PharmaCyte Biotech Clinical Trial Designed to Expand Standard of Care Therapy for Pancreatic Cancer
October 21 2015 - 9:20AM
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 the new trial design
for its upcoming clinical trial in patients with advanced
pancreatic cancer using PharmaCyte’s treatment (Cell-in-a-Box® +
low-dose ifosfamide chemotherapy).
The overall goal of the trial is to determine
whether PharmaCyte’s pancreatic cancer treatment can satisfy a
critical unmet medical need by acting as a consolidation therapy
for patients who no longer respond to the combination of
nab-paclitaxel (Abraxane®) + gemcitabine – currently the “gold
standard” for the treatment of pancreatic cancer. Treatments for
this group of patients are only marginally effective. The trial
will compare the effectiveness of PharmaCyte’s pancreatic cancer
treatment “head-to-head” using several criteria with one of the
commonly used treatments for these patients - the combination of
the cancer drug capecitabine (Xeloda®) + x-radiation. Capecitabine,
which can be given orally, is a “prodrug” form of the widely used
chemotherapeutic agent 5-fluorouracil (5-FU) that is given
intravenously.
The trial will be conducted in the United
States, with study sites in Europe and Australia. Eligible patients
will be randomly placed into two groups. The patients in Group 1
will receive PharmaCyte’s pancreatic cancer treatment. The patients
in Group 2 will receive treatment with the combination of
capecitabine + x-radiation. Two of the most important factors in
the trial design are: (i) the eligibility criteria for accepting
patients into the trial; and (ii) the factors to be considered to
determine whether PharmaCyte’s treatment has been successful in
achieving its goals (endpoints).
- Eligibility Criteria: The patients accepted into the trial must
have pancreatic cancer that is inoperable, but that has not yet
spread from the pancreas where it first started to another place in
the body (metastatic cancer). These patients must also have tumors
that no longer respond to the combination chemotherapy treatment of
Abraxane® + gemcitabine and that have been on the treatment for a
period of between four and six months.
- Endpoints of the Trial: The primary endpoints will be: (i)
progression-free survival; and (ii) the side effects from the
treatment that occur in the patients. Progression-free survival
(PFS) is the time that elapses from the first day of treatment
until the disease gets worse. PFS will be determined at 6 and 12
months. The occurrence of any side effects will be monitored
throughout the trial.The trial design also includes several
secondary endpoints. Among the most important are: (i) the onset of
pain and the patient’s need for pain medications; (ii) whether the
inoperable tumors become operable as a result of the treatment;
(iii) the change in tumor size; and (iv) the patient’s overall
quality of life during the treatment.
The design of the trial was a collaborative
effort between PharmaCyte, Translational Drug Development (TD2),
America’s premier Contract Research Organization (CRO) specializing
in oncology, world renowned oncologists Dr. Mathias Löhr of the
famed Karolinska Institute in Stockholm and the Chairman of
PharmaCyte’s Scientific Advisory Board, and Dr. Manuel Hidalgo,
Director of Clinical Research at the Spanish National Cancer
Research Center and a member of PharmaCyte’s Scientific Advisory
Board.
PharmaCyte’s Chief Executive Officer, Kenneth L.
Waggoner, said of the newly designed trial, “The design of our
upcoming clinical trial was truly a collaborative effort among
world renowned experts in oncology and science. In the trial
design, personnel at TD2, Dr. Löhr, Dr. Hidalgo and Dr.Korn at
Imaging Endpoints have shown why they have been on the forefront of
developing new oncology drugs for advanced pancreatic cancer in
innovative ways that can best treat patients with this dreadful
disease. By working together as a team, they have accelerated the
timeline for getting our pancreatic cancer treatment into the
marketplace and have addressed a critical unmet medical need. We
could not be more pleased with the trial new design.”
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 that 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 HarborThis 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