PharmaCyte Biotech Launches Malignant Ascites Program with Commencement of Pivotal Preclinical Study

Rhea-AI Summary

PharmaCyte Biotech (NASDAQ: PMCB) has announced a pivotal study targeting malignant ascites associated with locally advanced, inoperable pancreatic cancer. This study will evaluate the efficacy of the Cell-in-a-Box technology combined with ifosfamide to delay malignant ascites production. The research, overseen by Dr. Matthias Löhr, aims to replicate promising results from previous studies. Currently, no approved therapies exist for delaying malignant ascites, highlighting the potential impact of PharmaCyte's innovative approach.

Positive

• Commencement of a pivotal study focusing on malignant ascites treatment.
• Potential to change treatment landscape as no current therapies exist for malignant ascites.
• Collaborative preclinical study with Heidelberg Pharma suggests a proactive research approach.

Negative

• Dependent on the successful completion and results of upcoming studies, which involve regulatory scrutiny.
• Challenges remain in addressing FDA issues related to clinical holds.

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 the commencement of a pivotal study to determine if the treatment PharmaCyte uses for locally advanced, inoperable pancreatic cancer—Cell-in-a-Box (CypCaps^™) combined with the cancer killing prodrug ifosfamide—can also delay the rate of production and accumulation of malignant ascites. This is fluid that accumulates in the abdominal cavity from various cancers.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We are enthusiastic to relaunch our malignant ascites program and resume our work on developing a treatment for malignant ascites. We plan to conduct another preclinical study in Germany with Heidelberg Pharma that mimics an earlier study which showed the production of malignant ascites can be delayed by our cancer treatment. The cancer cells we will be using in the study have been ordered, and the design of the protocol is underway.

“The Chairman of our Medical and Scientific Advisory Board, Dr. Matthias Löhr, is overseeing the study. We will be using the same animal study model that Dr. Löhr used in the earlier study that showed promise.”

Malignant ascites is fluid secreted by abdominal tumors which includes liver, breast, colon, stomach, intestine, ovarian and uterine cancers. This fluid contains cancer cells that can seed and form new tumors throughout the abdomen. Malignant ascites accumulates in the abdominal cavity, causing swelling of the abdomen, severe breathing difficulties and extreme pain. It must be removed on a periodic basis, which is painful and costly.

Currently, there is no available therapy that prevents or delays the production and accumulation of malignant ascites. PharmaCyte plans to change the treatment landscape for malignant ascites fluid using its treatment.

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/20211129005760/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 PharmaCyte Biotech's new study about?

PharmaCyte's new study aims to evaluate the effectiveness of its Cell-in-a-Box technology combined with ifosfamide in delaying the production of malignant ascites in pancreatic cancer patients.

What is malignant ascites?

Malignant ascites is the accumulation of fluid in the abdominal cavity caused by certain types of cancer, leading to severe symptoms and requiring painful periodic removal.

What is the significance of the Cell-in-a-Box technology?

Cell-in-a-Box technology encapsulates genetically engineered cells to convert inactive chemotherapy drugs into active forms directly at the tumor site, aiming for targeted and effective cancer treatment.

What are the next steps for PharmaCyte after this announcement?

PharmaCyte plans to conduct a preclinical study in Germany and is currently designing the study protocol and sourcing cancer cells for the research.

How could this study impact the stock price of PMCB?

Success in the pivotal study could enhance investor confidence and potentially increase PMCB's stock price as it addresses an unmet medical need in cancer treatment.