PharmaCyte Biotech CEO in Europe to Secure Orphan Designation With the EMA
October 07 2015 - 09:25AM
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, announced today that Kenneth L. Waggoner, Chief
Executive Officer of PharmaCyte Biotech, is currently in Europe
ironing out the details that will secure the European Medicines
Agency (EMA) Orphan Designation for PharmaCyte Biotech’s pancreatic
cancer treatment.
PharmaCyte Biotech’s treatment for advanced
pancreatic cancer consists of a unique encapsulation technology
known as “Cell-in-a-Box®” in combination with an inactive
chemotherapy drug (ifosfamide). The technology encapsulates living
cells that have been genetically modified to convert ifosfamide
into its active or “cancer-killing” form. The encapsulated
cells are first implanted into a patient’s pancreas as close to the
tumor as possible. Then ifosfamide is given intravenously as
any other chemotherapy agent is, but at one-third the normal dose
to eliminate side-effects usually associated with
chemotherapy. When the blood carries the ifosfamide to the
site of the tumor, activation of the ifosfamide takes place when it
comes in contact with the encapsulated live cells - rather than in
the liver where it is normally activated.
Waggoner said of his efforts in Europe,
“Securing the Orphan Designation in Europe for our pancreatic
cancer treatment is vital to our company, as we head into our Phase
2b clinical trial to treat advanced pancreatic cancer. With
the Orphan Designation, PharmaCyte Biotech will be provided 10
years of marketing exclusivity throughout Europe for its pancreatic
cancer treatment.”
PharmaCyte Biotech will now rely on Clinical
Network Services, its Contract Research Organization (CRO) in
Australia and Europe, to finalize the documents that will give
PharmaCyte Biotech the Orphan Designation with the EMA. Once
the European Commission has approved the documents, PharmaCyte
Biotech will make an announcement.
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 and diabetes are being developed.
PharmaCyte Biotech’s treatment for cancer
involves encapsulating genetically modified live cells designed to
convert 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 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 ifosfamide 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 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