LAGUNA HILLS, Calif.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/INDstatus?src=hash" target="_blank"gt;#INDstatuslt;/agt;–PharmaCyte
Biotech, Inc. (OTCQB: PMCB), a 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 advances have been completed in the manufacturing process for the
clinical trial product that will be used in PharmaCyte’s planned
clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
Since PharmaCyte’s last press release describing the manufacturing
process for its clinical trial product and the testing of that product,
the data from the manufacturing process has been reviewed, analyzed and
discussed in great detail among PharmaCyte’s management team, including
the leader of its clinical development program in pancreatic cancer and
designated Principal Investigator (PI) for the LAPC trial, Prof. Manuel
Hidalgo of the Harvard Medical School, Austrianova’s management team
(the manufacturer of the clinical trial product), cGMP Validation
(PharmaCyte’s cGMP expert consulting firm), Eurofins Lancaster
Laboratories (who produced the cells for PharmaCyte’s Master Cell Bank)
and several consulting cellular biologists.
The data obtained to date from the encapsulation parameters of the
manufacturing process itself indicate that the encapsulation portion of
the process is fault free and reproducible, which is a fundamental
requirement of the FDA.
On the advice of PharmaCyte’s cGMP expert, the company plans to conduct
two additional and staggered manufacturing runs in order to maximize the
chances for a successful IND submission given the novelty and complexity
of the entire process. In the time since the last manufacturing run,
which we reported on in January of this year, those involved with the
manufacturing process have been concentrating on changes that can be
made to improve the process. We believe that these changes will improve
the cGMP manufacturing process to the point that the entire process can
be shown to be consistently reproducible and robust as required by the
FDA, and to ensure that the end-products of these manufacturing runs
will convert the cancer prodrug ifosfamide into its cancer-killing form
as well as they should.
This intensive effort has involved several independent tests by
Austrianova and Eurofins. The results of these tests strongly indicate
that, after the suggested changes are implemented, positive results
should be obtained. When the changes are made to the cGMP manufacturing
process, they should significantly improve the growth of the cells
obtained from the Master Cell Bank both before and after encapsulation
takes place. PharmaCyte and Austrianova and its team of consultants are
in the final stages of optimizing this aspect of the manufacturing
process.
Meanwhile, PharmaCyte’s clinical development program in pancreatic
cancer is progressing. As explained by Prof. Hidalgo, “PharmaCyte has a
strong clinical trial program for pancreatic cancer. The trial design
has been thoroughly vetted by a team of the best pancreatic cancer
specialists in the country. I continue to lead PharmaCyte’s program in
pancreatic cancer, and I am eager to get underway as its PI for the LAPC
trial. Members of PharmaCyte’s team are working on various aspects of
implementing the program. I remain excited about the potential that
PharmaCyte’s technology can offer patients who are suffering from LAPC
and am looking forward to what a successful trial may mean for the way
some types of solid cancerous tumors are treated in the future.”
About PharmaCyte Biotech
PharmaCyte Biotech is a 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 reportedly 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 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 may contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that
express the current beliefs and expectations of the management of
PharmaCyte Biotech, including statements regarding the timing and
commencement of our first Phase 2b clinical trial. Any statements
contained herein that do not describe historical facts are
forward-looking statements that are subject to risks and uncertainties
that could cause actual results, performance and achievements to differ
materially from those discussed in such forward-looking statements.
Factors that could affect our actual results are included in the
periodic reports on Form 10-K and Form 10-Q that we file with the
Securities and Exchange Commission. These forward-looking statements are
made only as of the date hereof, and we undertake no obligation to
update or revise the forward-looking statements, except as otherwise
required by law, whether as a result of new information, future events
or otherwise
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
PharmaCyte Biotech, Inc.
Investor
Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com