PharmaCyte Biotech Announces Pre-IND Meeting Date with FDA
January 04, 2017 at 09:25 am
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PharmaCyte Biotech, Inc. 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 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.
PharmaCyte Biotech, Inc. is a biotechnology company. It is focused on developing cellular therapies for cancer, diabetes, and malignant ascites based upon a cellulose-based live cell encapsulation technology known as Cell-in-a-Box. Its product candidate is referred to as CypCaps. The Cell-in-a-Box encapsulation technology potentially enables genetically engineered live human cells to be used to produce various biologically active molecules. It is advancing clinical research and development of new cellular-based therapies in oncology and diabetes. It is also focused on developing therapies for pancreatic and other solid cancerous tumors by using genetically engineered live human cells. Its product candidate for the treatment of diabetes consists of encapsulated genetically modified insulin-producing cells. It is also focused on the benefits of the Cell-in-a-Box technology to develop therapies for cancer that involve prodrugs based upon certain constituents of the Cannabis plant.