PharmaCyte Biotech Announces Additional Quality Control Assay and Confirms Stability of CypCap Cells
July 05 2022 - 8:30AM
Business Wire
PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company
focused on developing cellular therapies for cancer, diabetes and
malignant ascites using its signature live-cell encapsulation
technology, Cell-in-a-Box®, today announced the results of a study
to determine whether a previous established quantitative real-time
PCR (qRT-PCR) could be used as a quality control test for
its CypCaps™ product candidate. The qRT-PCR was used to gain data
from testing of syringes from clinical batches of PharmaCyte’s cGMP
production for its planned clinical trial in locally advanced,
inoperable pancreatic cancer.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner,
commented on this new confirming assay, saying, “With the
completion of this study, the Company has fulfilled one more
important item from the long list of required U.S. Food and Drug
Administration (FDA) tasks for our pancreatic cancer product
candidate. We are particularly pleased that this independently
performed qRT-PCR shows yet again the stability at the genetic
level of the cytochrome P450 expressing cells which form the engine
for our CypCaps clinical trial product. Additionally, we continue
to make uninterrupted progress and remain steadfast in our efforts
to resubmit an Investigational New Drug Application to the FDA and
have our clinical hold lifted.”
The study, performed by a third-party laboratory, confirmed that
the qRT-PCR can be successfully implemented for testing, and it
also confirmed the identity and stability of the cytochrome P450
expression construct in the cells used for the production of
CypCaps both before and after encapsulation in the cGMP batches.
The qRT-PCR will thus be used as a quality control (QC) release
assay on future cGMP-grade clinical batches of CypCaps. The results
obtained from the newly reported study also serve as additional
evidence that the integrated cytochrome P450 construct is highly
stable in the clinical cell line used for CypCaps.
PharmaCyte is at the tail end of its process of fulfilling the
FDA’s requests to enable the clinical hold to be lifted, having now
successfully completed almost two dozen studies with only a few
remaining to be completed. The Company expects to commence its
two-phase pig study shortly, which is the last major study from the
FDA.
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, diabetes and malignant ascites 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,
diabetes and malignant ascites 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 candidate 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.
PharmaCyte’s therapy for malignant ascites involves using the
same encapsulated cells PharmaCyte employs for pancreatic cancer
but placing the encapsulated cells in the peritoneal cavity of a
patient and administering ifosfamide intravenously.
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 PharmaCyte’s
management and Board of Directors. Any statements contained in this
press release which do not describe historical facts are
forward-looking statements 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
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://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/20220705005292/en/
Investor Relations: PharmaCyte Biotech, Inc. Telephone:
917.595.2856 Email: InvestorRelations@PharmaCyte.com Attn: Dr.
Gerald W. Crabtree
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