PharmaCyte Biotech Inc (PMCB)

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Progress in the Cancer Program

PharmaCyte Biotech's treatment (Cell-in-a-Box® plus low-doses of ifosfamide) for advanced, inoperable pancreatic cancer was granted the Orphan Drug designation by the U.S. Food and Drug Administration (FDA) in late December of 2014.
On the basis of very positive results from our first preclinical study (4 groups of tumor bearing mice) that was conducted by Translational Drug Development (TD2) in the U.S. to determine the ability of the Cell-in-a-Box® plus low-doses of ifosfamide combination to delay the accumulation of malignant ascites fluid produced by abdominal cancers, an expanded study (12 groups of mice) is currently being conducted by TD2. This study is designed to elucidate parameters that will be needed for a future clinical trial that may result in the only treatment that can slow down the accumulation of malignant ascites fluid. It is expected that the study will be completed in the next 2 months. The target date for the initiation of the Phase 1 clinical trial in the U.S. is the third quarter of 2015.
Preparations for the Phase 2b clinical trial in patients with advanced, inoperable pancreatic cancer are ongoing. Major documents, including the Investigators Brochure and a clinical protocol (a recipe for conducting the clinical trial) are in preparation, with the assistance of Clinical Network Services (CNS) - one of Australia's leading Clinical Research Organizations. The target date for the initiation of the Phase 2b clinical trial in Australia is the third quarter of 2015.
We initially reported that we expected to begin our Phase 2b clinical trial in the first quarter of 2015; however, we are awaiting the Good Manufacturing Practices (GMP) regulatory approval process that our partner, Austrianova, is currently involved with in order to get the GMP-compliant facility at the Thai Science Park in Bangkok, Thailand, approved to produce Cell-in-a-Box® capsules for human clinical trials. Austrianova believes the process will now be completed in the third quarter of 2015.
Progress is ongoing at the University of Northern Colorado in an attempt to identify a cell line that can be encapsulated using the Cell-in-a-Box® technology, which, in turn, can be used together with cannabinoid or cannabinoid-like prodrugs as a treatment for deadly cancers - such as brain and pancreatic cancer.