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Pharmacyte Biotech Inc (OTCMKTS:PMCB)’s Clinical Trial Product To Treat LAPC Passes All The Release Tests Required By The US FDA And Ready IND Application Submission



Pharmacyte Biotech Inc (OTCMKTS:PMCB) is excited to announce that its clinical trial product has passed all the release tests required by the US FDA and ready for submission to the FDA for an investigational drug application. The company seeks the UD FDA approval to proceed with the Phase 2b clinical trial of its trial product, which is developed to treat locally advanced, pancreatic cancer in patients across the US.

Two batches of clinical trial products

More than two batches of the clinical trial products of Pharmacyte have undergone series 10 release tests and passed all the tests and qualify for phase 2b clinical trial. The cell-in-a-box, the signature live-cell encapsulation technology, has performed well and proven to be safe for administering to humans during the clinical trial. Over 20,000 genetically modified live cells that fit a cell-in-box capsule have functioned as expected during the tests. They are produced, kept in the syringes and frozen, and tested for cell viability, enzymatic activity, and biologic activity.

Receives certificates of analysis

Pharmacyte will receive two certificates of analysis from Austrianova because the clinical trial products have passed all the release tests. The company will also get all the completed batch records for the production runs and subsequent release testing. It needs to enter data generated from these tests for submission to the US FDA for the IND application.

To achieve success after submission of IND to the US FDA, Pharmacyte has taken two steps. In the first step, the company has manufactured and tested two batches of the clinical trial products as required by cGMP validation. The company takes responsibility for releasing the product into the US for a clinical trial.

Kenneth L. Waggoner, Chief Executive Officer of Pharmacyte, said its GMP consultant has informed that two manufacturing runs are not necessary to request a phase 2b clinical trial from the FDA. However, the two manufacturing runs demonstrate to FDA that its production process is robust and maintains the qualities.

Pancreatic cancer is the third leading cause of death in the US. Pharmacyte has put in significant efforts to ensure perfection in the process and engage with the FDA to get an opportunity to begin a clinical trial.

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