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 an interview-style
Q&A article that discusses the company’s Cannabis Research
Program with Mark L. Rabe, MD, the Director of PharmaCyte’s
Cannabis Program Development.
Given the latest research recently presented by
Dr. Hyslop and his colleagues at the University of Northern
Colorado (UNC), what are your thoughts about the future of
PharmaCyte's Cannabis Research Program?
Dr. Mark Rabe: “The latest news
from Dr. Hyslop and the UNC team was very encouraging. As a result,
PharmaCyte’s Cannabis Research Program is in high gear. The UNC
research focuses on developing targeted cannabinoid-based
chemotherapy utilizing the Cell-in-a-Box® live-cell encapsulation
technology.
“The therapy is designed to work by implanting
encapsulated engineered cells in a blood vessel near a tumor. Then,
a prodrug is administered upstream and activated by the
encapsulated cells at the site of the tumor. Cell-in-a-Box®, which
encapsulates cells in a bio-inert cellulose-based porous polymer,
serves as the platform. Of significance, UNC reported that
cannabidiol (CBD), a cannabinoid molecule derived from the Cannabis
plant, had anti-cancer effects against several types of cancer
cells that were dose-related. It was also reported that an enzyme
has been identified that could convert an inactive drug, or
“prodrug,” form of cannabinoid molecules into the corresponding
active chemotherapeutic forms.
“Work is now underway to engineer human cells to
produce this enzyme. Importantly, the ‘parental’ or originating
cell line being used is identical to that being used by PharmaCyte
for its pancreas cancer therapy, which is soon to enter a pivotal
clinical trial.”
If the cell line that PharmaCyte uses in its
pancreas cancer treatment does in fact work with Cannabis as well,
what is the significance of this find given how much work has
already been done on that cell line?
Dr. Mark Rabe: “Utilizing the
same parental cell line is a major advantage. Earlier work and
studies have shown that the cell line being utilized is very
amenable to Cell-in-a-Box® live-cell encapsulation. Further, this
cell line is about to receive additional FDA evaluation as part of
PharmaCyte’s upcoming pivotal clinical trial in the treatment of
locally advanced pancreas cancer. In that trial, the treatment’s
parental cell line has been engineered to produce an enzyme that
converts the conventional chemotherapy drug ifosfamide, which is a
prodrug, into its active form. PharmaCyte’s Cell-in-a-Box® therapy
is a biologic, which means it faces far greater regulatory hurdles
compared to treatments that use a single molecule. In our opinion,
when it comes time to present a Cell-in-a-Box®/cannabinoid therapy
to the FDA, substantial data supporting the parental cell line
choice will already exist.”
Walk us through the process of how cannabinoids
work and how PharmaCyte's therapy can make the cannabinoids work
better/be more effective?
Dr. Mark Rabe: “This question
addresses the ‘active’ component of the therapy. The medical
literature is full of evidence that cannabinoids, specifically CBD
and tetrahydrocannabinol (THC), exert anti-cancer properties in
several ways. They: (i) slow the growth of tumor cells; (ii) slow
the penetration of blood vessels into tumors that cause metastasis;
and (iii) promote programmed cancer cell death. Cannabinoids are
believed to exert these actions through interactions with
endocannabinoid receptors located on cell membranes and the
intracellular processes that control the cancer process.
“Presently, patients who choose to treat cancer
with cannabinoids do so by consuming it. The general approach used
is like that of conventional chemotherapy. That is, use as much as
safely possible to maximize the concentration of the
chemotherapeutic agent at the site of a tumor. However, generalized
side effects from large doses of cannabinoids, such as unwanted
psychoactivity and sedation, often limit their use. Control over
cannabinoid composition is also difficult. The goal of targeted
therapy is to optimize drug concentration at the site of a tumor
while minimizing side effects.”
Can you explain what it is that the eventual
cell line being encapsulated would be activating in PharmaCyte's
therapy?
Dr. Mark Rabe: “This question
addresses the ‘prodrug’ component of the therapy. As mentioned,
PharmaCyte’s therapy is designed to utilize an engineered cell line
which, when encapsulated with Cell-in-a-Box®, will enzymatically
convert a cannabinoid prodrug into its active form. Since the UNC
research and numerous other studies have confirmed that
cannabinoids like CBD and THC have anti-cancer properties, it is
necessary to have an inactive, or prodrug, version of these
molecules suitable for enzymatic conversion.
“We have several prodrug options. For example,
in the Cannabis plant, CBD and THC have naturally existing
precursors that could be activated. Another approach is to modify
CBD and/or THC in such a way as to render the molecules inactive. A
cell line that produces an enzyme to un-modify the modified
molecules would then generate the active drug.”
In what therapeutic areas do you envision
PharmaCyte's therapy being able to work?
Dr. Mark Rabe: “Cell-in-a-Box®
is extremely well-suited for targeted chemotherapy where prodrugs
are enzymatically converted into active drugs at the site of a
tumor. The platform can be used with conventional agents, such as
ifosfamide, and potentially with cannabinoids. Tumor targets
include any solid tumor, including pancreas, brain, breast,
prostate, liver and others.
“The Cell-in-a-Box® platform also has potential
application in the treatment of other diseases. For example,
cannabinoids have well-documented pain-relieving and
neuroprotecting effects. Cannabinoids have also been shown to have
beneficial effects in the treatment of diseases like Alzheimer’s
disease and diabetes. The challenge with such treatments, in
addition to answering the prodrug/active drug and cell line
questions, is optimizing dosing. The beauty of Cell-in-a-Box®,
however, is that the capsule size, and consequently the number of
cells contained, can be controlled. Hence, controlled micro-dosing
is possible.”
Do we know where PharmaCyte fits into the
current landscape with regard to creating a therapy in this space?
Are there competitors?
Dr. Mark Rabe: “The current
U.S. medical Cannabis industry has been estimated to be worth about
$3.0 billion, and it is expected to more than double as more states
legalize the use of Cannabis as medicine. There are dozens of
companies in the space. Multi-billion-dollar big pharma companies
such as Merck, Sanofi-Aventis, AbbVie and Bristol-Meyers Squibb
hold cannabinoid-related patents and are conducting
cannabinoid-related research. These companies also have broad
oncology portfolios.
“GW Pharmaceuticals is a U.K.-based
Cannabis-focused company with a market cap of approximately $3
billion. GW Pharmaceuticals has an extensive patent portfolio and
already has an approved product, Sativex®. Another GW product,
Epidiolex®, is in clinical trials. There is also an array of
smaller, publicly traded specialty pharma, drug delivery and
Cannabis-focused companies developing various cannabinoid-based
therapies.
“Within this landscape, PharmaCyte’s product is
quite unique and offers substantial potential benefits over other
approaches, including a bio-inert targeted delivery system, control
over the number of activating cells and control over prodrug
selection and dosing. If they haven’t already, I would think that
many of these companies will be taking notice of PharmaCyte’s
cannabinoid therapy as a great potential partnering or licensing
opportunity.”
What is the process moving forward with the
development of PharmaCyte’s therapy using cannabinoids?
Dr. Mark Rabe: “Work will
continue at UNC to study the anti-cancer effects of cannabinoids as
well as to complete development of the cell line. Then, the cell
line’s ability to convert a prodrug into an active drug will be
analyzed. If it works, these cells will then be encapsulated with
Cell-in-a-Box® and tested in animal cancer models. At the same
time, we are also exploring other possible uses of Cell-in-a-Box®
in combination with cannabinoids.”
With the current climate in this country in the
Cannabis sector, what are your expectations for PharmaCyte's
ability to create a therapy and get it into clinical trials?
Dr. Mark Rabe: “Developing a
new therapy is a complicated process, particularly when utilizing a
breakthrough technology such as Cell-in-a-Box®. To date, PharmaCyte
has successfully completed many of the necessary steps with only a
few to go. Ongoing work in the remaining areas is promising. One
challenge that we have experienced related to development of a
cannabinoid-based therapy is working within existing U.S. laws and
drug schedules. For example, it took over two years to obtain the
necessary licensure and approved Cannabis research material. With a
new administration in Washington, it remains an open question as to
whether getting a product that utilizes cannabinoid molecules into
U.S. clinical trials and available to patients will become harder
or easier.
“Interestingly, in contrast to the U.S., Israel
has embraced medical Cannabis and is the world leader in
cannabinoid research and production with over 500 companies in the
sector and 120 ongoing studies and clinical trials. With estimates
that the global market for medical Cannabis may reach $50.0 billion
by 2025, the Israeli government is poised to allow these companies
to begin exporting their products and dominate the world
industry.”
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage
biotechnology company developing 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. These encapsulated cells are implanted as
close to the patient’s cancerous tumor as possible. 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 comes
in contact with the encapsulated cells they act as an artificial
liver and activate the chemotherapy drug at the source of the
cancer. This “targeted chemotherapy” has proven effective and safe
to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for
cancer, PharmaCyte is developing a treatment for Type 1 diabetes
and insulin-dependent Type 2 diabetes. PharmaCyte plans to
encapsulate 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. 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 in light 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 because of the impact of several 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. It can also be obtained by contacting
Investor Relations.
Contact:
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com