PharmaCyte Biotech Reports Positive Interim Results in Malignant Ascites Mouse Model Study
July 19 2022 - 8:30AM
Business Wire
PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company
focused on developing cellular therapies for cancer, diabetes, and
malignant ascites using its signature live-cell encapsulation
technology, Cell-in-a-Box®, announced today that it has achieved
positive interim results in its study to establish a malignant
ascites mouse model which will form the basis for further testing
of the effectiveness of its CypsCaps™ plus ifosfamide pancreatic
cancer therapy for the treatment of malignant ascites.
The study is being conducted by Heidelberg Pharma, a leading
German biotechnology company focused on cancer therapies, using
colon carcinoma cells from a Master Cell Bank established by
Austrianova implanted in genetically susceptible mice. Primary
objectives include establishing parameters with respect to (i)
optimum tumor cell inoculation dose; (ii) timing curve with respect
to tumor growth; and (iii) the most accurate method to assess tumor
burden. The last point is particularly important because it
provides a gauge to measure the effectiveness of therapeutic
interventions.
Initial data in the study indicate that a measure of overall
tumor volume is likely a more accurate way of tracking tumor burden
when compared to measuring labeled tumor cell fluorescence. Tumor
volume in the study is being reported using an adaptation of the
Sugarbaker-index. The Sugarbaker-index is a widely used and
accepted quantitative prognostic indicator for patients with
malignant ascites.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said,
“We are highly encouraged that Heidelberg Pharma’s work with this
study to establish a malignant ascites mouse model is proceeding
exactly as we had hoped and that it has yielded valuable
information as we work diligently to advance our therapy for
malignant ascites. We are confident that all our objectives in this
study will be achieved. We will continue to keep our shareholders
informed as work progresses at Heidelberg Pharma.”
Malignant ascites is caused by an accumulation of fluid in the
peritoneum causing the abdomen to swell as a result of cancer. It
is often associated with ovarian, uterine, cervical, colorectal,
stomach, pancreatic, breast and liver cancers. Malignant ascites
can result in significant impairment to the quality of life of a
cancer patient and reduce survival. Currently, available treatments
are mainly supportive and palliative. In most patients, development
of malignant ascites is a sign of advanced disease and poor
prognosis.
PharmaCyte expects its treatment to offer cancer patients a
therapy that slows down or eliminates the production and
accumulation of malignant ascites fluid. There is currently no such
treatment on the market.
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, diabetes and malignant ascites 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,
diabetes and malignant ascites 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 candidate 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.
PharmaCyte’s therapy for malignant ascites involves using the
same encapsulated cells PharmaCyte employs for pancreatic cancer
but placing the encapsulated cells in the peritoneal cavity of a
patient and administering ifosfamide intravenously.
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 PharmaCyte’s
management and Board of Directors. Any statements contained in this
press release which do not describe historical facts are
forward-looking statements 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
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
https://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/20220719005524/en/
Investor Relations: PharmaCyte Biotech, Inc. Telephone:
917.595.2856 Email: InvestorRelations@PharmaCyte.com Attn: Dr.
Gerald W. Crabtree
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