PharmaCyte Biotech to Engage Principal Investigator for Clinical Trial in Pancreatic Cancer
May 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®, today announced that PharmaCyte has
commenced its search for a Principal Investigator for its Phase 2b
clinical trial in advanced pancreatic cancer. PharmaCyte will be
meeting with potential candidates at this year’s annual meeting of
the American Society of Clinical Oncology (ASCO) being held in
Chicago, Illinois, June 3-7, 2016.
PharmaCyte’s Chief Operating Officer, Dr Gerald
W. Crabtree, commented, “It is crucial that the person selected for
this important position be a recognized expert in the treatment of
pancreatic cancer and someone who has had experience in multi-site
clinical trials for this devastating disease. It is also an
advantage if the person selected is familiar with the oncologists
who will lead the efforts at the specific study sites. Therefore,
it is imperative that PharmaCyte appoint the best available
pancreatic cancer authority possible to the post of Principal
Investigator to oversee the entire clinical trial.”
PharmaCyte plans to commence a Phase 2b clinical
trial in the United States, with study sites in Europe, to meet a
critical unmet medical need for patients who no longer benefit from
the combination chemotherapies of Abraxane® + gemcitabine or
FOLFIRINOX after 4-6 months of treatment and whose tumors are
inoperable and non-metastatic. Currently, chemotherapy + radiation
is used for such patients, but this treatment is only marginally
effective and carries with it significant side effects. The goal of
the trial is to show that PharmaCyte’s pancreatic cancer therapy
can serve as a consolidation therapy that is better than the
currently used therapy by exhibiting increased antitumor
effectiveness and reduced side effects.
The Principal Investigator is a recognized
expert in the area of oncology addressed in the clinical trial.
This person serves as the general supervisor for the entire trial
and acts as a mentor for the site investigators, protecting the
rights, safety and welfare of the patients. The Principal
Investigator also ensures that the trial is conducted at all study
sites in compliance with the clinical trial protocol, procedures
and regulations. In addition, the Principal Investigator plays a
major role in developing the final study report of the results of
the trial.
There is also an individual “site investigator”
at each study site. That is usually the oncologist on site
responsible for how the trial is conducted at that site. If a trial
is conducted by a team of oncologists at a trial site, the site
investigator is the responsible leader of the team that administers
the treatments described in the clinical trial protocol and
conducts treatment-related tests, protecting the rights, safety and
welfare of the patients under the site investigator’s care. When
tasks are delegated by a site investigator, the investigator is
responsible for providing adequate supervision of those to whom
tasks are delegated.
About PharmaCyte
BiotechPharmaCyte Biotech is a clinical stage
biotechnology company 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 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