PharmaCyte Biotech Discusses Major Milestones Ahead of Phase 2b Clinical Trial in Pancreatic Cancer
September 15 2015 - 9:30AM
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®, discussed today some of the major
“milestone” tasks that must be completed to begin its Phase 2b
clinical trial in pancreatic cancer. The trial will test the
effectiveness and safety of PharmaCyte Biotech’s pancreatic cancer
treatment. This treatment consists of the combination of
microcapsules with genetically modified live cells in combination
with low doses of the chemotherapy drug ifosfamide. These
encapsulated live cells are placed as close to a cancerous tumor as
possible to enable the delivery of the highest levels of the
cancer-killing drug at the source of the patient’s cancer.
In the coming weeks and months, a number of
major “milestone” tasks will take place that will enable PharmaCyte
Biotech’s first clinical trial to commence. Many of these must be
completed before a formal Investigational New Drug application
(“IND”) is filed with the drug regulatory authorities.
- Finalization of Trial Design: With pivotal input from
PharmaCyte Biotech’s renowned team of oncologists, the design of
its clinical trial will be finalized with the goal of creating the
highest probability of developing positive data during the trial
that could lead to marketing approval of its treatment for
pancreatic cancer.
- IND Team: An IND Team will be established to prepare the IND
and review it before being formally submitted to the regulatory
authorities. PharmaCyte Biotech’s IND Team, many of whom have
already been retained, will include: (i) a Project Manager; (ii) a
Medical Officer; (iii) a Statistician; (iv) a Chemistry,
Manufacturing and Controls Expert; (v) a Pharmacologist; (vi) a
Pharmakineticist; (vii) a Toxicologist; (viii) an Interventional
Radiologist; (ix) a Radiologist; and (x) a Regulatory Affairs
person.
- Chemistry, Manufacturing and Controls Information: The
manufacturing of investigational biological products are subject to
stringent regulatory considerations. PharmaCyte Biotech will be
working with Austrianova – the manufacturer of the encapsulated
live cells used in PharmaCyte Biotech’s treatment for pancreatic
cancer – to develop this information.
- Clinical Protocol: A “protocol” will be prepared with by its
Contract Research Organization with the invaluable assistance of
PharmaCyte Biotech’s team of oncologists. The clinical protocol can
be viewed as a “recipe” on how the clinical trial will be
conducted. The protocol will include such things as: (i) the
qualifications needed for particular patients to be included in the
trial; (ii) how PharmaCyte Biotech’s treatment and the treatment
used in the “comparator” arm of the study will be administered and
the schedule and duration of these treatments; (iii) the specific
“endpoints” for the trial and the types of data that will be
collected to determine these endpoints; and (iv) the types of data
analysis that will be employed in reaching conclusions about the
overall success of the trial.
- Pre-IND Meeting: This meeting will be requested by PharmaCyte
Biotech and initiates communication with the drug regulatory
authorities that will be responsible for approving its product to
market. This communication is particularly important for a company
like PharmaCyte biotech that is developing a new product or
technology. The purpose of a pre-IND meeting is to discuss the
information that will be used to prepare the IND, such as product
characterization, final and in-process testing of the product,
previous animal test data, prior clinical trial data and the
proposed clinical protocol. Input from the regulatory authorities
given during the pre-IND meeting will lead to “fine-tuning” the
clinical trial protocol and will identify any additional items that
may need to be included in the IND.
- Clinical Trial Study Sites: Clinical study sites will be
evaluated and enrolled to participate in the clinical trial. Each
site will need to be multidisciplinary in nature, where medical
oncologists, interventional radiologists, radiologists and other
cancer specialists work together to offer multidisciplinary cancer
treatments and who will work in concert in conducting their part of
the clinical trial.
- IND: An Investigational New Drug application will be submitted
to the drug regulatory authorities before PharmaCyte Biotech can
begin the clinical trial. The IND will include animal study data,
toxicity (side effects that cause great harm) data, manufacturing
information, the clinical protocol for the trial, data from any
prior human clinical trials and information about the Principal
Investigator who will oversee all aspects of the trial.
PharmaCyte Biotech’s Chief Executive Officer,
Kenneth L. Waggoner, commented on the process underway at the
company, “A well thought out clinical trial design and program is
critical for the long-term effectiveness of efforts to bring our
treatment for pancreatic cancer through the regulatory approval
process. Bringing a new cancer therapy through the approval process
requires an in depth understanding of the complex drug development
process and the integral role that each member of our team plays in
that process. Proper planning and addressing the critical steps in
the development of that process are essential. Because of our
outstanding team of oncologists and our other team members, we
believe that we are taking measures to avoid unnecessary expenses
and barriers in navigating our treatment to a successful
conclusion.”
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, including advanced pancreatic cancer and its symptoms, and
diabetes are being developed.
PharmaCyte Biotech’s treatment for cancer
involves encapsulating genetically modified live cells capable of
converting the prodrug ifosfamide into its active or
“cancer-killing” form. These encapsulated live cells are placed as
close to a cancerous tumor as possible to enable the delivery of
the highest levels of the cancer-killing drug at the source of the
cancer. Ifosfamide is then given intravenously at one third the
normal dose. When the ifosfamide comes in contact with the
encapsulated live cells through the circulatory system, the
activation of the drug takes place at or near the tumor without any
side effects. This “targeted chemotherapy” has proven remarkably
effective and safe to use in past clinical trials.
In addition to developing treatments for
cancers, 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 on demand 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