PharmaCyte Biotech on Schedule for 2016 Cancer Clinical Trial in Pancreatic Cancer
25 FEB 16
SILVER SPRING, Md., Feb. 24, 2016 (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®, issued a further update on its upcoming clinical trial in pancreatic cancer. In this update, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, clarifies statements made earlier this week that reportedly confused numerous shareholders and potential investors.
“Last Monday I tried to address certain issues that shareholders and potential investors have raised repeatedly about our upcoming clinical trial and provide an update on our efforts to complete the process of preparing the Investigational New Drug application (IND) that PharmaCyte must submit to the FDA to start our clinical trial in pancreatic cancer. Given the number of telephone calls and emails the Company has received since that update was published, it has become apparent that the update caused confusion and raised issues of concern that were never intended.
“When it was stated on Monday that the expected ‘start date’ for PharmaCyte’s clinical trial in pancreatic cancer remains difficult to announce with certainty, we were not implying that we aren’t still on schedule to get into the clinic in 2016 or that we don’t have any idea when we will be in the clinic. We plan to be in the clinic well before the end of this year. It was simply a statement that intended to refrain from announcing a specific date or time period for starting the trial because much of what is left to complete is out of our control.
“PharmaCyte is involved in a well-planned, detailed and methodical process to insure that every aspect of the IND is correct before we submit the IND to the FDA. As the “Sponsor” of the IND, it is our responsibility to insure that the Chemistry, Manufacturing and Controls (CMC) section of the IND is complete and accurate in every respect. We are working with Translational Drug Development (TD2), Chamow & Associates (Chamow) and Austrianova in completing everything that is required. It is a process that began last year and is well underway.
“TD2 is fully engaged and working diligently in all aspects of preparing for the clinical trial. With respect to developing the CMC information, the process is complicated, labor intensive and highly technical. But with TD2 taking the lead, working in concert with Chamow and Austrianova, I am very confident that our schedule is on track.”
