PharmaCyte Biotech Successfully Completes 24-Month Stability Study of Its Clinical Trial Product Candidate
March 22 2022 - 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 it has successfully completed
a 24-month product stability study required by the U.S. Food and
Drug Administration (FDA) for its clinical trial product candidate,
CypCaps™. The significance of this timepoint is that CypCaps has
now demonstrated that it has a shelf life of at least 24 months
when stored at -80oC.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said
of the completed 24-month stability study, “While we continue to
establish a maximum shelf life for our clinical trial product
candidate, CypCaps, reaching the 24-month timepoint is highly
significant in allowing PharmaCyte to store a biologic at -80oC. We
demonstrated that frozen CypCaps maintain their viability,
enzymatic activity and cell potency after 2 years of storage at
-80oC in a cryopreserved state. This is a major milestone not only
for PharmaCyte but also for the cell therapy field.”
After 24 months storage of the Cell-in-a-Box encapsulated cell
product, CypCaps, at -80oC, the product was thawed and analyzed for
cell viability, enzyme activity and cell potency as well as being
examined for pH, label integrity, capsule appearance, capsule
integrity and container closure integrity.
Notably, over the entire 24-month period, there was no
significant change in the number and viability of the encapsulated
cells, or, most importantly, in the biological activity that is key
to activating the anti-cancer mechanism PharmaCyte uses for its
cancer therapy. The successfully completed stability study was
initiated prior to the submission of the company’s IND to the FDA,
and the information and data obtained from the study will form part
of the updated package of information that will be provided to the
FDA, together with data from additional studies requested by this
regulatory agency.
This formal study, performed under GMP conditions, confirms
previous laboratory data generated by PharmaCyte’s partner,
Austrianova, showing cell viability and activity of a similar
Cell-in-a-Box cell encapsulation product upon storage in the frozen
state for over 6 years.
This data is remarkable and stands in stark contrast with data
obtained after cryopreservation of alginate encapsulated cells
where one study showed viability after 2 weeks storage (Nicola
Cagol, Walter Bonani, Devid Maniglio, Claudio Migliaresi, Antonella
Motta (2018) Effect of cryopreservation on cell-laden hydrogels:
comparison of different cryoprotectants. Tissue Eng. Part C Methods
24:20-31) and another using alginate encapsulated islets showed
viability when thawed after 4 weeks storage in a frozen state (Greg
G Kojayan, Antonio Flores, Shiri Li, Michael Alexander, and
Jonathan RT Lakey (2019) Cryopreserved alginate-encapsulated islets
can restore euglycemia in a diabetic animal model better than
cryopreserved non-encapsulated islets. Cell Medicine 11: 1-6).
Another study using cryopreserved cardiosphere-derived cells
encapsulated in alginate-poly-L-lysine-alginate microcapsules
showed viability of the cells after being revived 60 days after
storage in a frozen state (Paz-Artigas L, Ziani K, Alcaine C,
Báez-Díaz C, Blanco-Blázquez V, Pedraz JL, Ochoa I, Ciriza J.
(2021) Benefits of cryopreservation as long-term storage method of
encapsulated cardiosphere-derived cells for cardiac therapy: A
biomechanical analysis. Int J. Pharm. 607:121014).
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 function 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/20220322005532/en/
Investor Relations: Dr. Gerald W. Crabtree PharmaCyte
Biotech, Inc. Telephone: 917.595.2856 Email:
InvestorRelations@PharmaCyte.com
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