PharmaCyte Biotech Granted FDA Pre-IND Meeting for Pancreatic Cancer Therapy
November 29 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 a
Pre-Investigational New Drug (Pre-IND) meeting with the Center for
Biologics Evaluation and Research (CBER) of the U.S. Food and Drug
Administration (FDA) has been granted by the FDA. During the
meeting with representatives from CBER, they will respond to
PharmaCyte’s previously submitted questions to the FDA as part of a
Pre-IND information package related to PharmaCyte’s clinical trial
in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte will be submitting a full Pre-IND
package of information to the FDA that describes what PharmaCyte
intends on submitting in its Investigational New Drug (IND)
application. The FDA will review PharmaCyte’s manufacturing,
preclinical pharmacology and toxicology and clinical trial plans
for the company’s therapy to treat LAPC. After the FDA has
responded to the questions and issued comments, PharmaCyte will
undertake steps to address them to the FDA's satisfaction which
will lead directly to the preparation of the IND application
itself. Once the IND application 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, commented about the Pre-IND meeting saying, "We are
pleased that the FDA has granted us a Pre-IND meeting in connection
with our planned clinical trial for LAPC patients whose disease has
already received maximum response from the gold standard of care -
the combination therapy of Abraxane® plus gemcitabine. Our Pre-IND
meeting is the next step in getting our pancreatic cancer therapy
into a clinical trial and approved by the FDA. We believe
PharmaCyte is well on its 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 may 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