On January 27, 2020 PharmaCyte Biotech (OTCQB: PMCB) reported that its clinical trial product, which will be employed during the company’s upcoming Phase 2b clinical trial to treat locally advanced, inoperable pancreatic cancer (LAPC), has passed each of the U.S. Food and Drug Administration’s (FDA) required "release tests" for safety and functionality (Press release, PharmaCyte Biotech, JAN 27, 2020, View Source [SID1234553588]). With a clinical trial product that has proven to be safe and functional, PharmaCyte is now "on-the-clock" for its submission of an Investigational New Drug application or "IND" package to the U.S. FDA requesting a Phase 2b clinical trial in LAPC at trial sites throughout the United States.

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In a series of 10 "release tests" over two batches of the company’s clinical trial product for a total of 20 "release tests," PharmaCyte’s signature live-cell encapsulation technology, Cell-in-a-Box, performed admirably and proved to be both safe to place into humans in a clinical trial, and to function properly. During the tests, the more than 20,000 genetically modified live cells that fully fill each Cell-in-a-Box capsule were functioning as expected after being manufactured, placed into syringes, frozen, thawed and then tested for enzymatic activity, cell viability, and biologic activity among a host of other tests.

And now that "release testing" has ended successfully, Austrianova will issue 2 Certificates of Analysis to PharmaCyte—1 for each manufactured and tested batch of the company’s clinical trial product. Additionally, Austrianova will turn over all of the completed batch records to PharmaCyte from both production runs and the subsequent "release testing." The data generated from these tests are necessary information that must be entered into the company’s IND application.

PharmaCyte has methodically taken extra steps to position the company for a greater chance at success once the IND is submitted to the FDA. One such step is the manufacture and testing of two batches of its clinical trial product, which was requested by cGMP Validation, the company taking responsibility for releasing the clinical trial product into the U.S. for use in PharmaCyte’s upcoming clinical trial.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commenting on manufacturing a second batch of the company’s clinical trial product, said, "Our GMP consultant, cGMP Validation, has informed us that while two successful manufacturing runs are not required by the FDA to request a Phase 2b clinical trial, it could go a long way in demonstrating to the FDA that our manufacturing process is robust and reproducible – manufacturing qualities that are highly embraced by the FDA."

Successfully completing the manufacturing process of PharmaCyte’s clinical trial product, conducting and successfully completing "release testing" on both batches of the company’s product, and the data being generated from those tests are all critical to the completion of PharmaCyte’s IND package. With the announced success of the "release tests," PharmaCyte has essentially conquered what was the greatest hinderance in the company’s ability to move forward with completing its IND application.

Because pancreatic cancer is the third leading cause of cancer-related deaths, this work for PharmaCyte is important and necessary, and the company has painstakingly endured a process of perfection to land it on the precipice of engaging with the FDA in an opportunity to enter into a clinical trial. In 2020 alone, an estimated 57,600 Americans will be diagnosed with pancreatic cancer, and approximately 47,050 Americans are expected to die from the disease this year.

PharmaCyte hopes to better those dismal numbers by using its targeted chemotherapy—Cell-in-a-Box plus low doses of the anticancer drug ifosfamide—in patients with LAPC who no longer see any benefit after being treated for 4-6 months with one of the two first-line therapies offered to this patient population. Its stated goal is to make inoperable tumors operable and give these patients a second chance at life. Needless to say, PharmaCyte is closer than ever to submitting its IND, so the countdown to this momentous milestone for the company’s shareholders should be "officially" underway and is certainly highly anticipated.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, watch the company’s documentary video complete with medical animations at: View Source