PMCB - PharmaCyte completes stability study as part of process to get clinical hold lifted

PharmaCyte Biotech (PMCB +1.9%) said it successfully completed a 36-month stability study of the cells from its Master Cell Bank (MCB), as part of its efforts to get a clinical hold lifted by the U.S. Food and Drug Administration (FDA). This stability study is one of the items that the FDA requires PharmaCyte to complete for its clinical trial product, CypCaps in an effort to lift the clinical hold which was placed last year in October. These cells will be encapsulated and then used to treat locally advanced, inoperable pancreatic cancer. The company said that the cells used to produce the CypCaps have a shelf life of at least 36 months when stored in a vapor phase of liquid nitrogen. PharmaCyte’s CEO, Kenneth Waggoner said “Analysis of the cells from our MCB after 36 months showed that the cells passed all of the specified tests, including cell viability, identity testing, sterility, enzyme

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PharmaCyte completes stability study as part of process to get clinical hold lifted