PharmaCyte Biotech Commences First Phase of Two-Phase Pig Study
July 21 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®, announced today that it has commenced
the pilot phase of its two-phase pig study. The pig study is the
last of several requirements PharmaCyte has complied with related
to the requests from the U.S. Food and Drug Administration (FDA) to
lift the clinical hold on PharmaCyte’s planned Phase 2b clinical
trial for locally advanced, inoperable pancreatic cancer
(LAPC).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner,
explained, “As part of the Investigational New Drug Application
process in preparation for our planned clinical trial in LAPC, the
FDA requested data in a large animal, such as a pig, which allows
for assessment of safety and distribution of CypCaps™
following infusion using the clinical route of application,
devices, and procedures.
“The study will be conducted in two phases. The first phase,
which began today, is a short pilot study in two pigs. The
objective of this pilot study is to assess microcatheter-based
delivery of CypCaps in the pancreatic arterial system. Volume of
dose, number of CypCaps, and treatment location will be evaluated
using imaging and histology. Also, the CypCaps used in the study
will contain radiopaque microspheres, which will be evaluated to
track the movement of the CypCaps.
“The data obtained from the pilot study will allow us to
finalize the full-scale pig study protocol, which will involve 90
pigs. We will then present the protocol to the FDA in our planned
Type A meeting which will provide us an opportunity to interact
with the FDA to receive guidance on this and several other
outstanding issues relating to the clinical hold. Subject to any
FDA-suggested modifications to the protocol, we are fully prepared
to carry on with the full-scale study. We feel that this strategy
will provide the greatest likelihood for ultimate success.”
The pilot study will involve two 90-pound Yorkshire pigs. They
will receive a single intra-arterial injection of 100 CypCaps into
the pancreatic arterial system through a microcatheter. Fluoroscopy
will be used to qualitatively evaluate parameters such as vascular
anatomy, treatment site suitability, and acute deployment
characteristics. Over the course of a week, the animals will be
clinically observed, given health and incision site checks, and
body weight and condition will be scored.
At the conclusion of the clinical phase, whole blood and serum
will be analyzed, and tissue will be collected including the
pancreas and adjacent areas and CT imaged to evaluate potential
spillover of the CypCaps containing radiopaque microspheres. After
CT imaging is performed, various tissue sections will be
histologically evaluated by a board-certified veterinary
pathologist. Light microscopy will be used to examine collected
tissues to evaluate for any adverse effects associated with
implantation of the CypCaps. Evaluation of pancreatic samples will
include the presence of microspheres, necrosis, fibroplasia,
fibrosis, inflammation, mineralization/ossification, and evidence
of vascular injury. Light microscopy of additional tissues will be
reviewed to assess for adverse effects associated with treatment,
including thrombosis, necrosis, inflammation, and presence of
embolic material.
Both phases of the pig study are being conducted by CBSET, Inc.,
located in Lexington, Massachusetts.
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 PharmaCyte’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/20220721005301/en/
Investor Relations: PharmaCyte Biotech, Inc. Telephone:
917.595.2856 Email: InvestorRelations@PharmaCyte.com Attn: Dr.
Gerald W. Crabtree
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