PharmaCyte Biotech Announces Stability Test Results on Cells from Master Cell Bank

Rhea-AI Summary

PharmaCyte Biotech (OTCQB: PMCB) announced that its cytochrome P450 expressing cells from the Master Cell Bank, stored for three years in liquid nitrogen, retain viability and excellent enzymatic activity. This is crucial for the effectiveness of its CypCaps cancer therapy, which activates ifosfamide to combat tumors. The stability of these cells, requested by the FDA, is vital for future clinical trials. CEO Kenneth L. Waggoner expressed satisfaction with the results, emphasizing ongoing studies to ensure maximum stability for future CypCaps production.

Positive

• Retention of cell viability and enzymatic activity after 3 years of storage.
• Positive implications for the effectiveness of CypCaps therapy.
• Ongoing studies to ensure maximum stability of Master Cell Bank cells.

Negative

• None.

PharmaCyte Biotech, Inc. (OTCQB: 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 after 3 years of storage in a vapor phase of liquid nitrogen, the original cytochrome P450 expressing cells from PharmaCyte’s Master Cell Bank (MCB) manufactured by Eurofins Lancaster Laboratories continue to retain their viability and excellent enzymatic activity, both of which are critical stability parameters.

This study is in addition to, and distinct from, the previously positive stability study test results of the CypCaps product after storage at -80C over various timepoints.

The enzymatic activity is the property that causes the activation of low dose ifosfamide in patients and subsequently the killing of their cancerous tumors. Thus, having good enzymatic activity is a direct measure of the effectiveness of the cells. It is important to show stability of the MCB cells since these cells will be used as a resource for continued production of future batches of PharmaCyte’s clinical trial product referred to as CypCaps™. For this reason, the U.S. Food and Drug Administration requested that the stability of the MCB cells be analyzed.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We are pleased to have generated data on the viability and enzymatic activity of cells from our Master Cell Bank after 3 year’s storage. The study will proceed over the next three years to obtain the maximum stability of the cells from the MCB after continuous storage in liquid nitrogen, ensuring that we have a resource for future production of our CypCaps as this novel therapy makes its way into the clinic.”

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, the chemotherapy prodrug ifosfamide that is normally activated in the liver 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 prodrug ifosfamide 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 liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is also considering the use of genetically modified stem cells to treat diabetes. The encapsulation of the cell lines 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 in this press release 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 up-list our common stock to a national securities exchange and then maintain such listing, raise the necessary capital to fund our operations and to find partners to supplement our capabilities and resources, satisfactorily address the issues raised by the by the U.S. Food and Drug Administration in order to have the clinical hold removed on our Investigational New Drug Applications so that we may proceed with our planned clinical trial for locally advanced and inoperable pancreatic cancer, as well as such other factors that are included in our 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/20210712005269/en/

FAQ

What did PharmaCyte Biotech announce regarding its Master Cell Bank?

PharmaCyte announced that the cytochrome P450 expressing cells from its Master Cell Bank retain viability and enzymatic activity after three years in liquid nitrogen.

How does the stability of the Master Cell Bank cells affect CypCaps therapy?

The stability ensures that the cells can effectively activate ifosfamide, enhancing the treatment's ability to kill cancerous tumors.

What is the significance of the FDA's involvement in the study of Master Cell Bank cells?

The FDA requested the stability analysis of the Master Cell Bank cells to ensure they meet necessary standards for future clinical trials.

What are the future plans for PharmaCyte's cell studies?

PharmaCyte plans to continue studies over the next three years to maximize the stability of the cells from the Master Cell Bank.

What are CypCaps and how are they related to PharmaCyte's technology?

CypCaps are a cancer therapy product utilizing PharmaCyte's live-cell encapsulation technology, intended to activate the chemotherapy prodrug ifosfamide at the tumor site.