PharmaCyte Biotech Selects Dr. Manuel Hidalgo as Principal Investigator for Its Pancreatic Cancer Clinical Trial
October 24 2016 - 8:00AM
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 Manuel Hidalgo,
MD, PhD has agreed to serve as the Principal Investigator (PI) for
PharmaCyte’s clinical trial in patients with locally advanced,
inoperable pancreatic cancer (LAPC). Dr. Hidalgo is an
internationally respected oncologist and a recognized authority in
the treatment of pancreatic cancer. Currently, he serves as
Clinical Director of the Leon V. & Marilyn L. Rosenberg
Clinical Cancer Center and Chief of the Division of
Hematology-Oncology at the prestigious Beth Israel Deaconess
Medical Center in Boston and is a member of PharmaCyte’s Medical
and Scientific Advisory Board.
Commenting on his selection, Dr. Hidalgo said,
“I am pleased to have been selected to be the PI of this important
clinical trial, having been a part of its overall design. I have
been involved in numerous successful clinical trials and will be
drawing on that experience in this one. I believe that the
Cell-in-Box® plus low dose ifosfamide combination chemotherapy may
well prove to be of great value for the development of new
therapies for pancreas and other solid tumor cancers. This novel
technology has exceedingly broad application. I am looking forward
to working with other clinical oncologists in the U.S. and in
Europe to insure that PharmaCyte’s therapy meets the critical unmet
medical need the study is designed to address.”
PharmaCyte’s Chief Executive Officer, Kenneth L.
Waggoner, also commented, “As we close in on an engagement date
with the FDA, we are extremely pleased and fortunate that Dr.
Hidalgo has agreed to assume the important position of PI for our
clinical trial in patients with LAPC. The available treatments of
this disease are only marginally effective. Dr. Hidalgo is well
known around the world as an expert in successfully developing
therapies for pancreatic cancer, the third deadliest of all forms
of cancer. Dr. Hidalgo’s acceptance of the role of PI for our
clinical trial lends credence to our belief that PharmaCyte’s
therapy will be successful in treating patients with LAPC.”
In his role as PI, or “general supervisor” for
how the trial is conducted, Dr. Hidalgo will be responsible for
ensuring that all of the clinical trial study sites conduct their
studies in accordance with the clinical trial protocol and that all
associated procedures and regulations are followed by those study
sites. As PI, Dr. Hidalgo will also play a major role in developing
the final clinical trial report that will be presented to the FDA,
which summarizes and analyzes the trial results from all of the
study sites.
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 study 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 an “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