On July 23, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed a study on the stability after "hand thawing" syringes of the Cell-in-a-Box encapsulated cells that will be used, in combination with low doses of the cancer prodrug ifosfamide, for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, JUL 23, 2018, View Source [SID1234528930]). The data obtained from this "hand thawing" study is required by the U.S. Food and Drug Administration (FDA).
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The filing of an Investigational New Drug Application (IND) requires that the clinical product, as well as the product’s use, should be well characterised. PharmaCyte’s Cell-in-a-Box is a cutting edge Advanced Therapy Medicinal Product (ATMP). Therefore, numerous studies are needed since such a product has never been tested before in the United States. The laboratory scale "thawing" study previously conducted (View Source) determined how long the once-frozen Cell-in-a-Box encapsulated cells are still fit for use after thawing, as would occur in a clinical setting before the Cell-in-a-Box capsules are implanted into a patient with LAPC. That study defined one of the important parameters for the upcoming planned clinical trial for LAPC.
At individual study sites, the frozen cells in the Cell-in-a-Box capsules within syringes will be hand-thawed and then kept at room temperature until they are implanted into a patient with LAPC. The results of the "hand thawing" study announced today show that the viability of the cells remains essentially the same for at least 30 minutes at room temperature. This serves to define the time that the interventional radiologist has to implant the Cell-in-a-Box capsules after thawing to ensure cellular viability within the patient.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, explained the significance of the study saying, "This is yet another important study that PharmaCyte has completed to comply with the FDA’s requirements for our planned, upcoming clinical trial in LAPC. The Cell-in-a-Box encapsulated cells are in a frozen state before they are administered to the patient. This study was designed to determine how long after unfreezing the Cell-in-a-Box encapsulated cells can they be held at room temperature before being introduced into the patient without losing their effectiveness.
"This is important since the treatment depends on the viability of our genetically engineered live human cells in order to produce the cytochrome P450 enzyme for the activation of the chemotherapy prodrug ifosfamide. The study’s goal was to determine how long the cells remained viable at room temperature after thawing; thus, mimicking how long the clinicians and interventional radiologists will have to administer the capsules to the patient in the hospital. The newly completed studies show how long that Cell-in-a-Box encapsulated cells can be kept at room temperature for optimal activity."