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 PharmaCyte’s
consultant cellular biologist, David Judd, will be on site at
Austrianova’s GMP manufacturing facility in Bangkok, Thailand, as the
production of its clinical trial material for the treatment of locally
advanced, non-metastatic, inoperable pancreatic cancer (LAPC) is
underway.
Mr. Waggoner and Mr. Judd will observe the culturing of the genetically
altered HEK-293 cells both before and after they are encapsulated. 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. Although Mr. Judd has
already offered advice to both PharmaCyte and Austrianova via telephonic
communications, his actual on-site presence should prove to be
invaluable. Mr. Judd will lend assistance in helping correct any
unforeseen problems in the production process as the latest two
staggered manufacturing “runs” are carried out and completed.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “After
the changes to the manufacturing process allowed us to get back on track
and proceed with GMP production of the “CypCaps,” our clinical trial
product for the company’s planned clinical trial in LAPC, I felt it was
necessary to be on-site with David, our consulting expert in the culture
of HEK-293 cells, to oversee the process and ensure we are staying on
the path and clinical trial development timeline that we’ve developed to
submit our Investigational New Drug application (IND). His presence will
be particularly important since this time two manufacturing runs will be
performed in a staggered fashion rather than consecutively as has been
done in the past.”
While in Thailand, Mr. Waggoner, Mr. Judd, Prof. Dr. Walter H. Günzburg
and Dr. Brian Salmons of Austrianova and possibly others will be
interviewed on the progress of the production, the testing of the
clinical trial product, factors involved in the manufacturing process
that will be included in the submission of the IND and various other
topics related to the company’s planned clinical trial in LAPC.
While on-site at the GMP facility in Thailand, the company expects to
post pictures, videos and interviews on its social media platforms.
Shareholders and others who are interested in PharmaCyte’s content,
should follow the company’s social media platforms:
Follow PharmaCyte on Facebook at: https://www.facebook.com/PharmaCyteBiotech
Follow
PharmaCyte on Twitter at: https://twitter.com/PharmaCyte
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