PharmaCyte Biotech Announces Cell Encapsulation Technology Material Does Not Cause Skin Irritation

Rhea-AI Summary

PharmaCyte Biotech (NASDAQ: PMCB) announced that the capsule material of its CypCaps pancreatic cancer product does not cause skin irritation, supporting its Investigational New Drug (IND) application to the FDA. CEO Kenneth L. Waggoner noted that this data reaffirms the safety of CypCaps, moving them closer to a clinical trial for locally advanced, inoperable pancreatic cancer. A third-party study showed no toxicity or skin reactions in New Zealand white rabbits after intracutaneous injection of the capsule extract. PharmaCyte focuses on cellular therapies for cancer and diabetes using its Cell-in-a-Box technology.

Positive

• The capsule material of CypCaps is confirmed safe and non-irritating.
• Data supports PharmaCyte's progress towards FDA clinical trial approval.
• Successful third-party study reinforces the product's safety profile.

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^®, announced today that the empty capsule material that makes up its CypCaps^™ pancreatic cancer product does not cause skin irritation.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We continue to demonstrate that our pancreatic cancer product is safe and performs just as we presented it in the Investigational New Drug application (IND) we submitted to the U.S. Food and Drug Administration (FDA). This latest positive data on the CypCaps product is one more example that brings us closer to updating our full package of information to address the FDA’s comments on our initial IND submission.

“This latest study demonstrates conclusively that the capsule material is not an irritant to the skin and confirms previously submitted data that the capsule material of our CypCaps product is inert. This result strengthens one of our responses to the FDA concerning our IND requesting a clinical trial for locally advanced, inoperable pancreatic cancer.”

The skin irritation study, which was performed by a third-party Contract Research Organization, involved the ISO compliant testing of an extract of empty cellulose sulphate capsules for intracutaneous reactivity in New Zealand white rabbits. The study was performed in compliance with the OECD Principles of Good Laboratory Practice [C(97)186/Final and ENV/MC/CHEM (98)17] and in accordance with ISO 10993 Part 10:2010(E). The extracts were injected intracutaneously at five different sites on the anterior part of the trunk of the rabbits, and the animals were observed for 3 days. After injection, there were no clinical signs of toxicity or mortality in any of the animals. Furthermore, no treatment-related changes were seen in the body weights of the rabbits after administration of the empty capsule extract. Importantly, none of the animals revealed treatment-related skin reactions during the 72-hour observation period. Thus, it was concluded that the extracts of empty cellulose sulphate capsules are not a skin irritant in the New Zealand white rabbits.

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/20211112005296/en/

Investor Relations:

Dr. Gerald W. Crabtree

PharmaCyte Biotech, Inc.

Telephone: 917.595.2856

Email: InvestorRelations@PharmaCyte.com

Source: PharmaCyte Biotech, Inc.

FAQ

What recent announcement did PharmaCyte Biotech make regarding its pancreatic cancer product CypCaps?

PharmaCyte Biotech announced that the capsule material of CypCaps does not cause skin irritation, supporting its FDA IND application.

How does the safety data for CypCaps impact PharmaCyte's FDA application?

The positive safety data strengthens PharmaCyte's responses to the FDA and brings them closer to clinical trial approval for CypCaps.

What was the outcome of the skin irritation study conducted by PharmaCyte?

The study confirmed that the empty cellulose sulphate capsules used in CypCaps are not a skin irritant, showing no toxicity in tested rabbits.

What technology does PharmaCyte Biotech utilize in its cellular therapies?

PharmaCyte Biotech uses its proprietary Cell-in-a-Box technology for developing therapies for cancer and diabetes.