PharmaCyte Biotech Retains Facet Life Sciences to Guide Pancreatic Cancer Therapy Development Lifecycle with FDA
31 January 2017 - 1:00AM
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®, officially announced today that
PharmaCyte has retained Facet Life Sciences, Inc. (Facet) to guide
PharmaCyte through its pancreatic cancer therapy development
lifecycle with the U.S. Food and Drug Administration (FDA). Facet
has been working with PharmaCyte and Translational Drug Development
(TD2) since September 2016 and was instrumental in expediting
PharmaCyte’s pre-IND meeting with the FDA.
The Chief Executive Officer of PharmaCyte
explained retention of Facet, “After we completed much of the
Chemistry, Manufacturing and Control (CMC) work for PharmaCyte’s
pre-IND submission to the FDA, we decided that PharmaCyte needed to
retain a life sciences consulting firm that could guide it in a
broad spectrum of areas that will be required for the successful
development of PharmaCyte’s therapy for pancreatic cancer.
“Facet’s initial efforts to date have included
assembling all of the preclinical and clinical data available on
PharmaCyte’s therapy for pancreatic cancer and submission to the
FDA as a ‘pre-IND package.’ Subsequently, Facet made arrangements
with the FDA for the pre-IND meeting with the FDA and played a
significant role in the meeting. We are extremely pleased with
Facet’s performance and are convinced, based upon the results of
the FDA meeting, that we made the right selection in retaining
Facet.”
The Facet Life Sciences team is comprised of
drug development, regulatory affairs and regulatory writing experts
who have scientific degrees and over 100 years of combined
experience in the pharmaceutical, biologics, biopharmaceutical and
medical device industry. The services offered by Facet span the
full spectrum of services that PharmaCyte will need for regulatory
approval of its therapy for pancreatic cancer. Facet is the U.S.
Agent for PharmaCyte before the FDA and will assist with regulatory
and clinical strategy, preparation and support for regulatory
meetings, regulatory submission leadership, gap analyses, product
labeling, risk management and medical writing in a number of
areas.
The President and CEO of Facet, Ken VanLuvanee,
commented on Facet’s retention by PharmaCyte saying, “We are
extremely pleased to have been selected to work with PharmaCyte on
its novel live-cell encapsulation therapy for pancreatic cancer.
This is cutting edge technology that presents one of the most
complex regulatory product candidates on which we have ever worked.
In spite of its complexity, when compared to a single chemotherapy
drug for example, we believe that successful development of
PharmaCyte’s therapy may change the way tumors of the pancreas and
other solid tumors are treated in the future. It’s truly an
exciting time for us and PharmaCyte alike.”
Facet development experts work closely with
client teams to successfully reach their corporate and product
goals. Facet has created and managed critical development aspects
for some of the industry’s fastest growing life sciences companies.
Its specialists deliver expert services and cutting-edge
technologies that are designed to help small life science companies
with big goals optimize their product research and development
efforts.
About PharmaCyte Biotech
PharmaCyte Biotech is 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 little or no
side effects.
In addition to developing a novel therapy for
cancer, PharmaCyte is developing a therapy 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 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 studies 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 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