SILVER SPRING, MD, August 25, 2015 (GLOBE NEWSWIRE) – PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, provided an update on the progress of completing the compliance process for Austrianova’s cGMP (current Good Manufacturing Practices-compliant) facility in the Thai Science Park in Bangkok, Thailand. This is the facility that will encapsulate genetically modified human cells in the Cell-in-a-Box® capsules PharmaCyte Biotech will use in its clinical trials in cancer and diabetes.
Austrianova is in the process of completing installation qualification, operational qualification and performance qualification on the clean room and associated areas, as well as all of the machines required for the manufacturing process at its cGMP facility. As part of these activities, Austrianova has just successfully completed an audit by an expert who has been active in the pharmaceutical industry for more than 15 years and who has held a position at a leading European inspector for cGMP inspections. Currently, the auditor is an external expert for the World Health Organization (WHO), assisting in inspections for the WHO prequalification program that ensures the safe and secure supply of medical products for critical therapies. The expert was retained to perform an audit of the facility in Bangkok and Austrianova’s state of the art, web-based electronic quality system.
Prof. Walter H. Günzburg, Chief Technical Officer at Austrianova, said, “We are very pleased to announce that the inspector did not find any major issues that would prevent the cGMP production of Cell-in-a-Box®. The next step in the process is to carry out the necessary engineering or “shake-down” runs at the facility, which will involve running through the production process and generating data on the qualified equipment. These tests are required before the facility can start work on the production of the three “consecutive runs” that will be used to demonstrate compliance of the production process with cGMP standards.”
Commenting on the progress of Austrianova, PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, said, “As with any biotechnology company developing new medical products, our goal is to comply fully with all of the regulatory requirements. In establishing this new production process, we and Austrianova are starting from ‘ground zero.’ It is remarkable that the very laborious, rigorous and intensive procedures that are necessary for cGMP-compliant production are progressing so rapidly. We are exceedingly pleased with the progress being made by Austrianova.”
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®.” This unique and patented technology will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer and its related symptoms, as well as diabetes are being developed.
PharmaCyte Biotech’s treatment for pancreatic cancer involves encapsulating genetically modified human cells that convert the prodrug ifosfamide into its active or “cancer-killing” form. These encapsulated live cells are placed as close to the tumor as possible to enable the delivery of the highest levels of the cancer-killing drug at the source of the cancer. Ifosfamide is then given intravenously at one-third the normal dose to eliminate the side effects normally associated with chemotherapy. When the ifosfamide comes in contact with the encapsulated live cells through the circulatory system, the activation of ifosfamide takes place at or near the tumor. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.
PharmaCyte Biotech is also developing treatments for cancer based upon the encapsulation of chemical constituents of the Cannabis plant. It is examining ways to exploit the benefits of the Cell-in-a-Box® technology in optimizing the anticancer effectiveness of Cannabis, while at the same time minimizing or outright eliminating the debilitating side effects often associated with cancer treatments.
In addition to developing treatments for pancreatic and other cancers, PharmaCyte Biotech is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte Biotech plans to encapsulate a human cell line which has been genetically engineered to produce, store and secrete insulin on demand at levels in proportion to the levels of blood sugar in the human body. The encapsulation of the insulin producing live cells will be done using the Cell-in-a-Box® technology.
Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan” and similar expressions, as they relate to PharmaCyte Biotech or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte Biotech, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte’s ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte Biotech’s intellectual property and PharmaCyte Biotech’s continued ability to raise capital. PharmaCyte Biotech does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: [email protected]
