PharmaCyte Biotech Announces More Positive Tests Results for Its Pancreatic Cancer Clinical Trial Product Candidate to Satisfy FDA Requirements
April 19 2022 - 09:00AM
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 that the empty capsule material
that comprises its pancreatic cancer clinical trial product
candidate does not cause systemic toxicity.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said,
“Another important study has been conducted and concluded. This
time the study evaluated the potential toxicity of the capsule
component of our CypCaps™ clinical trial product candidate. We are
pleased to announce that there was no evidence of toxicity in this
animal study in any of the parameters examined and that the study
confirms previous data that the capsule material is inert.”
The study, which was performed by a third-party Contract
Research Organization, involved the ISO compliant testing of an
extract of empty cellulose sulphate capsules provided by
Austrianova for potential acute systemic toxicity in mice,
according to ISO 10993-11: 2017(E), an FDA recognized consensus
standard. Upon intraperitoneal injection of capsule extract, the
mice were observed for clinical signs of toxicity at 30 to 40 min,
1 hour, 2 hours and 4 hours post dosing on day 1. On days 2, 3, 7
and 14, all of the animals were observed once daily for clinical
signs and twice daily for mortality.
The body weight of the mice was recorded prior to administration
of the capsule extract on day 1 and on days 2, 3, 4, 7 and 14
during the observation period. At the end of observation period,
all the animals were examined for signs of toxicity. The analyses
revealed that none of the mice died or showed any clinical signs of
toxicity or gross pathological changes as compared to control mice.
Moreover, no treatment related changes were noted in body weight
and percent change in body weight with respect to day 1 values and
all animals revealed a normal increase in body weight during the
observation period.
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 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/20220419005425/en/
Dr. Gerald W. Crabtree PharmaCyte Biotech, Inc. Investor
Relations Department Telephone: 917.595.2856 Email: Info@PharmaCyte.com
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