LAGUNA HILLS, Calif. -- (Business Wire)
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 the cells it will encapsulate and then use in its planned clinical
trial in patients with locally advanced, non-metastatic, inoperable
pancreatic cancer (LAPC) have successfully passed all 29 tests required
by the U.S. Food and Drug Administration (FDA). Most of the tests were
conducted by PharmaCyte’s contractor, Eurofins Lancaster Laboratories,
Inc. (Eurofins). The rest of the tests were conducted by third party
laboratories subcontracted by Eurofins.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented,
“We are pleased that the cells being used in our LAPC trial have now
successfully passed all of the rigorous and extensive testing done on
them by Eurofins and its subcontractors. The nature of the various tests
was quite varied and some of the tests were more complex than others, so
we’re excited that the cells, which are at the heart of our pancreatic
cancer therapy, could endure such a wide range of testing and pass each
and every one. Now that testing is complete and all results are
positive, we have been advised by Eurofins that we will have a final
Certificate of Analysis next week. With this document in hand, the cell
encapsulation process can begin."
Before any tests could be started, cells from the Master Cell Bank had
to be thawed from frozen storage and then cultured to obtain enough
cells for all of the planned tests. This was completed on January 24,
2018. In all, the cells underwent 29 different tests. Because of
processes involved at Eurofins pertaining to the tests, not all tests
could begin at the same time.
Once each test was completed, the test results had to be analysed and a
report written by Eurofins. Then the conduct and results of each test
had to examined and approved by Eurofins’ Quality Assurance/Quality
Control department. Now that all the tests have been successfully
completed, Eurofins is preparing the necessary Certificate of Analysis
to be sent to Austrianova in Thailand where encapsulation will be
performed using PharmaCyte’s signature live-cellencapsulation
technology. Having the Certificate of Analysis is a cGMP requirement
before encapsulation can begin.
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
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 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 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.
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
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com.
Information may also be obtained by contacting PharmaCyte’s Investor
View source version on businesswire.com: https://www.businesswire.com/news/home/20180516005682/en/
PharmaCyte Biotech, Inc.
Dr. Gerald W. Crabtree
Source: PharmaCyte Biotech, Inc.
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