.gif)
PharmaCyte Biotech, Inc., 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 announced that it will be meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) on Tuesday, January 17, 2017. The meeting is to discuss numerous aspects of PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commenting on the meeting said, “We are pleased that PharmaCyte will be starting out the New Year with a meeting with CBER. PharmaCyte has submitted a list of important questions to the FDA that will be essential to the design of our trial and how it is to be conducted. The questions also touch on the need for any additional information to be developed or submitted to the FDA before PharmaCyte files its Investigational New Drug application (IND). We are looking forward to CBER’s responses so that we can continue with our product development of an effective and safe therapy for LAPC.”
PharmaCyte recently submitted questions to the FDA as part of its pre-IND submission package. With answers to these questions and any additional information provided by CBER during the January 17 meeting, PharmaCyte will address any open issues or requests of CBER before preparing its IND. Once the IND is submitted and found to be acceptable to the FDA, PharmaCyte can proceed with its planned clinical trial in LAPC and enroll patients at the selected trial sites throughout the U.S.
PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature – with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of ifosfamide to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they become operable.
