PharmaCyte Biotech Establishes 18-Month Shelf Life for Clinical Trial Product in Ongoing Stability Study
August 31 2021 - 9:20AM
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 its clinical trial product,
CypCaps™, remains stable and active at 18 months after completing
the 18-month timepoint of ongoing product stability testing
required by the U.S. Food and Drug Administration (FDA). This means
that the product has a shelf life of at least 18 months when stored
at -80oC. The next scheduled timepoint in the ongoing testing will
be after 2 years of storage at -80oC.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said
of the completed 18-month timepoint in its ongoing stability study,
“We are pleased to announce these extended stability conditions,
which will be included in our updated package of information that
we provide to the FDA with the goal of lifting the clinical hold on
our Investigational New Drug application (IND). This is an
important development and enables simpler distribution and more
flexibility at our clinical trial sites in the U.S. for our planned
Phase 2b clinical trial in locally advanced, inoperable pancreatic
cancer should the FDA grant us an open IND.”
Analysis after 18 months in storage at -80oC, the unfrozen
CypCaps product passed all the specified tests, including cell
viability, enzyme activity, cell potency, pH, label check, capsule
appearance and integrity. This ongoing stability study was
initiated prior to the submission to the FDA of the Company’s IND.
The information and data from the stability study will form part of
the updated package of information that PharmaCyte will provide to
the FDA, together with data from additional studies requested by
the FDA.
As noted in a recent review article in “Frontiers in Medicine”
by Meneghel and colleagues, stable cryopreservation is a key
element in the successful delivery of live cell-based therapies.
Meneghel J, Kilbride P and Morris GJ (2020) Cryopreservation as a
Key Element in the Successful Delivery of Cell-Based Therapies—A
Review. Front. Med. 7:592242. doi: 10.3389/fmed.2020.592242
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
https://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/20210831005328/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