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®, released today the third article in a
series of Q&A articles that will be conducted with some of the
key team members of PharmaCyte’s upcoming clinical trial in locally
advanced, inoperable pancreatic cancer (LAPC).
This interview-style Q&A article is with Dr.
Stephen Gately, the President and Chief Executive Officer of
Translational Drug Development (TD2), a world-class drug
development service specializing in getting the newest and best
oncology treatments to cancer patients as quickly as possible, and
PharmaCyte’s CRO for its upcoming clinical trial in LAPC.
As the CRO for PharmaCyte's upcoming clinical
trial in pancreatic cancer, can you explain what the role of TD2
has been before the trial begins and what that role will be once
the trial begins?
Dr. Stephen Gately: “As the CRO
for PharmaCyte, TD2 has been instrumental in the development of the
study design and developing the plans to operationalize the study.
TD2 will assign a project manager, and this individual is going to
be the single point of contact for the project. Study sites and
investigators will be recruited and qualified using feasibility
questionnaires and on-site visits during the time prior to the
start of the trial.
“TD2 will continue to work with PharmaCyte’s
imaging group to develop the procedure manual for implanting the
CypCaps. This will require written procedures and instructions as
well as developing a training and qualifying program for the site
interventional radiologist. The goal is to have this completed
prior to study start so that patient enrollment won’t be
delayed.
“TD2 will continue to build the clinical
database where the clinical date will be entered and stored. The
goal is to have the database ready to go live prior to study
start.
“There are a number of plans that are written to
detail the activities for data management, medical monitoring,
safety management, laboratory manual, pharmacy manual, site
monitoring and the statistical analysis plan.”
Once PharmaCyte has the go-ahead to begin its
clinical trial, what is the patient enrollment process?
Dr. Stephen Gately: “Once given
the go-ahead (IND has cleared the FDA), the project manager will
begin focusing on getting the sites up and running. Contracts and
budgets need to be put in place with each site. The protocol will
need to be reviewed and approved by each site’s Institutional
Review Board. A series of documents, called essential documents,
need to be collected from the sites and need to be on file at TD2.
Once this has been completed then a site activation visit will take
place for each site. The purpose of this visit is to educate and
train the site how to conduct the study appropriately. The training
and qualification of the interventional radiologist must be
completed by this time as well. Once this has been completed, the
site will be activated and CypCaps will be shipped to the
site.
“Once the site has received the CypCaps then the
screening process can begin. The principal investigator or
sub-investigator will identify a patient, and the patient will be
screened in accordance with the procedures listed in the protocol.
The patient must meet the inclusion and exclusion criteria under
the protocol to be eligible for the study. The patient’s records
will be reviewed by the medical monitor, and the patient will be
declared eligible. The site will schedule the patient for the
procedure. The site personnel will enter the patient into the
clinical database and begin data collection.”
How does TD2 find patients?
Dr. Stephen Gately: “TD2 will
work with qualified sites that have an interest in treating
patients with pancreas cancer. These sites have been successful in
accruing patients to pancreas cancer clinical trials. The site will
screen their patients as described above.”
We understand that there are databases of
potential patients that TD2 has access to fill PharmaCyte’s trial
and others. How do these patients end up in the databases?
Dr. Stephen Gately: “With the
Federal Electronic Medical Records (EMR)) mandate, all health care
facilities are required to convert all medical records to
electronic medical records (EMR). An electronic health record
(EHR), or electronic medical record (EMR), refers to the
systematized collection of patient and population electronically
stored health information in a digital format. These records can be
shared across different health care settings. Records are shared
through network-connected, enterprise-wide information systems or
other information networks and exchanges. EHRs may include a range
of data, including demographics, medical history, medication and
allergies, immunization status, laboratory test results, radiology
images, vital signs, personal statistics like age and weight and
billing information.
“There are a number of technologies that have
been developed that can search these records using the eligibility
criteria from the study to identify patients.”
Approximately how many clinical trial sites in
the U.S. does TD2 anticipate will be part of PharmaCyte’s
trial? Can you identify some of the candidates?
Dr. Stephen Gately: “TD2 is
planning on opening 12-15 sites for this study. This number may
change during the course of the study. The sites will be located
throughout the United States. These sites have been selected
because they have been successful in accruing patients to pancreas
cancer studies and have the expertise required to do the procedure
to implant the CypCaps. For instance, Dr. Manuel Hidalgo as the
principal investigator of the clinical trial will be enrolling
patients at the Beth Israel Deaconess Medical Center in Boston.
Candidates for the trial include Hoag Hospital Newport Beach,
Cedars-Sinai Medical Center in Los Angeles, Baylor University
Medical Center Dallas and HonorHealth Scottsdale Shea Medical
Center.”
During the clinical trial how closely will TD2
work with the Principal Investigator, Dr. Manuel Hidalgo?
Dr. Stephen Gately:
“Communication is the key to success of any project. The TD2
project manager will have biweekly calls scheduled with Dr.
Hidalgo, PharmaCyte and site investigators to discuss the progress
of the trial. These discussions will include, but will not be
limited to, patient care, safety issues, data collection,
enrollment rates and any other concerns that come up.”
TD2 has been involved in many clinical trials.
What are your early impressions of PharmaCyte's pancreatic cancer
therapy?
Dr. Stephen Gately: “New and
effective therapies for patients with pancreas cancer are clearly
needed. We have reviewed PharmaCyte’s prior human clinical data and
are encouraged that this approach may provide clinical benefit for
patients with pancreas cancer. TD2 is grateful for the opportunity
to work with PharmaCyte’s team on this exciting project.”
About PharmaCyte
BiotechPharmaCyte Biotech is a clinical stage
biotechnology company developing therapies 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 therapies for several types of cancer and
diabetes are being developed. PharmaCyte’s therapy for cancer
involves encapsulating genetically engineered human cells that
convert an inactive chemotherapy drug into its active or
“cancer-killing” form. These encapsulated cells are implanted as
close to the patient’s cancerous tumor as possible. Once implanted,
a chemotherapy drug that is normally activated in the liver
(ifosfamide) is given intravenously at one-third the normal dose.
The ifosfamide is carried by the circulatory system to where the
encapsulated cells have been implanted. When the ifosfamide comes
in contact with the encapsulated cells they act as an artificial
liver and activate the chemotherapy drug at the source of the
cancer. This “targeted chemotherapy” has proven effective and safe
to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for
cancer, PharmaCyte is developing a treatment for Type 1 diabetes
and insulin-dependent Type 2 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. Once the encapsulated cells are
implanted in a diabetic patient they will function as a
“bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release contains forward-looking
statements, which are generally statements that are not historical
facts. Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking
statements are based on management's current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. We undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our control. Actual results or
outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
risk factors, many of which are discussed in more detail in our
Annual Report on Form 10-K and our other reports filed with the
Securities and Exchange Commission.
More information about PharmaCyte Biotech can be
found at www.PharmaCyte.com. It can also be obtained by contacting
Investor Relations.
Contact:
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com