PharmaCyte Biotech Releases More Positive Results From FDA-Required Biocompatibility Tests
September 21 2021 - 9:00AM
Business Wire
PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company
focused on developing cellular therapies for cancer and diabetes
using its signature live-cell encapsulation technology,
Cell-in-a-Box®, announced today the results of a second U.S. Food
and Drug Administration (FDA)-required test of biocompatibility of
its CypCaps™ product for pancreatic cancer, which showed that the
empty capsule material is “non-hemolytic.”
The Chief Executive Officer of PharmaCyte Biotech, Kenneth L.
Waggoner, said of the positive results, “We’re pleased to report
that we have received positive results from the second of the
biocompatibility tests performed under Good Laboratory Practices
and required by the FDA in connection with PharmaCyte’s clinical
hold. The data shows that, as expected, the capsule material does
not cause blood cells to lyse either after direct or indirect
contact with blood. Moreover, it confirms prior data that was
observed previously in animal models and previous clinical
trials.”
The study, which was performed by a third-party Contract
Research Organization in accordance with ISO 10993-4:2017 and ISO
10993-12:2021(E), was designed to determine if the device component
of CypCaps (the empty capsule material) can cause the in vitro
hemolysis (destruction) of red blood cells. Two different methods
were used for the evaluation: (i) a direct contact method where the
capsule material was mixed with rabbit blood; and (ii) an indirect
method where the capsule material was extracted with saline and
mixed with rabbit blood. The hemolytic index of both the empty
capsules and the extraction material was such that the Contract
Research Organization concluded that the test item in both the
direct contact method and indirect contact method is considered as
“non-hemolytic.”
To learn more about PharmaCyte’s pancreatic cancer treatment and
how it works inside the body to treat locally advanced inoperable
pancreatic cancer, we encourage you to watch the company’s
documentary video complete with medical animations at:
https://www.PharmaCyte.com/Cancer
About PharmaCyte Biotech PharmaCyte Biotech, Inc. is a
biotechnology company developing cellular therapies for cancer and
diabetes based upon a proprietary cellulose-based live cell
encapsulation technology known as “Cell-in-a-Box®.” This technology
is being 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. For
pancreatic cancer, these encapsulated cells are implanted in the
blood supply to the patient’s tumor as close as possible to the
site of the tumor. 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 flows through pores in the capsules,
the live cells inside act as a “bio-artificial liver” and activate
the chemotherapy drug at the site of the cancer. This “targeted
chemotherapy” has proven effective and safe to use in past clinical
trials and we believe results in little to no treatment related
side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent
Type 2 diabetes involves encapsulating 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 of the cell line will be done using the Cell-in-a-Box
technology. Once the encapsulated cells are implanted in a diabetic
patient, we anticipate that they will function as a “bio-artificial
pancreas” for purposes of insulin production.
Safe Harbor
This press release may contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that express the current beliefs and expectations of the management
of PharmaCyte. Any statements contained herein that do not describe
historical facts are forward-looking statements that are subject to
risks and uncertainties that could cause actual results,
performance and achievements to differ materially from those
discussed in such forward-looking statements. Factors that could
affect our actual results include our ability to raise the
necessary capital to fund our operations and to find partners to
supplement our capabilities and resources, our ability to
satisfactorily address the issues raised by the FDA in order to
have the clinical hold on our IND removed, as well as such other
factors that are included in the periodic reports on Form 10-K and
Form 10-Q that we file with the U.S. Securities and Exchange
Commission. These forward-looking statements are made only as of
the date hereof, and we undertake no obligation to update or revise
the forward-looking statements, except as otherwise required by
law, whether as a result of new information, future events or
otherwise.
More information about PharmaCyte Biotech can be found at
www.PharmaCyte.com. Information may also be obtained by contacting
PharmaCyte’s Investor Relations Department.
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version on businesswire.com: https://www.businesswire.com/news/home/20210921005440/en/
Dr. Gerald W. Crabtree Investor Relations:
PharmaCyte Biotech, Inc. Investor Relations Department Telephone:
917.595.2856 Email: InvestorRelations@PharmaCyte.com
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