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Austrianova Singapore, A Partner Of Pharmacyte Biotech Inc (OTCMKTS:PMCB), Completes Final Production Run: Austrianova Ships Final Product For Release Testing



Austrianova Singapore, a partner Of Pharmacyte Biotech Inc (OTCMKTS:PMCB), has completed the second and final run of the GMP manufacturing process that will be used for the production of Pharmacyte’s clinical trial product. The clinical trial product of Pharmacyte is ready for release testing. The information collected from release testing in both the manufacturing runs would be included in the IND (an investigational new drug application). It will be sent to the US FDA for supporting the planned clinical trial of Pharmacyte in patients suffering from inoperable and advanced pancreatic cancer.

Austrianova ships frozen syringes for lab testing

Austrianova has filled the genetically modified live cells into clinical trial syringes of Pharmacyte and frozen. It has shipped a frozen syringe sample to Europe for release testing in a third-party lab. The lab will test the safety of the final release product. Austrianova will then conduct the functionality test of the live encapsulated cells in its in-house.

Kenneth L. Waggoner, CEO of PharmaCyte, said the company is excited to complete the two production runs. It is now ready to progress towards submitting IND to the US FDA to begin the clinical trial in inoperable and advanced pancreatic cancer.

Changes the future of curing diseases

The technology of Pharmacyte expects to make a change in the way several hard to cure diseases are treated soon. The company would offer a new lease of life to LAPC (locally advanced, inoperable pancreatic cancer) patients by reducing the size of the tumors by inching closer in its upcoming phase 2b clinical trial. The surgeons can safely remove the small tumors through surgery later.

With these clinical trials, Pharmacyte addresses the unmet medical needs of patients by shrinking the tumors. In the second instance, the clinical trial helps to validate the safety and effectiveness of the Cell-in-Box in humans.

Kenneth said the company is planning to change the way hard to treat diseases that are cured in the future by validating its technology in a clinical trial. It is continually developing new cell lines, mainly genetically engineered cell lines, to cure several diseases. The validation of Cell-in-Box removes the boundaries to treat diseases.

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