PharmaCyte’s CEO Discusses Development of its Pancreatic Cancer Therapy
September 15 2016 - 9:15AM
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®, today addressed shareholders on the
development of PharmaCyte’s therapy for advanced pancreatic cancer.
The Chief Executive Officer of PharmaCyte,
Kenneth L. Waggoner, commented, “We understand that shareholders
are frustrated with our current share price; however, the share
price doesn’t reflect where PharmaCyte is today. In what has been a
relatively short time for a biotech company, we have dramatically
moved our Cell-in-a-Box® technology forward along the path toward
the clinic, we have surrounded our technology with some of the best
minds in the industry and we have put together a team that is
working diligently every single day to get PharmaCyte in front of
the U.S. Food and Drug Administration (FDA) so that we can clear
the final hurdles that will allow us to begin our clinical trial in
advanced pancreatic cancer. There are numerous moving parts on many
fronts. Just because our shareholders aren’t seeing news on a
weekly basis, this does not mean there isn’t a flurry of work being
done every single day.
“It is important for our shareholders to realize
that PharmaCyte’s pancreatic cancer therapy is classified by drug
regulatory authorities as a ‘biologic’ rather than a single
molecule drug or a New Chemical Entity (NCE). This is because our
therapy involves the use of living, genetically altered human
cells. The overall development process is much more involved and
more complex for a biologic than an NCE. Nevertheless, PharmaCyte’s
therapy is moving forward at a realistic pace. Our partner
Austrianova will be carrying out an engineering manufacturing ‘run’
in the near future of the production of the capsules that will be
used with low dose ifosfamide as our pancreatic cancer therapy. If
successful, not only will this run define the specifications of the
capsules that will be use to encapsulate the living cells, it will
also set the stage for cGMP production of the capsules for our
planned clinical trial.
“An example of the different environment that
we’re working in is that biologic products - particularly
encapsulated living cell products like PharmaCyte’s and unlike most
pharmaceutical products which can be simply ‘end-sterilized’ and
delivered as sterile products - must be kept alive from the moment
the cells are thawed from the frozen research cell bank and then
encapsulated until they are implanted in a patient. At all times
during these operations our product must be kept free of
contamination by bacteria, yeast and fungi. Thus our biologic
product is more akin to a live vaccine or to a stem cell therapy.
The cell culture medium used to maintain the living cells within
the capsules is also an excellent growth medium for all of those
previously mentioned undesirable contaminants. Contaminant and
other testing of our research cell bank is underway at ViruSure,
one of PharmaCyte’s contractors, while Austrianova continues to
make steady progress in order to manufacture cGMP clinical trial
material that we will need to begin the trial.
“It goes without saying that great care has to
be taken at every step to ensure the maintenance of aseptic
conditions; this is one reason for carrying the production out in
an ‘isolator’ that prevents actual contact between production staff
and the product being manufactured. A living cell product also
brings with it new regulatory challenges. PharmaCyte has been
steadily working through these challenges with a number of
regulatory advisors both in the United States and in the United
Kingdom. These exciting new “Advanced Medicinal Products” are the
future of treatment for serious diseases, and in many ways
pioneering companies, like PharmaCyte, are working with the
regulators to lay the ground work for tomorrow’s regulatory
framework.”
About PharmaCyte Biotech
PharmaCyte Biotech 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 an “artificial pancreas” for purposes of
insulin production.
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 or its
management, are intended to identify forward-looking statements.
Important factors, many of which are beyond the control of
PharmaCyte, 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’s intellectual property and PharmaCyte’s continued
ability to raise capital. PharmaCyte 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