Accueil / Communiqués / PharmaCyte Biotech Reports Completion of Crucial FDA-Required Study for Pancreatic Cancer Trial

PharmaCyte Biotech Reports Completion of Crucial FDA-Required Study for Pancreatic Cancer Trial

Monday, October 1st 2018 at 1:15pm UTC

LAGUNA HILLS, Calif.–(BUSINESS WIRE)– 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 it has successfully determined the modified site and chromosome
location of the cytochrome P450-2B1 gene in the DNA of the genetically
altered human cells known as 22P1G that will be encapsulated and used
together with the cancer prodrug ifosfamide in PharmaCyte’s upcoming
clinical trial. The cytochrome P450-2B1 gene is responsible for
producing the enzyme that activates the ifosfamide into its
cancer-killing form. The “integration site” information from this study
was another requirement requested by the FDA. The site of integration
was to be defined and included in PharmaCyte’s Investigational New Drug
Application (IND) before the start of the clinical trial for the
treatment of locally advanced, non-metastatic, inoperable pancreatic
cancer (LAPC).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “This
study answers one of the key questions that was raised in our pre-IND
meeting with the FDA. It represents the culmination of a long,
complicated and expensive series of experiments as well as
interpretation of a plethora of data that was generated over the last 12
months and is congruent with earlier data that we generated. Without
these findings, we would be unable to submit our IND to the FDA, so this
completed study moves us a significant step closer to submitting our IND
to the FDA.”

The study was an exceedingly complicated one that involved the latest
cutting-edge techniques such as Next Generation Sequencing (NGS) as well
as more classical techniques of polymerase chain reaction (PCR) analysis
and DNA sequencing. The comprehensive and voluminous set of data that
was generated from these tests was subjected to a robust and
multi-faceted analysis. In addition to providing a better
characterization of the cells at the DNA level, this analysis has
revealed that the cytochrome P450-2B1 expression construct is located on
human chromosome 9 in PharmaCyte’s 22P1G cell line. Additional analyses
have revealed that the location of the construct is in a benign region
of the human genome that should be “safe.” This supports the previous
conclusion that the 22P1G cells have a good safety profile.

The data obtained from the in-depth analyses also confirm data that has
been previously announced by PharmaCyte that concerned enzymatic assays
and Southern blotting analyses (a method used in molecular biology for
detection of specific DNA sequence in DNA samples) of the 22P1G cells.

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 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. The cell lines being
studied and developed are human liver cells, stem cells and 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 are designed to 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

PharmaCyte Biotech, Inc.
Dr. Gerald W. Crabtree, 917-595-2856
Investor
Relations Department
Info@PharmaCyte.com

Source: PharmaCyte Biotech, Inc.


Voir aussi

Poxel Reports Financial Results for Full Year 2018 and Provides Corporate Update

Thursday, March 21st 2019 at 4:45pm UTC Executed strategic agreement for Imeglimin with Roivant Sciences; …