PharmaCyte Biotech Strengthens Protection of Cancer Therapy with Patent Filing
March 22 2017 - 9:20AM
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®, today announced that it has filed a
provisional patent application with the United States Patent and
Trademark Office (USPTO) to protect its therapy to treat cancerous
tumors, including the therapy that will be used in its upcoming
clinical trial in locally advanced pancreas cancer (LAPC).
The patent application specifically includes
methods of treating all cancerous tumors, such as pancreas, liver,
breast and colon, using the live-cell encapsulation of genetically
modified human cells that overexpress a form of the Cytochrome P450
enzyme system normally found in the liver. These cells are
encapsulated using the Cell-in-a-Box® technology. Together with low
doses of ifosfamide, the encapsulated cells comprise PharmaCyte’s
therapy for cancerous tumors. The patent application also includes
using PharmaCyte’s platform technology with cyclophosphamide,
another chemotherapy drug that must be activated by the Cytochrome
P450 enzyme system.
“By filing for a new patent, we have begun
taking steps to obtain patent protection for 20 years to protect
our therapy for all forms of malignant tumors. This is particularly
important to the company as we are taking steps to embark upon a
clinical trial in pancreas cancer,” said PharmaCyte’s Chief
Executive Officer, Kenneth L. Waggoner. “We will be filing for new
patent protection in all of the countries in which PharmaCyte
currently has patent protection for pancreas cancer.”
Provisional patent applications are a way to
establish and protect a "date of invention" or "priority filing
date" for one year. The provisional patent application was created
to provide inventors with a way to begin protecting their
inventions. A provisional patent application provides PharmaCyte 12
months to prepare a full patent application during which it can
label its inventions as "patent pending." It also enables
PharmaCyte to establish an early effective filing date for a
patent.
The family of patents that deal with the subject
matter of the new patent application are set to expire on March 27,
2017. The new patent application is designed to continue patent
protection of PharmaCyte’s therapy for cancerous tumors. It is not
an extension of the existing patents. A new patent for PharmaCyte’s
cancer therapy, if granted by the USPTO, will provide another 20
years of patent protection from the date of the filing of this
Provisional Patent Application - March 21, 2017.
PharmaCyte therapy for pancreas cancer is
already protected. PharmaCyte’s pancreas cancer therapy was
designated an orphan drug and listed in the official registry of
medicinal products for rare diseases by the U.S. Food and Drug
Administration (FDA) on December 17, 2014. This orphan drug status
assures marketing exclusivity for PharmaCyte’s pancreas cancer
therapy in the U.S. for 7 years after market approval by the FDA.
Similarly, PharmaCyte has orphan drug status in the European Union
(EU) for its pancreas cancer therapy. This designation provides 10
years of marketing exclusivity in all countries in the EU following
approval by the European Medicines Agency (EMA).
In addition, the Biologics Price Competition and
Innovation Act (BPCIA), which was enacted as part of the Affordable
Care Act in 2010, establishes a period of 12 years of “data
exclusivity” for reference products to preserve incentives for
future innovation. Under this framework, data exclusivity protects
the data in the innovator’s regulatory application by prohibiting
others, for a period of 12 years, from gaining FDA approval based
in part on reliance on or reference to the innovator’s data in a
biosimilar application. PharmaCyte’s 12-year exclusivity will begin
as soon as the FDA approves the company’s pancreas cancer
therapy.
Mr. Waggoner concluded by stating, “While this
patent application should make our investors feel assured about the
protection of our pancreas cancer therapy, they should understand
that if our pancreas cancer therapy receives FDA approval, the
orphan drug designation in the U.S. and the EU, together with the
BPCIA data exclusivity, will give us substantial marketing
exclusivity for our pancreas cancer therapy. This new patent
application, while it does include our pancreas cancer therapy,
should really be viewed as an opportunity to dramatically broaden
PharmaCyte’s ability to protect our therapy for all malignant
tumors for the next 20 years.”
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage
biotechnology company developing therapies for cancer and diabetes
based upon a proprietary cellulose-based live cell encapsulation
technology known as “Cell-in-a-Box®.” This technology will be used
as a platform upon which therapies for several types of cancer and
diabetes are being developed. PharmaCyte’s therapy for cancer
involves encapsulating genetically engineered human cells that
convert an inactive chemotherapy drug into its active or
“cancer-killing” form. These encapsulated cells are implanted as
close to the patient’s cancerous tumor as possible. Once implanted,
a chemotherapy drug that is normally activated in the liver
(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 implanted. When the ifosfamide comes
in contact with the encapsulated cells they act as an artificial
liver and activate the chemotherapy drug at the source of the
cancer. This “targeted chemotherapy” has proven effective and safe
to use in past clinical trials and results in no side effects.
In addition to developing a novel therapy for
cancer, PharmaCyte is developing a treatment for Type 1 diabetes
and insulin-dependent Type 2 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. Once the encapsulated cells are
implanted in a diabetic patient they will function as a
“bio-artificial pancreas” for purposes of insulin production.
Safe Harbor
This press release contains forward-looking
statements, which are generally statements that are not historical
facts. Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking
statements are based on management's current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. We undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our control. Actual results or
outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
risk factors, many of which are discussed in more detail in our
Annual Report on Form 10-K and our other reports filed with the
Securities and Exchange Commission.
More information about PharmaCyte Biotech can be found at
www.PharmaCyte.com. It can also be obtained by contacting Investor
Relations.
Contact:
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com