PharmaCyte Biotech’s Live-Cell Encapsulation Facility is Commissioned for GMP Manufacture
April 25 2016 - 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®, today reported that the encapsulation
facility for its pancreatic cancer therapy is ready to manufacture
PharmaCyte’s biologic product under current Good Manufacturing
Practices (GMP) standards. The facility will be used to encapsulate
the live cells used for PharmaCyte’s pancreatic cancer therapy. The
assessment was issued by Chamow & Associates, the
biopharmaceutical consulting firm that specializes in the
inspection of facilities for GMP compliance.
Dr. Steven Chamow of Chamow & Associates
stated, “Use of the live-cell encapsulation technology is very
complex with many manufacturing steps and processes. GMP readiness
of a biologic manufacturing facility such as the Bangkok site is no
exception. In a relatively short period of time, with the
relentless and determined cooperation we received from Austrianova,
the facility is ready for GMP manufacture to produce the
encapsulated cells that are a major part of PharmaCyte’s pancreatic
cancer therapy.”
PharmaCyte Biotech’s Chief Executive Officer,
Kenneth L. Waggoner, commented, “We are delighted to announce this
exciting milestone in the development of our therapy for pancreatic
cancer. This is a major step in generating the overall Chemistry,
Manufacturing and Controls (CMC) information, which makes up a
large part of the pre-IND package we will be submitting to the U.S.
Food and Drug Administration (FDA). We would like to thank Chamow
& Associates and Austrianova for completing this process. With
the facility ready for cGMP manufacture, we are now in a position
to engage with the FDA to discuss our clinical investigational plan
and initiate our first clinical trial.”
Over the last few months, following an initial
on-site audit of the facility by Chamow & Associates, numerous
detailed documents were required to be prepared, reviewed and
approved by Chamow. These documents include the quality management
system manual and a variety of facility-related standard operating
procedures (SOPs). In addition, all facility-related equipment has
successfully completed the necessary Installation Qualifications
(IQ) and Operational Qualifications (OQ).
Dr. Brian Salmons, the Chief Executive Officer
of Austrianova, said, “We are exceedingly pleased that we were able
to have our unique state-of-the-art live-cell encapsulation
facility assessed as ready for GMP manufacture by Chamow &
Associates. Both of the teams from Austrianova and Chamow worked
together seamlessly and virtually nonstop to ensure that the
facility is ready for GMP manufacture of PharmaCyte’s biologic
product. We did so to enable PharmaCyte to reach the clinic with
its novel therapy for pancreatic cancer at the earliest
opportunity.”
The Austrianova facility will be used to
encapsulate the genetically engineered live human cells that,
together with low doses of the cancer prodrug ifosfamide, make up
PharmaCyte’s pancreatic cancer therapy. PharmaCyte’s cancer therapy
attacks the pancreas tumor with “targeted chemotherapy,” resulting
in significant tumor shrinkage, the ability to convert some tumors
from inoperable to operable, a reduction in the pain associated
with the disease and an improvement to a patient’s overall quality
of life.
PharmaCyte’s upcoming clinical trial in advanced
inoperable pancreatic cancer involves placing the genetically
modified live cells near the blood supply to the pancreas. The
cancer prodrug ifosfamide is then given at one-third the normal
dose. The prodrug is converted to its active form at the site of
the tumor. In an earlier Phase 1/2 clinical trial, this “targeted
chemotherapy” demonstrated far greater efficacy than the then
“gold-standard” of care with no meaningful side-effects from the
chemotherapy. Patients enrolled in PharmaCyte’s clinical trial will
have non-metastatic, locally advanced and inoperable pancreatic
cancer. They will be eligible for the trial if their tumors are
either stable or progressing after 4-6 cycles of treatment with
either of the two most commonly used chemotherapies for these
cancers - the two-drug combination of Abraxane® plus gemcitabine or
the four-drug combination known as FOLFIRINOX. PharmaCyte’s therapy
will be compared in such patients with the current “standard of
care,” which consists of the combination of the anticancer drug
capecitabine plus radiation.
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. The encapsulated live cells are placed as
close to a cancerous tumor as possible. Once implanted in a
patient, ifosfamide is given intravenously at one-third the normal
dose. The ifosfamide is carried by the circulatory system to where
the encapsulated live 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 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