the completed 36-month stability study, “The ongoing study to
determine the maximum shelf life of the MCB cells has reached
another important milestone. Cells from our MCB successfully
completed the required tests to prove that the cells are stable and
remain active after being stored frozen for 36 months in a vapor
phase of liquid nitrogen.
“Analysis of the cells from our MCB after 36 months showed that
the cells passed all of the specified tests, including cell
viability, identity testing, sterility, enzyme activity and cell
potency as well as pH, label check and appearance of the cells.
“This study will continue in order to determine the maximum
shelf life of the cells from our MCB. It is distinct from the other
ongoing stability study on the shelf life of our CypCaps that
continue to be stored at approximately -80°C. While the storage
temperatures are different for the MCB cells and the CypCap cells,
the tests for both stability studies are the same.”
This ongoing stability study was initiated prior to the
submission of PharmaCyte’s Investigational New Drug Application
(IND) to the FDA. The information and data obtained from this
stability study and other studies will form part of PharmaCyte’s
Complete IND Submission of information that PharmaCyte will provide
to the FDA to have the clinical hold lifted.
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/20211228005018/en/
Investor Relations: Dr. Gerald W. Crabtree PharmaCyte
Biotech, Inc. Telephone: 917.595.2856 Email:
InvestorRelations@PharmaCyte.com
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