PharmaCyte Biotech Issues Update on Preparations for Its Pancreatic Cancer Clinical Trial
February 22 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®, issued an update on its efforts to get
PharmaCyte’s pancreatic cancer treatment into a Phase 2b clinical
trial. In the update PharmaCyte’s Chief Executive Officer, Kenneth
L. Waggoner, explains why the expected ‘start date’ for
PharmaCyte’s clinical trial in pancreatic cancer remains difficult
to announce with certainty and addresses a number of issues that
PharmaCyte’s shareholders have raised related to the upcoming
clinical trial.
“First and foremost, there is the issue of the
redesign of the clinical trial in pancreatic cancer. As our
longtime investors are aware, the clinical trial was originally
designed to compare our pancreatic cancer treatment ‘head to head’
with the combination of Abraxane® + gemcitabine in patients with
advanced, inoperable pancreatic cancer. When the Abraxane® +
gemcitabine combination was approved by the FDA (after an 861
patient trial that took Celgene several years to complete) and
later became the ‘gold standard’ of care for advanced pancreatic
cancer worldwide, it became obvious that the original trial design
was no longer feasible. Getting patients to enroll in the trial
would have been very problematic. Understandably, we felt patients
with pancreatic cancer would opt for the new ‘gold standard’ of
care rather than enrolling in a clinical trial to prove that
PharmaCyte’s treatment is superior to the gold standard. In
addition, to prove success the originally designed trial would have
involved hundreds of patients, taken years to complete and would
have been so expensive to conduct that only “big pharma” could have
afforded to carry it out successfully.
“With invaluable input from three of the world’s
leading authorities in pancreatic cancer, the trial was completely
redesigned to what it is today. We continue to improve the design
with the hope that it will result in the best possible outcome for
pancreatic cancer patients and that PharmaCyte’s treatment will
become a recognized treatment for a significant segment of those
with pancreatic cancer. In the newly designed trial, PharmaCyte’s
pancreatic cancer treatment will be compared against the best
available therapy (the combination of chemotherapy drug
capecitabine + radiation) in patients whose pancreatic cancer no
longer responds to either the Abraxane® + gemcitabine combination
or a 4-drug combination known as FOLFIRINOX. Adding FOLFIRINOX to
the inclusion criteria is a new element and expands the potential
patient population that will be available to participate in the
trial. These therapies are by far the most widely used around the
world to treat advanced, inoperable pancreatic cancer. Patients in
our trial will have tumors that are locally advanced (they have not
spread to different organs in the body), but nevertheless are
inoperable. Instead of conducting the trial in just Australia, as
was proposed in the original trial design, we plan to conduct the
trial in the United States with study sites in Europe and
Australia.
“In addition to the direct effects of the
comparator treatment on the growth of a patient’s cancerous tumor,
measurements will be taken to determine if our treatment can
convert an inoperable tumor to an operable one, which the
capecitabine + radiation combination cannot do well, if at all. If
our treatment is successful in doing so, imagine what that would
mean to the numerous patients around the world who suffer from this
dreadful and deadly disease and to their prospects for a
significantly increased lifespan. The new trial design also
eliminates the need for a separate clinical trial on the effects of
our pancreatic cancer treatment on the unbearable and untreatable
pain that is associated with pancreatic cancer in 20-25% of
patients. In the new trial design, measurements that will ‘track’ a
patient’s pain and a patient’s need for pain medication have been
incorporated into the trial.
“Needless to say, the redesign of the entire
clinical trial was labor intensive and took many months to
complete. All three of our world-renowned pancreatic cancer experts
agree enthusiastically with the new trial design and believe that
it provides PharmaCyte with the opportunity to satisfy a clear
unmet medical need by providing a large number of pancreatic cancer
patients with a successful treatment option that does not exist
today. They also believe that the trial can be conducted with far
fewer patients, take less time and cost a great deal less money to
complete than the trial that was originally designed might have
cost PharmaCyte.”
Waggoner continued, “Second, there is the issue
of ensuring that the manufacturing facility that Austrianova has
built in Bangkok, Thailand, which encapsulate the live cells that
convert the cancer prodrug ifosfamide into its cancer-killing form,
meets current Good Manufacturing Practices (cGMP) standards. This
is an absolute requirement for drug regulatory authorities around
the world before a clinical trial can begin. All aspects of the
construction of the facility need to be qualified, validated and
documented, as does every item used within the facility. Numerous
‘standard operating procedures’ must also be written, inspected for
quality and clarity and retained for future use. Test ‘runs’ of the
encapsulation process must also be qualified and validated. Even
the employees who work in the facility must meet stringent
regulations. Literally ‘volumes’ of documentation result from these
activities. This work is extremely labor intensive and
time-consuming, but is currently being accomplished by our
colleagues at Austrianova.
“The process to assure that Austrianova’s
live-cell encapsulation facility meets cGMP standards is well
underway. After Chamow & Associates (Chamow) inspected the
facility in December 2015, they prepared a detailed audit report
for Austrianova to use as a blueprint to complete the work
necessary to insure that the facility is cGMP compliant. Twice
monthly PharmaCyte, Translational Drug Development (TD2), Chamow
and Austrianova hold a lengthy teleconference to discuss the
progress that is being made in completing the items necessary for
the facility to become cGMP compliant and in generating the bulk of
the CMC information needed for the Investigational New Drug
application (IND) we plan to submit to the FDA. A detailed Gantt
chart has been prepared to monitor the progress being made and to
assist in keeping the project on schedule.
“Evidence of the cGMP compliance of the
encapsulation facility must be presented to drug regulatory
authorities as part of the Chemistry, Manufacturing and Controls
(CMC) section of the IND. It must be deemed satisfactory by the FDA
before the clinical trial can begin. The cGMP facility information
makes up the bulk of the CMC information package, which, in turn,
makes up the largest and arguably the most important part of the
IND. PharmaCyte is very fortunate to have retained Chamow, an
outstanding biopharmaceutical consulting firm, that specializes in
the inspection of facilities for cGMP compliance and in the
preparation of the CMC section of INDs. Chamow is working in
concert with TD2 to prepare the CMC section of our IND for the
facility in Thailand.”
About PharmaCyte Biotech
PharmaCyte 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 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, a chemotherapy drug which
needs to be activated in the body (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 the ifosfamide, which is normally activated
in the liver, comes in contact with the encapsulated live cells,
activation of the chemotherapy 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 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