PharmaCyte Biotech Announces Pre-IND Meeting Date with FDA
January 04 2017 - 9:25AM
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 will be meeting
with the Center for Biologics Evaluation and Research (CBER) of the
U.S. Food and Drug Administration (FDA) on Tuesday, January 17,
2017. The meeting is to discuss numerous aspects of PharmaCyte’s
planned clinical trial in locally advanced, inoperable pancreatic
cancer (LAPC).
PharmaCyte’s Chief Executive Officer, Kenneth L.
Waggoner, commenting on the meeting said, "We are pleased that
PharmaCyte will be starting out the New Year with a meeting with
CBER. PharmaCyte has submitted a list of important questions to the
FDA that will be essential to the design of our trial and how it is
to be conducted. The questions also touch on the need for any
additional information to be developed or submitted to the FDA
before PharmaCyte files its Investigational New Drug application
(IND). We are looking forward to CBER’s responses so that we can
continue with our product development of an effective and safe
therapy for LAPC.”
PharmaCyte recently submitted questions to the
FDA as part of its pre-IND submission package. With answers to
these questions and any additional information provided by CBER
during the January 17 meeting, PharmaCyte will address any open
issues or requests of CBER before preparing its IND. Once the IND
is submitted and found to be acceptable to the FDA, PharmaCyte can
proceed with its planned clinical trial in LAPC and enroll patients
at the selected trial sites throughout the U.S.
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 ifosfamide 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