PharmaCyte Biotech Announces Additional Quality Control Testing and Confirms CypCap Cell Stability
PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cell therapies for cancer, diabetes and malignant ascites using its live cell encapsulation technology, Cell-in -a-Box®, today announced the results of a study to determine whether a previous established quantitative real-time PCR (qRT-PCR) could be used as a quality control test for its CypCaps™ product candidate. The qRT-PCR was used to obtain data from syringe testing of clinical batches of PharmaCyte’s cGMP production for its planned clinical trial in locally advanced and inoperable pancreatic cancer.
PharmaCyte President and CEO Kenneth L. Waggoner commented on this new confirmatory test saying, “With the completion of this study, the company has completed another important item on the long list of tasks required by Food and Drug Administration (FDA) of the United States. for our pancreatic cancer product candidate. We are particularly pleased that this independently performed qRT-PCR once again demonstrates the stability at the genetic level of cytochrome P450-expressing cells that drive our clinical trial product CypCaps. Additionally, we continue to make steady progress and remain committed in our efforts to resubmit an Investigational New Drug Application to the FDA and have our clinical hold lifted.
The study, performed by a third-party laboratory, confirmed that qRT-PCR can be successfully implemented for testing, and it also confirmed the identity and stability of the cytochrome P450 expression construct in the cells used for the production of CypCaps before and after encapsulation in the cGMP batches. qRT-PCR will therefore be used as a quality control (QC) release test on future clinical batches of cGMP-grade CypCaps. The results obtained from the recently reported study also serve as further evidence that the integrated cytochrome P450 construct is highly stable in the clinical cell line used for CypCaps.
PharmaCyte is at the end of its process of responding to FDA requests to allow the clinical hold to be lifted, having now successfully completed nearly two dozen studies with only a few remaining to be completed. The company plans to begin its two-phase swine study soon, which is the FDA’s latest major study.
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced and inoperable pancreatic cancer, we encourage you to watch the company’s documentary video with medical animations at : https://www.PharmaCyte.com/Cancer
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. is a biotechnology company developing cell therapies for cancer, diabetes and malignant ascites based on a proprietary cellulose-based live cell encapsulation technology known as “Cell-in- a-Box”.®.” This technology is used as a platform on which therapies are developed for several types of cancer, diabetes and malignant ascites.
PharmaCyte’s cancer therapy encapsulates genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer” form. For pancreatic cancer, these encapsulated cells are implanted into the blood supply to the patient’s tumor as close to the tumor site as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. Ifosfamide is transported through the circulatory system to where the encapsulated cells have been implanted. When ifosfamide passes through the pores of the capsules, the living cells inside act like a “bio-artificial liver” and activate the chemotherapy drug at the cancer site. This “targeted chemotherapy” has been shown to be effective and safe in previous clinical trials and we believe it has few or no treatment-related side effects.
PharmaCyte’s candidate 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 blood sugar levels in the human body. Cell line encapsulation 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 the purpose of insulin production.
PharmaCyte’s therapy for malignant ascites uses the same encapsulated cells that PharmaCyte uses for pancreatic cancer, but places the encapsulated cells in a patient’s peritoneal cavity and administers ifosfamide intravenously.
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 PharmaCyte’s management and board of directors. All statements in this press release that do not describe historical facts are forward-looking statements 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 satisfactorily resolve issues raised by the FDA to remove the clinical hold from our IND, and other factors included in periodic reports on Form 10-K and Form 10-Q that we file with the United States 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 any forward-looking statements, except as required by law, whether as a result of new information, future events or otherwise.
More information about PharmaCyte Biotech can be found at https://www.PharmaCyte.com.
Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.