PharmaCyte Biotech on Schedule for 2016 Cancer Clinical Trial in Pancreatic Cancer
February 24 2016 - 9:00AM
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®, issued a further update on its upcoming
clinical trial in pancreatic cancer. In this update, PharmaCyte’s
Chief Executive Officer, Kenneth L. Waggoner, clarifies statements
made earlier this week that reportedly confused numerous
shareholders and potential investors.
“Last Monday I tried to address certain issues
that shareholders and potential investors have raised repeatedly
about our upcoming clinical trial and provide an update on our
efforts to complete the process of preparing the Investigational
New Drug application (IND) that PharmaCyte must submit to the FDA
to start our clinical trial in pancreatic cancer. Given the number
of telephone calls and emails the Company has received since that
update was published, it has become apparent that the update caused
confusion and raised issues of concern that were never
intended.
“When it was stated on Monday that the expected
‘start date’ for PharmaCyte’s clinical trial in pancreatic cancer
remains difficult to announce with certainty, we were not implying
that we aren’t still on schedule to get into the clinic in 2016 or
that we don’t have any idea when we will be in the clinic. We plan
to be in the clinic well before the end of this year. It was simply
a statement that intended to refrain from announcing a specific
date or time period for starting the trial because much of what is
left to complete is out of our control.
“PharmaCyte is involved in a well-planned,
detailed and methodical process to insure that every aspect of the
IND is correct before we submit the IND to the FDA. As the
“Sponsor” of the IND, it is our responsibility to insure that the
Chemistry, Manufacturing and Controls (CMC) section of the IND is
complete and accurate in every respect. We are working with
Translational Drug Development (TD2), Chamow & Associates
(Chamow) and Austrianova in completing everything that is required.
It is a process that began last year and is well underway.
“TD2 is fully engaged and working diligently in
all aspects of preparing for the clinical trial. With respect to
developing the CMC information, the process is complicated, labor
intensive and highly technical. But with TD2 taking the lead,
working in concert with Chamow and Austrianova, I am very confident
that our schedule is on track.”
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 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 DepartmentTelephone: 917.595.2856Email:
info@PharmaCyte.com