PharmaCyte Biotech Finalizes Design of Pancreatic Cancer Clinical Trial and Identifies Trial Sites under Consideration
March 31 2016 - 9:20AM
PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage
biotechnology company focused on developing targeted therapies for
cancer and diabetes using its live-cell encapsulation technology,
Cell-in-a-Box®, today announced the final design of its clinical
trial for patients with advanced pancreatic cancer. The clinical
trial design was developed with Translational Drug Development
(TD2), America’s premier oncology Contract Research Organization,
as well as with renowned pancreatic cancer specialists consulting
with PharmaCyte.
PharmaCyte’s Chief Executive Officer, Kenneth L.
Waggoner, stated, “The trial is designed to determine if
PharmaCyte’s pancreatic cancer treatment (the combination of
micro-capsules that contain genetically modified human cells which
convert the cancer prodrug ifosfamide into its “cancer-killing”
form at one-third the normal dose) can satisfy a clear unmet
medical need that exists for patients with locally advanced,
inoperable pancreatic cancer who no longer respond to the current
standard of care. Most of these patients are initially treated with
the combination of nab-paclitaxel (Abraxane®) plus gemcitabine or
the four-drug combination known as FOLFIRINOX. When these patients’
tumors no longer respond to treatment with these regimens, the next
standard of care offers little to no benefit. It is then that these
patients are often treated with the combination of the anticancer
drug capecitabine plus radiation therapy. However, this combination
is only marginally effective in stopping the progression of the
disease. In PharmaCyte’s clinical trial, our pancreatic cancer
therapy will be compared “head to head” with the
capecitabine/radiation combination to demonstrate that it is
clearly superior in treating these patients while maintaining a
superior quality of life during the therapy.”
Major factors in the overall trial design
are:
- The clinical trial will be international (United States, Europe
and possibly Australia), multi-site, open-label and
randomized.
- Study sites under consideration in the United States include
the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess
Cancer Center and the Dana-Farber Cancer Institute both in Boston,
Massachusetts, the Baylor Cancer Center in Dallas, Texas, the City
of Hope Cancer Center in Los Angeles, California, and sites in
Germany and Spain.
- The randomization ratio of patients between the two study
groups will be 1:1 (an equal number of patients will be randomly
assigned to the capecitabine + radiation group and the PharmaCyte
pancreatic cancer therapy group).
- As many as 84 patients will be required to complete the study,
although fewer may be required based upon the data developed during
the trial.
- Only patients who have locally advanced, non-metastatic,
inoperable cancers and whose tumors no longer respond after 4-6
months of treatment with either the nab-paclitaxel (Abraxane®) +
gemcitabine or FOLFIRINOX regimens will be eligible for the
study.
- Unlike the earlier clinical trials using PharmaCyte’s
pancreatic cancer therapy where patients received only two doses of
ifosfamide, multiple cycles of ifosfamide will be given to those
being treated with PharmaCyte’s pancreatic cancer therapy. This
will continue until the patients’ tumors no longer respond to
PharmaCyte’s therapy or until treatment-related toxicity
accumulates to unacceptable levels.
Mr. Waggoner concluded, “We feel that the major
factors that needed to be considered for the development of a
complete clinical trial protocol have now been addressed. Of
course, as we continue to move toward our clinical trial, slight
changes that benefit the overall trial design could certainly be
addressed and lead to further refinement of the trial. Special
appreciation for reaching this point must be given to the renowned
pancreatic cancer experts who have played such a major role in the
trial design. With these developments, we are yet another step
closer to the commencement of our clinical trial which we believe
will satisfy the clear unmet medical need experienced by patients
with locally advanced, but inoperable, pancreatic cancer who no
longer respond to the gold standard of care.”
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 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 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