PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage
biotechnology company focused on developing targeted treatments for
cancer and diabetes using its signature live-cell encapsulation
technology, Cell-in-a-Box®, released today the first in a series of
articles that will serve to educate the public on its technology
and how it is used in the treatment of advanced pancreatic cancer.
These articles will be written by doctors, scientists and
oncologists who are associated with PharmaCyte Biotech’s upcoming
Phase 2b clinical trial. This first educational piece is authored
by PharmaCyte Biotech’s Chief Operating Officer, Dr. Gerald W.
Crabtree, with the goal of explaining PharmaCyte Biotech’s
treatment.
What is Cell-in-a-Box®?
With so many telephone calls, emails and articles describing our
technology and our treatment for pancreatic cancer incorrectly, as
PharmaCyte Biotech’s Chief Operating Officer and resident
scientist, I felt it was imperative to help our shareholders and
the public understand what our technology is and how it works
before we head into our clinical trial in humans. First, our
signature live-cell encapsulation technology, Cell-in-a-Box®, does
not encapsulate and deliver drugs to treat pancreatic cancer.
Cell-in-a-Box® is the name given to a technology by which
genetically modified living human cells are encapsulated in tiny
capsules or “protective cocoons.” The outer shell or the capsule is
made mainly of cotton, or more specifically of cellulose. The
capsules are not designed to, and cannot be used to, enclose small
molecules such as drugs.
The capsules have a diameter of the size of the head of a pin.
The outer shell of each capsule has tiny openings in it. These
openings are large enough to let nutrients enter into the capsule
and feed the live cells inside, and are large enough to allow waste
products and beneficial products produced by the cells to leave the
capsule. But these openings are too small to let the cells inside
the capsule leave. The cells inside the capsules thrive as they
consume nutrients, oxygen and other molecules delivered by the
blood supply. Most importantly, the openings in the outer shell of
the capsules are too small to let a patient’s immune system cells
into the capsules. If this were not the case, the cells of the
body’s immune system would get inside and rapidly destroy the cells
inside.
What Types of Cells are Encapsulated for
the Treatment of Pancreatic Cancer?
The cells that are encapsulated to treat pancreatic cancer are
human cells that have been genetically modified to produce an
enzyme that causes a biochemical reaction to take place. In humans,
this is part of an enzyme system known as the cytochrome P450
system.
The cytochrome P450 system in humans causes a biochemical
reaction to take place in the liver. Once an inactive chemotherapy
drug comes in contact with the liver through the blood circulatory
system, an inactive chemotherapy drug is converted from its
inactive form to its active or “cancer-killing” form.
What Drug is used with the Encapsulated
Cells to Treat Pancreatic Cancer?
PharmaCyte Biotech uses ifosfamide to kill cancer cells in a
patient with advanced pancreatic cancer. Ifosfamide is a prodrug –
meaning it needs to be activated before it is able to kill cancer
cells. The activation of ifosfamide into its “cancer-killing form”
is normally done by the cytochrome P450 enzyme system in the liver.
That is not the case with PharmaCyte Biotech’s treatment for
pancreatic cancer. As explained below, the activation takes place
before ifosfamide reaches the liver and right at the source of the
cancer.
What is PharmaCyte Biotech’s Pancreatic
Cancer Treatment and How Does it Work?
PharmaCyte Biotech’s pancreatic cancer treatment consists of
implanting encapsulated genetically modified live cells as close to
the tumor as possible and then giving a patient ifosfamide so that
the conversion of the ifosfamide takes place as close to the tumor
as possible. Each capsule contains approximately 10,000 genetically
modified cells, which efficiently convert ifosfamide into its
cancer-killing form. Ifosfamide is given to a patient at one-third
the normal dose after the encapsulated cells have been implanted.
This conversion enables the highest concentration of ifosfamide to
be converted at or near the tumor - rather than where it is
normally converted – in the liver.
The first step in the treatment is to implant 300 of the
capsules as close to the tumor as possible. This is done by
threading a catheter up through an artery in the leg leading to the
pancreas. This process is done by a special type of radiologist
known as an interventional radiologist. When the catheter is in
place, the capsules are injected through the catheter and placed at
or near the tumor in the pancreas. It is then that low-doses of
ifosfamide are given to a patient intravenously. The ifosfamide is
carried by the circulatory system to where the encapsulated cells
have been implanted. When the ifosfamide comes into contact with
the encapsulated live cells, the cells activate the ifosfamide to
its cancer killing form. This activation takes place at the source
of the cancer, delivering the highest concentration of ifosfamide
to attack the cancer cells. This activation occurs before the
ifosfamide has even reached the liver. Because ifosfamide is given
at one-third the normal dose, there are no side effects from
PharmaCyte Biotech’s treatment.
Is PharmaCyte’s Pancreatic Cancer
Treatment Effective?
In a previous clinical trial in elderly, very sick patients with
advanced, inoperable pancreatic cancer, PharmaCyte Biotech’s
treatment proved to be both effective and safe. When the data from
the trial were compared with historical data for the drug
gemcitabine, the only drug approved at the time to treat pancreatic
cancer, the encapsulated genetically modified live cells plus
low-dose ifosfamide combination treatment was superior in
anticancer effect to gemcitabine in terms of median survival time
of the patients and in terms of the percentage of one-year
survivors. Furthermore, no treatment-related side effects were
reported with this treatment compared to significant
treatment-related side effects with the gemcitabine therapy.
What is the Next Step for PharmaCyte
Biotech?
PharmaCyte Biotech is preparing to conduct a Phase 2b clinical
trial where the Cell-in-a-Box® plus low-dose ifosfamide combination
will be given to patients with locally advanced pancreatic cancer.
If successful, the Cell-in-a-Box® plus low-dose ifosfamide
treatment may become an effective option for patients with advanced
pancreatic cancer – one of the world’s deadliest forms of cancer –
that we believe will fulfill a longstanding unmet medical
need. More will be explained about this when we disclose the
design of the trial.
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company
focused on developing and preparing to commercialize treatments for
cancer and diabetes based upon a proprietary cellulose-based live
cell encapsulation technology known as “Cell-in-a-Box®” This unique
and patented technology will be used as a platform upon which
treatments for several types of cancer, including advanced
pancreatic cancer and its symptoms, and diabetes are being
developed.
PharmaCyte Biotech’s treatment for cancer involves encapsulating
genetically modified live cells capable of converting an inactive
chemotherapy drug (ifosfamide) into its active or “cancer-killing”
form. Ifosfamide is normally activated in the liver. These
encapsulated live cells are placed as close to a cancerous tumor as
possible. Ifosfamide is then given intravenously at one-third the
normal dose. It is carried by the circulatory system to where the
encapsulated cells have been placed. When the ifosfamide comes in
contact with the encapsulated live cells, activation of the drug
takes place before it gets to the liver at or near the tumor
without any side effects from the chemotherapy. This “targeted
chemotherapy” has proven remarkably effective and safe to use in
past clinical trials.
In addition to developing a novel treatment for cancer,
PharmaCyte Biotech is developing a treatment for Type 1 diabetes
and Type 2 insulin-dependent diabetes. PharmaCyte Biotech plans to
encapsulate a human cell line which has been genetically engineered
to produce, store and secrete insulin at levels in proportion to
the levels of blood sugar in the human body. The encapsulation will
be done using the Cell-in-a-Box® technology.
Safe Harbor
This press release may contain forward-looking statements
regarding PharmaCyte Biotech and its future events and results that
involve inherent risks and uncertainties. The words "anticipate,"
"believe," "estimate," "expect," "intend," "plan" and similar
expressions, as they relate to PharmaCyte Biotech or its
management, are intended to identify forward-looking statements.
Important factors, many of which are beyond the control of
PharmaCyte Biotech, could cause actual results to differ materially
from those set forth in the forward-looking statements. They
include PharmaCyte's ability to continue as a going concern, delays
or unsuccessful results in preclinical and clinical trials, flaws
or defects regarding its product candidates, changes in relevant
legislation or regulatory requirements, uncertainty of protection
of PharmaCyte Biotech’s intellectual property and PharmaCyte
Biotech’s continued ability to raise capital. PharmaCyte Biotech
does not assume any obligation to update any of these
forward-looking statements.
More information about PharmaCyte Biotech can be found at
www.PharmaCyte.com. It can also be obtained by contacting Investor
Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com