PharmaCyte Biotech Submits Pre-IND Meeting Package to FDA
December 15 2016 - 9:47AM
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®, announced today that it has submitted
its pre-Investigational New Drug (pre-IND) meeting package to
the U.S. Food and Drug Administration (FDA) for
PharmaCyte’s therapy in inoperable locally advanced pancreatic
cancer (LAPC). PharmaCyte’s pre-IND submission follows
its recent announcement that the FDA has granted
PharmaCyte a pre-IND meeting for its pancreatic cancer therapy.
The package provides the FDA with a full history of
PharmaCyte’s therapy, including information on the previous
preclinical studies and the clinical trials that were performed
using the Cell-in-a-Box® live-cell encapsulation technology
combined with low doses of the chemotherapy drug ifosfamide. That
combination makes up PharmaCyte’s pancreatic cancer therapy. The
package also provides detailed information on the manufacturing
process used to produce the Cell-in-a-Box® capsules and a synopsis
of the structure of the clinical trial that PharmaCyte plans to
conduct in the U.S. and Europe in patients with inoperable
LAPC.
The FDA’s response to the pre-IND submission will be
provided after the pre-IND meeting. The regulatory agency’s
response will serve as a roadmap in guiding PharmaCyte as it
prepares the full IND application that must be deemed acceptable to
the FDA before the clinical trial can begin.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner,
commented, “The submission of the pre-IND package is yet another
major step that PharmaCyte has completed in its efforts to develop
its pancreatic cancer therapy. We are looking forward to the
pre-IND meeting and the FDA’s guidance as we prepare for our
clinical trial in patients with inoperable LAPC where there is an
unmet medical need we plan to address.”
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