PharmaCyte Biotech Obtains Orphan Drug Designation in Europe for Its Pancreatic Cancer Treatment
November 17 2015 - 9:22AM
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, upon the
recommendation of the European Medicines Agency (EMA), the European
Commission has granted the Orphan Drug designation to PharmaCyte’s
subsidiary, PharmaCyte Biotech Europe Limited, for PharmaCyte’s
pancreatic cancer treatment. Receiving Orphan Drug designation 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 to
treat a life-threatening disease would be cost justified, and that
demonstrate there is a significant benefit to patients being
treated with the drug.
PharmaCyte’s Chief Executive Officer, Kenneth L.
Waggoner, commented on the significance of PharmaCyte obtaining the
Orphan Drug designation, saying, “Obtaining Orphan Drug designation
from the European Commission represents another significant
milestone in the development of PharmaCyte’s pancreatic cancer
treatment. This achievement is an exceedingly important one when
coupled with the FDA’s granting of the same designation last year.
It further facilitates the development of PharmaCyte’s pancreatic
cancer treatment and once again serves to validate the
Cell-in-a-Box® technology as a treatment for one of the most
dreaded forms of cancer.”
PharmaCyte’s pancreatic cancer treatment
consists of encapsulating genetically modified live cells capable
of converting the anticancer prodrug ifosfamide into its
cancer-killing form and placing the capsules as close to the
cancerous tumor in the pancreas as possible. Then low doses of the
inactive chemotherapy drug ifosfamide are given to the patient.
When ifosfamide, which is carried by blood to where the capsules
have been placed, comes in contact with the live cells, the drug is
converted into its cancer killing form at the site of the disease
rather than in the liver where conversion normally takes place.
This technology enables high concentrations of the chemotherapeutic
drug to be delivered directly to the cancer, without any
treatment-related side effects like those normally associated with
cancer chemotherapy.
PharmaCyte is preparing for a clinical trial
designed to determine whether its pancreatic cancer treatment
(Cell-in-a-Box® capsules + low-doses of ifosfamide) can satisfy a
critical unmet medical need for patients with advanced pancreatic
cancer when the gold standard of care, the combination of
gemcitabine and Abraxane®, are no longer effective. The trial will
be conducted in the United States with additional study sites in
Europe and Australia.
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 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 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