LAGUNA HILLS, Calif.–(BUSINESS WIRE)–PharmaCyte
Biotech, Inc.(OTCQB: PMCB), a biotechnology company focused on
developing targeted cellular therapies for cancer and diabetes using its
encapsulation technology, Cell-in-a-Box®, today announced
that it has engaged cGMP Validation L.L.C. (cGMP Validation) to assist
in the preparation of the Investigational New Drug application (IND)
that must be submitted to and approved by the U.S. Food and Drug
Administration (FDA) before PharmaCyte can begin its planned clinical
trial in patients with locally advanced, non-metastatic, inoperable
pancreatic cancer (LAPC).
cGMP Validation is playing a pivotal role for PharmaCyte and will
continue to do so as it moves forward with the preparation of its IND.
The role of cGMP Validation and its President and Chief Executive
Officer, Jesse Gillikin, in particular, is to ensure that each and every
step of the manufacturing process of PharmaCyte’s encapsulated cells
completely complies with the FDA’s cGMP regulations and all other FDA
requirements requested by the U.S. drug regulatory agency. In addition
to ensuring that PharmaCyte’s clinical trial product meets regulatory
compliance throughout the production process, cGMP Validation will also
serve as a resource to Austrianova in its manufacturing process related
to cGMP requirements with which it must adhere. For example, cGMP
Validation will examine cGMP required documents prepared by Austrianova
that concern all “production runs” of the manufacturing process and work
with Austrianova to ensure compliance in every respect.
cGMP Validation will also serve, on behalf of PharmaCyte, as the agent
for the “release” of the final product that will be implanted into
patients before the chemotherapy prodrug ifosfamide is given during the
planned clinical trial in LAPC.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented,
“We are extremely fortunate to have been able to retain cGMP Validation
as our outside cGMP compliance/validation expert and to have Mr.
Gillikin work directly with us and the principals at Austrianova to make
certain that the very important manufacturing portion of our IND is
complete and compliant with the FDA’s stringent cGMP regulations.
As I mentioned in an interview last summer, we’re almost there. Our
checklist of items to be completed has been whittled down to just a few
remaining items, and cGMP Validation provides us with the confidence
moving forward to get across the finish line. It is imperative that our
submission of the IND to the FDA is done flawlessly; therefore, cGMP
Validation’s efforts will play a major role in ensuring that the IND we
plan to submit to the FDA is as complete and accurate as possible.”
cGMP Validation was established in 1997 as a full-service
validation/compliance firm offering services for the pharmaceutical,
biotechnology, biologics, medical device and medical diagnostic sectors.
It has served new and repeat clients across the U.S., Puerto Rico and
Canada and has international experience in Europe, Egypt, Korea,
Indonesia and Vietnam. cGMP is headquartered in North Carolina, and it
has an operational office in Missouri.
Mr. Gillikin is a co-founder of cGMP Validation and serves as its
President and Chief Executive Officer. He has been in the pharmaceutical
industry since 1978 and has experience in validation, managing QC
laboratories, field auditing, and compliance, including interactions
with the FDA and international regulatory agencies. His experience has
included working with numerous companies in establishing validation and
compliance practices. Mr. Gillikin’s experience enables him to provide
clients with a wide array of validation resources, such as manufacturing
equipment validation, process validation, cleaning validation and
computer validation. His extensive work with other companies, as well as
his long-standing relationship and experience with the FDA, also enables
him to provide auditing, compliance/validation program building and the
writing/execution of validation protocols.
Because of the intense efforts that PharmaCyte, cGMP Validation, and
PharmaCyte’s clinical team of consultants are currently engaged in with
respect to the preparation of the IND, as well as difficulty in
coordinating and scheduling travel with everyone involved during the
holiday season, PharmaCyte has decided to postpone its planned
shareholder meeting until the first quarter of 2019.
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
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 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.
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
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com.
Information may also be obtained by contacting PharmaCyte’s Investor