PharmaCyte Biotech Reports on Audit of Live-Cell Encapsulation Facility by Chamow & Associates
March 03 2016 - 9:25AM
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage
biotechnology company focused on developing targeted therapies for
cancer and diabetes using its live-cell encapsulation technology,
Cell-in-a-Box®, reported today on Chamow & Associates’ (Chamow)
audit of Austrianova’s live-cell encapsulation facility in Bangkok,
Thailand, and the progress being made to establish that the
facility will be cGMP compliant. Chamow is a
biopharmaceutical consulting firm with industry experts that
specialize in the inspection of facilities for current Good
Manufacturing Practices (cGMP) compliance and in the preparation of
the Chemistry, Manufacturing and Controls (CMC) section of an
Investigational New Drug application (IND). The Austrianova
facility will employ the Cell-in-a-Box® technology to produce the
microcapsules that, together with low doses of the anticancer
prodrug ifosfamide, make up PharmaCyte’s therapy for pancreatic
cancer.
In December 2015, Chamow representatives visited
Austrianova’s encapsulation facility in the Thai Science Park in
Bangkok, Thailand, to perform a full cGMP audit of the facility.
Chamow subsequently presented a detailed audit report of its
findings to Austrianova and PharmaCyte. The audit report
included a complete examination of the components of the facility
and identified remaining cGMP goals to be finalized before the
required CMC section of the IND can be completed.
In commenting on the auditing process and his
impressions of the cell encapsulation facility, Dr. Steven Chamow,
President of Chamow & Associates, stated, “The Austrianova
production facility is a very well-designed facility with state of
the art equipment. Chamow & Associates will work with
Austrianova and PharmaCyte to ensure and verify that, when
complete, the facility and quality system modifications are
compliant with cGMP and therefore ready for the manufacture of
clinical trial material.” Dr. Chamow has nearly 30 years of
experience in biopharmaceutical product development, including
contributions to Genentech’s Avastin®, Johnson & Johnson’s
Natrecor® and Amgen’s Vectibix®.
Chamow’s audit is proving to be a solid
foundation on which the process is based to make certain that the
encapsulation facility is cGMP-compliant. Following
completion of the audit, Chamow continues to guide Austrianova in
responding to audit observations and to consult with PharmaCyte
throughout the process, including biweekly, in-depth
teleconferences which include personnel from Chamow, Austrianova,
Translational Drug Development (TD2) and PharmaCyte.
PharmaCyte’s Chief Executive Officer, Kenneth L.
Waggoner, commented, “When we received the audit report prepared by
Chamow & Associates we were pleased to read that the
Austrianova production facility is a well-designed, unique
facility, with state-of-the-art equipment, and that Austrianova has
initiated a robust quality assurance program and secured personnel
to competently execute cGMP manufacturing. We believe that,
through the use of the biweekly teleconferences between Chamow,
Austrianova, TD2 and ourselves, the full documentation necessary to
deem the facility cGMP-compliant and ready for the production of
clinical trial material can be completed in a timely manner that
will not adversely affect the initiation of our clinical
trial.”
In the United States, an IND must be submitted
to, and cleared by, the FDA before a clinical trial can begin.
One major section of an IND is the CMC section and, in turn,
the bulk of the CMC section itself, documents manufacture and
control of the investigational agent (drug or biologic product) in
accordance with cGMP standards and IND regulations. Whether a
manufacturing facility meets cGMP standards is not only dependent
upon the status and quality of the equipment within the facility,
but also depends upon exacting and in-depth documentation of such
items as the actual operation of the facility, the qualification
and certification of those working within the facility, standards
for production of the designated drug product and controls to
confirm quality. To ensure that Austrianova’s encapsulation
facility meets those standards, PharmaCyte retained Chamow who is
acting as a resource to PharmaCyte and Austrianova.
About PharmaCyte BiotechPharmaCyte Biotech is a
clinical stage biotechnology company focused on developing and
preparing to commercialize therapies 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 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.
About Chamow & Associates
Chamow & Associates is a consulting group
made up of industry experts based in the San Francisco Bay Area
providing product development and manufacturing services to
companies developing biopharmaceuticals. Its services include
advice, expertise and management of bulk process development, drug
manufacturing, formulation and delivery, quality, regulatory and
project management. To learn more, visit
www.chamowassociates.com.
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 Department
Telephone: 917.595.2856
Email: info@PharmaCyte.com