PharmaCyte Biotech’s Live-Cell Encapsulation Facility is Commissioned for GMP Manufacture
SILVER SPRING, Md., April 25, 2016 (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®, today reported that the encapsulation facility for its pancreatic cancer therapy is ready to manufacture PharmaCyte’s biologic product under current Good Manufacturing Practices (GMP) standards. The facility will be used to encapsulate the live cells used for PharmaCyte’s pancreatic cancer therapy. The assessment was issued by Chamow & Associates, the biopharmaceutical consulting firm that specializes in the inspection of facilities for GMP compliance.
Dr. Steven Chamow of Chamow & Associates stated, “Use of the live-cell encapsulation technology is very complex with many manufacturing steps and processes. GMP readiness of a biologic manufacturing facility such as the Bangkok site is no exception. In a relatively short period of time, with the relentless and determined cooperation we received from Austrianova, the facility is ready for GMP manufacture to produce the encapsulated cells that are a major part of PharmaCyte’s pancreatic cancer therapy.”
PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, commented, “We are delighted to announce this exciting milestone in the development of our therapy for pancreatic cancer. This is a major step in generating the overall Chemistry, Manufacturing and Controls (CMC) information, which makes up a large part of the pre-IND package we will be submitting to the U.S. Food and Drug Administration (FDA). We would like to thank Chamow & Associates and Austrianova for completing this process. With the facility ready for cGMP manufacture, we are now in a position to engage with the FDA to discuss our clinical investigational plan and initiate our first clinical trial.”
Over the last few months, following an initial on-site audit of the facility by Chamow & Associates, numerous detailed documents were required to be prepared, reviewed and approved by Chamow. These documents include the quality management system manual and a variety of facility-related standard operating procedures (SOPs). In addition, all facility-related equipment has successfully completed the necessary Installation Qualifications (IQ) and Operational Qualifications (OQ).
Dr. Brian Salmons, the Chief Executive Officer of Austrianova, said, “We are exceedingly pleased that we were able to have our unique state-of-the-art live-cell encapsulation facility assessed as ready for GMP manufacture by Chamow & Associates. Both of the teams from Austrianova and Chamow worked together seamlessly and virtually nonstop to ensure that the facility is ready for GMP manufacture of PharmaCyte’s biologic product. We did so to enable PharmaCyte to reach the clinic with its novel therapy for pancreatic cancer at the earliest opportunity.”
The Austrianova facility will be used to encapsulate the genetically engineered live human cells that, together with low doses of the cancer prodrug ifosfamide, make up PharmaCyte’s pancreatic cancer therapy. PharmaCyte’s cancer therapy attacks the pancreas tumor with “targeted chemotherapy,” resulting in significant tumor shrinkage, the ability to convert some tumors from inoperable to operable, a reduction in the pain associated with the disease and an improvement to a patient’s overall quality of life.
PharmaCyte’s upcoming clinical trial in advanced inoperable pancreatic cancer involves placing the genetically modified live cells near the blood supply to the pancreas. The cancer prodrug ifosfamide is then given at one-third the normal dose. The prodrug is converted to its active form at the site of the tumor. In an earlier Phase 1/2 clinical trial, this “targeted chemotherapy” demonstrated far greater efficacy than the then “gold-standard” of care with no meaningful side-effects from the chemotherapy. Patients enrolled in PharmaCyte’s clinical trial will have non-metastatic, locally advanced and inoperable pancreatic cancer. They will be eligible for the trial if their tumors are either stable or progressing after 4-6 cycles of treatment with either of the two most commonly used chemotherapies for these cancers - the two-drug combination of Abraxane® plus gemcitabine or the four-drug combination known as FOLFIRINOX. PharmaCyte’s therapy will be compared in such patients with the current “standard of care,” which consists of the combination of the anticancer drug capecitabine plus radiation.
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