PharmaCyte Biotech Announces More Positive Tests Results for Its Pancreatic Cancer Clinical Trial Product Candidate to Satisfy FDA Requirements

Rhea-AI Summary

PharmaCyte Biotech, Inc. (NASDAQ: PMCB) announced that its pancreatic cancer trial product candidate, CypCaps™, has shown no systemic toxicity in recent studies. Conducted by a third-party organization, the study involved assessing empty cellulose sulphate capsules' toxicity in mice, aligning with FDA standards. Results confirmed that none of the test subjects exhibited clinical signs of toxicity, weight changes, or mortality. CEO Kenneth L. Waggoner emphasized the study's importance in validating the capsule's inert nature, supporting ongoing development of their targeted chemotherapy solution for pancreatic cancer.

Positive

• No systemic toxicity observed in the CypCaps™ study.
• The study validates previous data on capsule material's inertness.
• Successfully conducted by a third-party Contract Research Organization.

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 comprises its pancreatic cancer clinical trial product candidate does not cause systemic toxicity.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “Another important study has been conducted and concluded. This time the study evaluated the potential toxicity of the capsule component of our CypCaps™ clinical trial product candidate. We are pleased to announce that there was no evidence of toxicity in this animal study in any of the parameters examined and that the study confirms previous data that the capsule material is inert.”

The study, which was performed by a third-party Contract Research Organization, involved the ISO compliant testing of an extract of empty cellulose sulphate capsules provided by Austrianova for potential acute systemic toxicity in mice, according to ISO 10993-11: 2017(E), an FDA recognized consensus standard. Upon intraperitoneal injection of capsule extract, the mice were observed for clinical signs of toxicity at 30 to 40 min, 1 hour, 2 hours and 4 hours post dosing on day 1. On days 2, 3, 7 and 14, all of the animals were observed once daily for clinical signs and twice daily for mortality.

The body weight of the mice was recorded prior to administration of the capsule extract on day 1 and on days 2, 3, 4, 7 and 14 during the observation period. At the end of observation period, all the animals were examined for signs of toxicity. The analyses revealed that none of the mice died or showed any clinical signs of toxicity or gross pathological changes as compared to control mice. Moreover, no treatment related changes were noted in body weight and percent change in body weight with respect to day 1 values and all animals revealed a normal increase in body weight during the observation period.

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/20220419005425/en/

Dr. Gerald W. Crabtree

PharmaCyte Biotech, Inc.

Investor Relations Department

Telephone: 917.595.2856

Email: Info@PharmaCyte.com

Source: PharmaCyte Biotech, Inc.

FAQ

What were the results of PharmaCyte's recent toxicity study for CypCaps™?

PharmaCyte's toxicity study showed no systemic toxicity in mice, confirming the inert nature of CypCaps™.

What is the significance of the study conducted by PharmaCyte?

The study validates the safety of the encapsulation technology used in PharmaCyte's pancreatic cancer treatment.

When did PharmaCyte announce the results of the toxicity study?

PharmaCyte announced the results of the toxicity study on [insert appropriate date].

What is the next step for PharmaCyte after the toxicity study?

PharmaCyte aims to continue developing its pancreatic cancer treatment based on the positive study results.