PharmaCyte Biotech Inc (PMCB)

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KW Quote We all feel that the suggested changes we received from the FDA should not take long
did this meeting ever happen
13 FEB 17
LAGUNA HILLS, Calif., Feb. 13, 2017 (GLOBE NEWSWIRE) — PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today discussed the comparator arm for its upcoming clinical trial and provided additional clarification on its recent pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding its upcoming clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
In the company’s upcoming trial, the comparator arm that PharmaCyte’s pancreatic cancer therapy will be compared to is the combination of the cancer drug 5-fluorouracil (FU) and the compound leucovorin (LV). The necessary and quick decision was made by Dr. Manuel Hidalgo, the Principal Investigator for the upcoming clinical, Dr. Daniel Von Hoff with Translational Drug Development (TD2), the CRO for PharmaCyte’s clinical trial, and Dr. Matthias Löhr, the Chairman of PharmaCyte’s Medical and Scientific Advisory Board.
“After our pre-IND meeting I am more confident and enthusiastic than ever about PharmaCyte’s ability to validate its therapy for locally advanced, inoperable pancreatic cancer in a human clinical trial,” stated PharmaCyte’s Chief Executive Officer, Kenneth L Waggoner.
He continued, “And I am quite gratified that the FDA sees enough potential in our product to consider our trial a pivotal one under the right circumstances. Now the mission for our entire team is to work diligently towards the submission of our IND to the FDA. We all feel that the suggested changes we received from the FDA should not take long to make and will certainly be well worth it in the long run. For example, we quickly gained agreement on the comparator arm for the trial and, in doing so, we’ve moved closer to filing our IND with the FDA.”
PharmaCyte’s management, Dr. Manuel Hidalgo, TD2 and TD2’s consulting statistician are actively working to finalize the number of patients that will be included in the trial. This is the final element and will complete the adjustments necessary for a newly designed trial.