PharmaCyte Biotech Hires Industry-Leading Firm to Assist With Investigational New Drug Application
September 25 2015 - 9:25AM
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage
biotechnology company focused on developing targeted treatments for
cancer and diabetes announced today that it has contracted with
Chamow & Associates, located in the San Francisco Bay Area, to
assist with the Chemistry, Manufacturing and Control (CMC)
regulatory requirements for its Phase 2b clinical trial in advanced
pancreatic cancer. CMC information is a crucial part of the
Investigational New Drug (IND) application that PharmaCyte Biotech
will be submitting to the regulatory authorities. PharmaCyte
Biotech will leverage the expertise of Chamow & Associates in
this process.
The IND application is the seminal document that
must be acceptable to drug regulatory authorities and is the final
step before PharmaCyte Biotech’s Phase 2b clinical trial can
commence. The trial will assess the effectiveness of PharmaCyte
Biotech’s pancreatic cancer treatment (the combination of
microcapsules, produced using the Cell-in-a-Box® technology, and
low doses of the anticancer drug ifosfamide) against current
therapies for the unmet medical need for the disease.
Chamow & Associates, which was referred to
PharmaCyte Biotech by oncology research organization TD2 in
Scottsdale, Arizona, provides a variety of important services for
biotechnology companies. These services are related to CMC
requirements that PharmaCyte Biotech must take into account in
preparing its first IND application.
"We are excited to work with PharmaCyte Biotech
to support their work to develop a drug for advanced pancreatic
cancer," said Dr. Steven Chamow, principal at Chamow &
Associates. "We look forward to using our expertise in drug
development, quality and compliance to help them bring their
novel encapsulated live cell product to market.”
The initial services provided by Chamow &
Associates will involve sending experts to audit the Austrianova
encapsulation facility in Bangkok, Thailand, to ensure that it
complies with current Good Manufacturing Practices (cGMP). This
encapsulation facility will produce the Cell-in-a-Box® capsules
that will be used in PharmaCyte Biotech’s upcoming clinical trial
in the treatment of pancreatic cancer.
PharmaCyte Biotech’s Chief Executive Officer,
Kenneth L. Waggoner, commented, “We are very pleased to have
retained Chamow & Associates to perform critically important
CMC-related tasks for us. We are grateful to TD2 for recommending
Chamow & Associates. We believe we now have one of the most
capable consultants in the CMC arena that will enable us to
accurately develop information pertaining to the composition,
stability and controls used for the manufacturing of the
encapsulated live cells we will use in our treatment for advanced
pancreatic cancer.”
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, 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 an inactive chemotherapy drug (ifosfamide) 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, 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 ifosfamide,
which is normally activated in the liver, comes in contact with the
encapsulated live cells, activation of the 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 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 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.
About Chamow & Associates, Inc.
Chamow & Associates, Inc. is a biopharmaceutical services
group, based in the San Francisco Bay Area, offering strategic
guidance and operational management of CMC activities. Drawing on
the expertise of seasoned professionals with broad experience in
pharmaceutical development, the group’s services range from early
development of therapeutics (pre-IND or IND enabling) through NDA
or BLA in support of all aspects of CMC. These include process
development, manufacturing, quality, regulatory affairs and project
management.
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