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PharmaCyte Biotech Inc (OTCMKTS:PMCB) Completes Pore Size Studies & 29 Tests Useful In Pancreatic Cancer Therapy

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PharmaCyte Biotech Inc (OTCMKTS:PMCB) has said that the cells it is planning to use in the clinical trial in patients suffering from locally advanced, non-metastatic inoperable pancreatic cancer (LAPC) have passed the 29 tests made mandatory by the U.S. Food and Drug Administration (FDA). Similarly, the clinical stage biotechnology company engaged in developing targeted technology cellular therapies for diabetes and cancer also announced that its signature live-cell encapsulation technology, Cell-in-a-Box capsules has also passed the FDA required “pore size studies.”

PharmaCyte Conducted Series Of Experiments

PharmaCyte had to provide specific data to FDA that revealed that the size of the pores in the Cell-in-a-Box capsules’ outer shell was of the right size for allowing the entry of ifosfamide in the interior of the capsules where the ifosfamide-activating cells are located. This experiment was a part of the Investigational New Drug Application (IND) process of the company that is required to be carried out prior to conducting a clinical trial in patients suffering from LAPC.

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As per the FDA rules, it was also necessary for PharmaCyte to demonstrate that the pore size remains unaffected even when the capsules are thawed or frozen during the experiment. And for that, the company conducted a series of laboratory experiments on the non-frozen and freshly thawed capsules.

While explaining the importance of this experiment, the Chief Executive Officer of PharmaCyte, Kenneth L. Waggoner said that this particular treatment for LAPC uses genetically engineered live human cells producing potent cytochrome P450 enzyme which activates prodrug ifosfamide given during chemotherapy. Waggoner said, “These cells are encapsulated using the Cell-in-a-Box® technology, and the capsules are implanted near the cancerous tumor so that a high local concentration of the cancer-killing ifosfamide metabolite is produced near the tumor.”

PharmaCyte Pass 29 Tests Made Mandatory By FDA

The cells that are going to be used for encapsulation in the company’s upcoming clinical trial for patients with LAPC has passed all the 29 tests made mandatory by FDA. As per the report, most of the tests were carried out by Eurofins Lancaster Laboratories, Inc. (Eurofins), the contractor of PharmaCyte and its third party laboratories. According to Waggoner, the tests carried out by its subcontractors were complex and varied and derived positive results. Hence, it is expected to get a final Certificate of Analysis in the coming week after which the company can begin the process of cell encapsulation.

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