PharmaCyte Biotech Successfully Completes Another FDA Required Study Necessary for Submitting Investigational …


LAGUNA HILLS, Calif.–()–PharmaCyte
Biotech, Inc.
(OTCQB: PMCB), a clinical stage biotechnology company
focused on developing targeted cellular therapies for cancer and
diabetes using its signature live-cell
encapsulation technology, Cell-in-a-Box®,
today announced
that it has successfully completed the comprehensive characterization of
its proprietary cell clone known as 22P1G.

The 22P1G cells constitute the cells in the Master Cell Bank (MCB) that
were prepared and tested by PharmaCyte’s contractor, Eurofins Lancaster
Laboratories. The cells from the MCB will serve as the active
pharmaceutical ingredient (API) in the company’s Cell-in-a Box®
capsules that will be used (together with low doses of the cancer
prodrug ifosfamide) for the treatment of locally advanced,
non-metastatic, inoperable pancreatic cancer (LAPC) in its planned
clinical trial.

The comprehensive characterization studies include long-term stability
of the cells, and stability of the potency of the cells as a
therapeutic. All studies performed are required by the U.S. Food and
Drug Administration (FDA).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, elaborated on
the significance of the studies saying, “PharmaCyte is complying with
all of the FDA guidelines and recommendations for all cell tests and
other recent studies with the 22P1G cells. Successful completion of
these studies was a pre-requisite for the approval by the FDA for us to
conduct a clinical trial in patients with LAPC. Our treatment is
primarily dependent upon genetically engineered live-human cells that
produce a particularly potent cytochrome P450 enzyme that can activate
the chemotherapy prodrug ifosfamide (clone 22P1G cells).

“With each individual batch, these cells must be stable for the long
term, and the properties of the 22P1G cells must remain consistent from
batch to batch. The newly completed studies provide evidence that both
requirements have been met. Our pancreatic cancer treatment utilizes
22P1G cells that have been encapsulated using the Cell-in-a-Box®
technology. For treatment of LAPC patients, the capsules containing the
cells are implanted near the pancreatic tumor so that a high local
concentration of the cancer-killing ifosfamide metabolite is produced
near the tumor.”

About PharmaCyte Biotech

PharmaCyte Biotech is a clinical stage 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 will be 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 results in 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, store and release insulin in response
to the levels of blood sugar in the human body and/or beta islet cells.
The encapsulation will be done using the Cell-in-a-Box®
technology. Once the encapsulated cells are implanted in a diabetic
patient, they will function as a “bio-artificial pancreas” for purposes
of insulin production.

Safe Harbor

This press release contains forward-looking statements, which are
generally statements that are not historical facts. Forward-looking
statements can be identified by the words “expects,” “anticipates,”
“believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and
similar expressions. Forward-looking statements are based on
management’s current plans, estimates, assumptions and projections, and
speak only as of the date they are made. We undertake no obligation to
update any forward-looking statement because of new information or
future events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which are
difficult to predict and are generally beyond our control. Actual
results or outcomes may differ materially from those implied by the
forward-looking statements due to the impact of numerous risk factors,
many of which are discussed in more detail in our Annual Report on Form
10-K and our other reports filed with the Securities and Exchange
Commission.

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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