PharmaCyte Biotech Releases More Positive Results From FDA-Required Biocompatibility Tests

Rhea-AI Summary

PharmaCyte Biotech (NASDAQ: PMCB) announced positive results from its second FDA-required biocompatibility test of the CypCaps™ product, revealing that the capsule material is non-hemolytic. This test confirms earlier findings that the biocompatibility of the capsule does not cause blood cell destruction. Conducted by a third-party organization, the results align with PharmaCyte’s goal of developing cellular therapies for pancreatic cancer and diabetes using its Cell-in-a-Box® technology, enhancing prospects for clinical advancement.

Positive

• Successful results from the second FDA-required biocompatibility test for CypCaps™.
• Confirmation that capsule material is non-hemolytic, aligning with previous data.
• Promotes the advancement of cellular therapies for pancreatic cancer and diabetes.

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 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.

View source 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

Source: PharmaCyte Biotech, Inc.

FAQ

What are the results of PharmaCyte Biotech's recent FDA test for CypCaps™?

PharmaCyte Biotech reported successful results from the second FDA-required biocompatibility test, confirming that the CypCaps™ capsule material is non-hemolytic.

How does PharmaCyte's CypCaps™ technology work for pancreatic cancer?

CypCaps™ encapsulates genetically engineered human cells that activate chemotherapy drugs specifically at the tumor site, minimizing side effects.

What is the significance of the non-hemolytic result for PharmaCyte Biotech?

The non-hemolytic result suggests that the capsule material is safe for use, which is crucial for future clinical trials.

What technology does PharmaCyte Biotech use for its therapies?

PharmaCyte Biotech utilizes a proprietary Cell-in-a-Box® technology for its cellular therapies targeting cancer and diabetes.