PharmaCyte Biotech to Accelerate Preparations for Start of Pancreatic Cancer Clinical Trial
April 13 2022 - 09:00AM
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 PharmaCyte has decided to
accelerate preparations for the start of its Phase 2b clinical
trial in locally advanced, inoperable pancreatic (LAPC) using its
CypCapsTM clinical trial product.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said
of accelerating enrollment of the first patient, “The plan is to
begin the work now to prepare for the enrollment of the first
patient so that we can begin the trial almost immediately upon
getting the clinical hold lifted.
“Because we continue to receive favorable results from each of
the studies that we have conducted to satisfy the FDA’s
requirements and because of the company’s financial position, we
are ideally situated to begin the work necessary to enroll the
first patient now to run parallel with the work being done to get
the clinical hold lifted. Previously, our plan was to begin the
work to commence a clinical trial in LAPC after the FDA lifted the
clinical hold.”
The work to enroll the first patient includes finalizing the (i)
clinical trial protocol; (ii) pharmacy manual; (iii) investigator’s
brochure; (iv) angiography manual; (v) informed consent; and (vi)
drug product label.
PharmaCyte will also need to reengage with Medpace, the Contract
Research Organization that PharmaCyte has selected to conduct its
proposed clinical trial. PharmaCyte will also need to reengage its
subcontractors who will assist Medpace. Catalent Pharma Solutions,
PharmaCyte’s supply chain vendor, must also be reengaged and the
supply chain requirements must be updated.
Clinical trial syringes containing CypCaps™ will need to be
manufactured and delivered to Catalent’s locations throughout the
U.S. for storage and distribution for the clinical trial. Those
syringes have already been ordered from Austrianova and are in the
process of being manufactured.
The final list of cancer centers will need to be selected and
contracts must be negotiated and finalized with each center.
Also, the lead interventional radiologist must be selected, a
training film must be developed, and the lead interventional
radiologist will need to train additional interventional
radiologists.
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 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/20220413005367/en/
Investor Relations: Dr. Gerald W. Crabtree PharmaCyte
Biotech, Inc. Telephone: 917.595.2856 Email:
InvestorRelations@PharmaCyte.com
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