PharmaCyte Biotech Announces Positive Results of Biocompatibility Study for FDA

Rhea-AI Summary

PharmaCyte Biotech (NASDAQ: PMCB) announced the initial results of biocompatibility studies for its CypCaps product, a component in its pancreatic cancer treatment. The study confirmed that the cellulose sulphate capsules do not activate the complement system, a key part of the human immune response, ensuring safety for patients. Conducted by a third-party GLP lab, this study is part of ongoing research to evaluate the CypCaps' effectiveness and compatibility. Further results from additional studies are expected in the coming weeks.

Positive

• Initial biocompatibility study results confirm that CypCaps do not activate the complement system, indicating potential safety for patients.
• The study was conducted by an independent, third-party GLP laboratory, enhancing credibility of the results.
• Anticipation of additional study results in the coming weeks could positively influence investor sentiment.

Negative

• None.

LAGUNA HILLS, Calif.--(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 first test results of the biocompatibility studies of its CypCaps^™ clinical trial product candidate. These results were from an “In Vitro Complement Activation Study of Empty Cellulose Sulphate Capsules,” the same capsules PharmaCyte uses in its treatment for pancreatic cancer.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “A number of studies are currently ongoing by independent, third-party CROs on the biocompatibility of our CypCaps pancreatic cancer product candidate and its components. We are pleased to report that we have received the results from the first of these studies showing that, as expected, the capsule material does not activate a major line of the human body’s innate defense - the complement system. This is just one of the biocompatibility studies that are being performed and, in the coming weeks, we expect that the results of other studies will become available.”

The complement system consists of multiple proteins, approximately 30 of which are circulating blood proteins that work together to promote immune and inflammatory responses. The complement system’s principal role is to help identify, destroy, and remove foreign pathogens such as bacteria and viruses, as well as damaged cell materials (for example, cells and proteins).

The objective of the ISO 10993-4: 2017 (E) compliant study was to evaluate the complement activation potential of empty cellulose sulphate capsules when mixed with normal human serum complement under in vitro test conditions. The study was performed by a third-party GLP laboratory. That laboratory concluded that empty cellulose sulphate capsules did not activate the complement system under defined experimental conditions based on the results of the study. These results were also supported by statistical comparisons.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210916005259/en/

Dr. Gerald W. Crabtree

Investor Relations:

PharmaCyte Biotech, Inc.

Investor Relations Department

Telephone: 917.595.2856

Email: InvestorRelations@PharmaCyte.com

Source: PharmaCyte Biotech, Inc.

FAQ

What are the latest results from PharmaCyte Biotech regarding its CypCaps product?

PharmaCyte Biotech reported that initial biocompatibility studies for CypCaps showed that the capsules do not activate the complement system, indicating safety.

What does the biocompatibility study for CypCaps involve?

The study evaluated the complement activation potential of cellulose sulphate capsules using normal human serum in controlled laboratory conditions.

When can we expect more results from PharmaCyte Biotech's CypCaps studies?

PharmaCyte expects to receive results from additional biocompatibility studies in the coming weeks.

How does PharmaCyte Biotech's CypCaps relate to pancreatic cancer treatment?

CypCaps are used in PharmaCyte's treatment for locally advanced inoperable pancreatic cancer, functioning to safely activate chemotherapy drugs at the tumor site.