PharmaCyte Biotech Successfully Completes 36 Month Master Cell Bank Stability Study

Rhea-AI Summary

PharmaCyte Biotech (NASDAQ: PMCB) has completed a significant 36-month stability study of cells from its Master Cell Bank, crucial for its treatment of locally advanced pancreatic cancer (LAPC). This study, required by the FDA to lift a clinical hold on its CypCaps product, confirms that the cells are stable and viable when stored in liquid nitrogen. The ongoing research will continue to assess the maximum shelf life of these cells. PharmaCyte plans to include findings from this study in its Complete IND Submission to the FDA.

Positive

• Successful completion of a 36-month stability study of Master Cell Bank cells.
• Cells have confirmed shelf life and viability for use in treatment.
• Data from this study will be critical for lifting the FDA's clinical hold.

Negative

• None.

LAS VEGAS--(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^®, today announced that it has successfully completed a 36-month stability study of the cells from its Master Cell Bank (MCB). These cells will be encapsulated and then used to treat locally advanced, inoperable pancreatic cancer (LAPC). This stability study is one of the items that the U.S. Food and Drug Administration (FDA) requires PharmaCyte to complete for its clinical trial product, CypCaps™, in an effort to lift the FDA’s clinical hold. This means that the cells used to produce the CypCaps have a shelf life of at least 36 months when stored in a vapor phase of liquid nitrogen. Vapor phase temperature for liquid nitrogen is between -140°C and -180°C.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed 36-month stability study, “The ongoing study to determine the maximum shelf life of the MCB cells has reached another important milestone. Cells from our MCB successfully completed the required tests to prove that the cells are stable and remain active after being stored frozen for 36 months in a vapor phase of liquid nitrogen.

“Analysis of the cells from our MCB after 36 months showed that the cells passed all of the specified tests, including cell viability, identity testing, sterility, enzyme activity and cell potency as well as pH, label check and appearance of the cells.

“This study will continue in order to determine the maximum shelf life of the cells from our MCB. It is distinct from the other ongoing stability study on the shelf life of our CypCaps that continue to be stored at approximately -80°C. While the storage temperatures are different for the MCB cells and the CypCap cells, the tests for both stability studies are the same.”

This ongoing stability study was initiated prior to the submission of PharmaCyte’s Investigational New Drug Application (IND) to the FDA. The information and data obtained from this stability study and other studies will form part of PharmaCyte’s Complete IND Submission of information that PharmaCyte will provide to the FDA to have the clinical hold lifted.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211228005018/en/

Investor Relations:

Dr. Gerald W. Crabtree

PharmaCyte Biotech, Inc.

Telephone: 917.595.2856

Email: InvestorRelations@PharmaCyte.com

Source: PharmaCyte Biotech, Inc.

FAQ

What is the significance of the 36-month stability study for PharmaCyte Biotech (PMCB)?

The study is crucial for demonstrating the viability of cells used in CypCaps, necessary for lifting the FDA's clinical hold.

When was the 36-month stability study for PMCB completed?

The study was completed recently, as announced in the latest press release by PharmaCyte Biotech.

How does the stability study impact the clinical trial for CypCaps?

The positive results of the study support the safety and efficacy of using MCB cells in ongoing clinical trials for pancreatic cancer.

What are the storage conditions for the cells studied by PharmaCyte (PMCB)?

The cells were stored in a vapor phase of liquid nitrogen at temperatures between -140°C and -180°C.