PharmaCyte Biotech to Accelerate Preparations for Start of Pancreatic Cancer Clinical Trial

Rhea-AI Summary

PharmaCyte Biotech, Inc. (NASDAQ: PMCB) is accelerating preparations for its Phase 2b clinical trial focused on locally advanced, inoperable pancreatic cancer (LAPC) using CypCaps™. CEO Kenneth L. Waggoner highlighted the company's favorable study results and solid financial position, allowing for immediate preparations to enroll the first patient. Key tasks include finalizing trial protocols, reengaging contractors, and manufacturing syringes for the trial. This innovative therapy utilizes encapsulated cells to activate chemotherapy drugs at tumor sites, promising targeted treatment with minimal side effects.

Positive

• Accelerated preparations for Phase 2b clinical trial in LAPC.
• Favorable results from studies satisfying FDA requirements.
• Strong financial position to support clinical advancements.

Negative

• Dependence on lifting FDA clinical hold to commence trial.

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 PharmaCyte has decided to accelerate preparations for the start of its Phase 2b clinical trial in locally advanced, inoperable pancreatic (LAPC) using its CypCaps^TM clinical trial product.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of accelerating enrollment of the first patient, “The plan is to begin the work now to prepare for the enrollment of the first patient so that we can begin the trial almost immediately upon getting the clinical hold lifted.

“Because we continue to receive favorable results from each of the studies that we have conducted to satisfy the FDA’s requirements and because of the company’s financial position, we are ideally situated to begin the work necessary to enroll the first patient now to run parallel with the work being done to get the clinical hold lifted. Previously, our plan was to begin the work to commence a clinical trial in LAPC after the FDA lifted the clinical hold.”

The work to enroll the first patient includes finalizing the (i) clinical trial protocol; (ii) pharmacy manual; (iii) investigator’s brochure; (iv) angiography manual; (v) informed consent; and (vi) drug product label.

PharmaCyte will also need to reengage with Medpace, the Contract Research Organization that PharmaCyte has selected to conduct its proposed clinical trial. PharmaCyte will also need to reengage its subcontractors who will assist Medpace. Catalent Pharma Solutions, PharmaCyte’s supply chain vendor, must also be reengaged and the supply chain requirements must be updated.

Clinical trial syringes containing CypCaps™ will need to be manufactured and delivered to Catalent’s locations throughout the U.S. for storage and distribution for the clinical trial. Those syringes have already been ordered from Austrianova and are in the process of being manufactured.

The final list of cancer centers will need to be selected and contracts must be negotiated and finalized with each center.

Also, the lead interventional radiologist must be selected, a training film must be developed, and the lead interventional radiologist will need to train additional interventional radiologists.

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 PharmaCyte’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/20220413005367/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 focus of PharmaCyte's Phase 2b clinical trial?

PharmaCyte's Phase 2b clinical trial focuses on locally advanced, inoperable pancreatic cancer (LAPC).

What technology is PharmaCyte using in its cancer treatment?

PharmaCyte is using its proprietary live-cell encapsulation technology, Cell-in-a-Box®, to develop cancer therapies.

What are the next steps for PharmaCyte after the press release?

PharmaCyte plans to finalize clinical trial protocols, reengage contractors, and prepare for patient enrollment as soon as the FDA lifts the clinical hold.

When will the Phase 2b trial for LAPC begin?

The Phase 2b trial for LAPC is set to begin almost immediately after the FDA lifts the clinical hold.

What are CypCaps™ in PharmaCyte's clinical trial?

CypCaps™ are the clinical trial product used in PharmaCyte's therapy for activating chemotherapy drugs at the tumor site for pancreatic cancer treatment.