PharmaCyte Biotech Provides Link to Orphan Drug Designation for Its Pancreatic Cancer Treatment
November 24 2015 - 9:25AM
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, Cell-in-a-Box®, announced today that the European
Commission has updated its website to reflect that PharmaCyte
Biotech Europe Limited, a subsidiary of PharmaCyte Biotech, Inc.,
is the “sponsor” or holder of the Orphan Drug designation in Europe
for PharmaCyte’s pancreatic cancer treatment.
The European Commission’s website is now
available to verify that the Orphan Drug designation has been
obtained by PharmaCyte. View the European Commission’s updated page
here:
http://ec.europa.eu/health/documents/community-register/html/o149.htm
PharmaCyte has been assured that the European
Medicines Agency (EMA) is in the process of updating its records to
reflect that PharmaCyte has obtained the Orphan Drug designation.
Receiving the Orphan Drug designation in Europe for PharmaCyte’s
pancreatic cancer treatment carries with it 10 years of marketing
exclusivity in countries in the European Union. In addition, the
EMA provides special assistance in the development of PharmaCyte’s
treatment for pancreatic cancer.
The Orphan Drug designation in the European
Union is given to drugs for life-threatening diseases with low
prevalence, or that make it unlikely an investment in a drug would
be cost justified to treat the life threatening disease, and that
the drug has been shown to provide a significant benefit to
patients being treated by the drug.
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. 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 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 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.
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 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