LAGUNA HILLS, Calif.–(BUSINESS WIRE)–#INDstatus—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 its Chief Executive Officer, Kenneth L. Waggoner, and his team are
now in Bangkok, Thailand. They have been attending meetings on site at
Austrianova’s GMP manufacturing facility. Production of PharmaCyte’s
clinical trial material for the treatment of locally advanced,
non-metastatic, inoperable pancreatic cancer (LAPC) is already underway.
On Tuesday, June 11, Mr. Waggoner and PharmaCyte’s consultant cellular
biologist, David A. Judd, will observe and assist the team from
Austrianova, if needed, as they continue their work to produce the
necessary clinical trial material for PharmaCyte’s planned clinical
trial for LAPC.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the
necessity to be on the ground at the GMP production facility, “We are at
a very crucial point on our path to a clinical trial. The production of
our clinical trial material is vital to our success in the clinic, and
it is vital to advancing our clinical development timeline. We need the
testing of the finished cancer product to get underway. The data from
those tests should enable us to complete our Investigational New Drug
application (IND). After the changes Austrianova made to the
manufacturing process, about which we have already reported, we are back
on track. We’ll be here in Thailand overseeing the production runs that
will produce the clinical trial material PharmaCyte needs to continue
its journey to the clinic.”
Also, a film crew will be on hand to document the company’s
manufacturing process for the production of a video that will tell
PharmaCyte’s pancreatic cancer therapy story in its entirety.
As a reminder, Mr. Judd has a broad array of experience in development
of cell culture media for many primary cells and cell lines and is
particularly knowledgeable in the growth of HEK-293 cells. He has
developed manufacturing processes, cell assays, biochemical analysis,
cell culture processes and downstream recovery strategies for over 35
years, 30 of which have been with a major biotechnology company in the
United States.
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 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, store and release insulin in response
to the levels of blood sugar in the human body. PharmaCyte is exploring
the use of genetically modified liver cells, stem cells 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.
Contacts
Dr. Gerald W. Crabtree
Investor Relations:
PharmaCyte
Biotech, Inc.
Investor Relations Department
Telephone:
917.595.2856
Email: Info@PharmaCyte.com