PharmaCyte Biotech Designs Clinical Trial to Meet Critical Unmet Medical Need
October 14 2015 - 8:25AM
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 upcoming
clinical trial will determine whether its pancreatic cancer
treatment (Cell-in-a-Box® capsules + low-doses of ifosfamide) can
satisfy a critical unmet medical need for patients with pancreatic
cancer when the “gold standard” treatment is no longer effective at
treating the disease. Currently there is no adequate alternative
treatment available.
Translational Drug Development (TD2), along with
Dr. Matthias Löhr of the famed Karolinska Institute in Stockholm,
Sweden, and the Chairman of PharmaCyte Biotech’s Scientific
Advisory Board, and Dr. Manuel Hidalgo, the Director of Clinical
Research at the Spanish National Cancer Research Center and a
member of PharmaCyte’s Scientific Advisory Board, provided
invaluable information and guidance to PharmaCyte in the design of
its clinical trial in advanced pancreatic cancer. The trial is
designed to provide an effective treatment for the large percentage
of patients who no longer respond to the “gold standard” for the
treatment of advanced pancreatic cancer. There are few options for
further treatment available to them, and these are only marginally
effective. PharmaCyte’s team believes that it is here that
PharmaCyte’s pancreatic cancer treatment could play an important
role in what has been termed a “consolidation therapy” in the
further treatment of these patients.
As previously explained by Dr. Löhr in his
recent article on the unmet medical need being targeted by
PharmaCyte, chemotherapy may be able to prevent relapse in patients
whose pancreatic cancer tumors have been removed surgically, but
this situation occurs in only 20% of all patients at best. The
large remaining group of patients whose tumors are inoperable
normally receive treatment designed to prolong survival. Recent
progress in the chemotherapy of pancreatic cancer has resulted in
survival rates of between 10 and 11 months through the use of
either the combination of gemcitabine and nab-paclitaxel
(Abraxane®), the “gold standard” for the treatment of pancreatic
cancer, or a harsh combination of conventional cancer chemotherapy
drugs known as FOLFIRINOX that not all patients can tolerate.
However, for patients whose tumors neither
progress nor show signs of tumor reduction, there is no effective
treatment alternative. PharmaCyte’s treatment of pancreatic cancer
may fill this critical unmet medical need for these patients. This
need and opportunity caused PharmaCyte to completely redesign its
clinical trial.
In addition to examining the antitumor
effectiveness of PharmaCyte’s pancreatic cancer treatment, the
effect of the treatment on the development and progression of the
pain associated with pancreatic cancer will also be measured in the
clinical trial. Because this “pain” aspect will be studied, it will
no longer be necessary to conduct a separate “pain” clinical trial
as originally planned. The pain associated with pancreatic cancer
is both unbearable and untreatable in about 25% of patients with
the disease.
PharmaCyte Biotech’s Chief Executive Officer,
Kenneth L. Waggoner, commented, “We are extremely grateful to TD2,
Dr. Löhr and Dr. Hidalgo for their insight and guidance in
designing our clinical trial. We believe that their identification
of the opportunity for our pancreatic cancer treatment to satisfy a
critical unmet medical need will give our pancreatic cancer
treatment the greatest opportunity for success. The inclusion of
the previously planned separate pain trial in the upcoming trial
will also eliminate the need for a costly and time-consuming
separate trial to study this aspect of our pancreatic cancer
treatment. Over the next week or so, we will be laying out our new
trial design and the other changes related to the upcoming clinical
trial.”
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 Biotech’s treatment for cancer
involves encapsulating genetically modified live cells capable of
converting 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 Biotech is developing a treatment for Type 1
diabetes and Type 2 insulin-dependent diabetes. PharmaCyte Biotech
plans to encapsulate a human cell line which has been genetically
engineered to produce, store and secrete insulin at levels in
proportion 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 Biotech or its
management, are intended to identify forward-looking statements.
Important factors, many of which are beyond the control of
PharmaCyte Biotech, 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 Biotech’s intellectual property and PharmaCyte
Biotech’s continued ability to raise capital. PharmaCyte Biotech
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