PharmaCyte Executives Meet With Translational Drug Development to Advance Pancreatic Cancer Clinical Trial
January 25 2016 - 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®, announced today that its Chief
Executive Officer, Kenneth L. Waggoner, and its Chief Operating
Officer, Dr. Gerald W. Crabtree, recently met with principals of
Translational Drug Development (TD2) at TD2’s facilities in
Scottsdale, Arizona. The meeting was held to discuss a number of
aspects related to PharmaCyte’s upcoming clinical trial in
pancreatic cancer and the structure of the Investigational New Drug
Application (IND) that must be submitted to the FDA and found
acceptable before the clinical trial can begin. PharmaCyte has
contracted with TD2 to be the lead Contract Research Organization
(CRO) to prepare for and conduct PharmaCyte’s clinical trial in
pancreatic cancer.
In its clinical trial, PharmaCyte’s pancreatic
cancer treatment (microcapsules containing live cells that convert
the cancer prodrug ifosfamide into its cancer-killing form together
with low doses of ifosfamide) will be compared with the combination
of the cancer drug capecitabine plus radiation therapy. The
clinical trial will be an open-label, “two-armed,” randomized
multi-site trial.
The morning session addressed how the clinical
trial will be structured and conducted. It was determined that
there will be several cancer centers in the United States, with a
number of study sites in Europe and possibly Australia. Discussions
also dealt with suggested changes related to the number of patients
in each arm of the trial, inclusion/exclusion criteria for patients
that will be enrolled in the trial and possible sites at which the
trial will be conducted.
The afternoon session focused on the IND and the
timeline for filing it with the FDA. The afternoon session also
included discussions related to the content and preparation of the
Chemistry, Manufacturing and Controls (CMC) section of the IND. The
CMC section is a pivotal part of the IND and will be a major focus
of the FDA when it examines PharmaCyte’s IND submission. TD2 and
Chamow & Associates (Chamow) will both prepare the CMC section
of the application. Chamow has already performed an inspection and
audit of Austrianova’s live-cell encapsulation facility in Bangkok,
Thailand. That is the facility where the genetically modified live
cells will be encapsulated using the Cell-in-a-Box® technology that
are part of PharmaCyte’s pancreatic cancer treatment.
In commenting on the sessions at TD2, Waggoner
stated, “These face-to-face meetings with TD2’s clinical trial team
were extremely important and exceedingly helpful to PharmaCyte in
finalizing the design of the clinical trial. We believe they will
prove to be invaluable as we move forward with the preparations for
our upcoming clinical trial in pancreatic cancer. The interactions
that we had with the team at TD2 in this one day alone reinforce
our belief that, in TD2, we have the finest CRO available in which
to put our trust that PharmaCyte’s clinical trial will be prepared
and conducted as well as it could be.”
About PharmaCyte
BiotechPharmaCyte Biotech is a clinical stage
biotechnology company focused on developing and preparing to
commercialize treatments for cancer and diabetes based upon a
proprietary cellulose-based live cell encapsulation technology
known as “Cell-in-a-Box®.” This unique and patented technology will
be used as a platform upon which treatments for several types of
cancer and diabetes are being developed.
PharmaCyte’s treatment for cancer involves
encapsulating genetically modified live cells that convert an
inactive chemotherapy drug (ifosfamide) into its active or
“cancer-killing” form. These encapsulated live cells are placed as
close to a cancerous tumor as possible. Once implanted in a
patient, ifosfamide is then given intravenously at one-third the
normal dose. The ifosfamide is carried by the circulatory system to
where the encapsulated cells have been placed. When ifosfamide,
which is normally activated in the liver, comes in contact with the
encapsulated live cells, activation of the drug takes place at the
source of the cancer without any side effects from the
chemotherapy. This “targeted chemotherapy” has proven remarkably
effective and safe to use in past clinical trials.
In addition to developing a novel treatment for
cancer, PharmaCyte is developing a treatment for Type 1 diabetes
and Type 2 insulin-dependent 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.
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 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