PharmaCyte Biotech Requests Pre-IND Meeting with FDA for its Pancreatic Cancer Clinical Trial
November 01 2016 - 9:00AM
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage
biotechnology company focused on developing targeted treatments for
cancer and diabetes using its signature live-cell encapsulation
technology, Cell-in-a-Box®, today announced that it has submitted a
request for a pre-IND meeting with the U. S. Food and Drug
Administration (FDA) for its planned clinical trial in locally
advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte has submitted questions to the FDA as
part of a pre-IND meeting request where aspects of the content of
the Investigational New Drug (IND) application itself (CMC section,
clinical trial description, etc.) will be discussed. After the FDA
has responded to the questions and issued comments, PharmaCyte must
address them to the FDA's satisfaction. A review of PharmaCyte’s
responses by the FDA will then take place at the formal pre-IND
meeting where final agreement between PharmaCyte and the FDA on all
aspects discussed will be reached. With this information, the IND
will be submitted by PharmaCyte and reviewed by the FDA. Once the
IND is found to be acceptable to the FDA, patients can be enrolled
in PharmaCyte’s clinical trial.
PharmaCyte’s Chief Executive Officer, Kenneth L.
Waggoner, said of the meeting request, "We are pleased that
PharmaCyte has taken the first step towards regulatory approval in
the United States of its therapy for LAPC. When I started to lead
this company in January 2014, my first goal was to surround our
technology with the best of the best in the biotech sector. I
believe we have more than accomplished this goal as we have
compiled an internationally renowned team that will lead PharmaCyte
into what we expect to be a pivotal human clinical trial. My second
goal was to get our therapy to the FDA, and with this pre-IND
meeting request, we have accomplished this goal as well. My
ultimate goal, of course, was and is to get our pancreatic cancer
therapy into clinical trials and approved by the FDA. I feel we are
well on our way to accomplishing this goal.”
PharmaCyte’s clinical trial in patients with
LAPC is designed to meet a clear unmet medical need for those whose
cancer no longer responds after 4-6 months of treatment with the
combination of Abraxane® plus gemcitabine. The trial will be
open-label and multi-site in nature, with sites in the U.S. and
Europe. Patients with LAPC will be randomized equally into two
groups. One group will receive gemcitabine chemotherapy alone, and
the other group will receive PharmaCyte’s pancreatic cancer therapy
(encapsulated genetically modified live human cells that can
activate the cancer prodrug ifosfamide plus low doses of the
prodrug to eliminate side effects from the chemotherapy). In
addition to comparing the anticancer activity and safety of the two
therapies, a major aspect of the trial will be to determine if, and
how well, PharmaCyte’s therapy can shrink inoperable tumors so that
they become operable.
About PharmaCyte Biotech
PharmaCyte Biotech a clinical stage
biotechnology company developing 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. These encapsulated cells are implanted as
close to the patient’s cancerous tumor as possible. 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 comes in contact with the encapsulated cells they act as
an artificial liver and activate the chemotherapy drug at the
source of the cancer. This “targeted chemotherapy” has proven
effective and safe to use in past clinical trials and results in no
side effects.
In addition to developing a novel therapy for cancer, PharmaCyte
is developing a treatment for Type 1 diabetes and insulin-dependent
Type 2 diabetes. PharmaCyte plans to encapsulate 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 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 may contain forward-looking
statements regarding PharmaCyte Biotech and its future events and
results that involve inherent risks and uncertainties. The words
"anticipate", "believe", "estimate", "expect", "intend", "plan" and
similar expressions, as they relate to PharmaCyte or its
management, are intended to identify forward-looking statements.
Important factors, many of which are beyond the control of
PharmaCyte, could cause actual results to differ materially from
those set forth in the forward-looking statements. They include
PharmaCyte's ability to continue as a going concern, delays or
unsuccessful results in preclinical and clinical trials, flaws or
defects regarding its product candidates, changes in relevant
legislation or regulatory requirements, uncertainty of protection
of PharmaCyte’s intellectual property and PharmaCyte’s continued
ability to raise capital. PharmaCyte does not assume any obligation
to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be
found at www.PharmaCyte.com. It can also be obtained by contacting
Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com