PharmaCyte Biotech Provides Update on Malignant Ascites and New Colon Cancer Studies
December 07 2015 - 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®, today issued an update on the
preclinical studies that are designed to determine the
effectiveness of the Cell-in-a-Box® plus ifosfamide therapy in
delaying the accumulation of malignant ascites fluid in the abdomen
of mice with abdominal tumors. Each of the preclinical studies in
ascites are being conducted by Translational Drug Development (TD2)
- the premier CRO in the United States specializing in
oncology. TD2 is also the CRO conducting PharmaCyte’s
upcoming clinical trial in advanced pancreatic cancer.
PharmaCyte’s initial series of preclinical
studies were done with mice that had been inoculated with a human
ovarian cancer. This tumor type grows aggressively and is prolific
in producing malignant ascites fluid. The data obtained from these
studies provided information that is being used as a foundation for
future studies on other tumor types. In the earlier preclinical
studies, the effects of varying the number of Cell-in-a-Box®
capsules and the amount of ifosfamide on mouse survival and on the
production of malignant ascites fluid were studied. The results
from this initial series of studies are now being used in
connection with new colon cancer studies that may prove to be
effective in developing a treatment that delays the production of
malignant ascites fluid in cancer patients.
In part because colon cancer is the most
commonly diagnosed cancer of the digestive tract, a new preclinical
study has just begun in mice that have been inoculated with the
regularly used Colon 26 mouse model. This new study is based upon
the results of previous work using this same model system that was
performed by Dr. Matthias Löhr, the Chairman of PharmaCyte’s
Scientific Advisory Board, and his colleagues at the University of
Heidelberg, Germany. The results of the previous study were
reported in the scientific publication Cancer Gene Therapy in 2006.
This publication can be viewed at
http://www.nature.com/cgt/journal/v13/n1/full/7700849a.html.
The results of the study performed by Dr. Löhr
demonstrated that the intraperitoneal administration of a
combination of the Cell-in-a-Box® capsules (then known as CapCell®)
and ifosfamide was effective in treating the spread of colon cancer
that was caused by malignant ascites fluid. It is believed that the
new “Colon 26” study being conducted at TD2 will serve to verify
the results of the previous work and provide additional information
on how best to use the intraperitoneal administration of the
combination of Cell-in-a-Box® capsules and ifosfamide to control
the spread of colon cancer from malignant ascites fluid as well as
the production of malignant ascites fluid.
The Chief Executive Officer of PharmaCyte,
Kenneth L. Waggoner, commented, “Through the use of different
animal model systems such as the ES-2 for ovarian cancer and the
Colon 26 model for colon cancer, we believe that we will be able to
better define the parameters by which the combination of the
Cell-in-a-Box® capsules and ifosfamide is most effective in
controlling the production of malignant ascites fluid brought on by
abdominal cancers. If we are successful in our endeavors,
PharmaCyte will have developed a treatment that will help combat
the spread of abdominal tumors and reduce the suffering of cancer
patients from the accumulation of ascites fluid within the
abdominal cavity.”
Malignant ascites fluid is produced by abdominal
cancers, such as colon, ovarian, stomach, intestine, pancreas and
uterus. It is this fluid that is responsible, in large part, for
the spread of cancer cells from the original tumor to other sites
in the peritoneal cavity. The accumulation of ascites fluid is
extremely problematic. In the case of pancreatic cancer, large
volumes of malignant ascites fluid are usually produced. As a
consequence, severe swelling of the abdomen occurs. Not only is
this exceedingly painful for the patient, but unless the ascites
fluid is removed on a periodic basis (painful for the patient and
expensive to perform), the accumulation of ascites fluid can be
life-threatening. There is no treatment on the market that will
slow the production of malignant ascites fluid.
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