Phase IIb trial of an encapsulated cell therapy product [NovaCaps] for advanced, inoperable pancreatic cancer
Phase of Trial: Phase II
Latest Information Update: 13 Feb 2017
At a glance
- Drugs Ifosfamide (Primary) ; Microencapsulated CYP2B1-expressing cells PharmaCyte Biotech (Primary) ; Fluorouracil; Folinic acid
- Indications Pancreatic cancer
- Focus Adverse reactions; Registrational; Therapeutic Use
- 13 Feb 2017 According to a PharmaCyte Biotech media release, the company is working finalize the number of patients that will be included in the trial and to complete the adjustments necessary for a newly designed trial
- 13 Feb 2017 According to a PharmaCyte Biotech media release, in the company's pre-IND meeting with the FDA, the FDA stated that it would be willing to change the company's clinical trial from an exploratory trial to a pivotal trial under certain conditions. The FDA indicated that if the therapy shows real promise, includes a sufficient number of patients and includes primary endpoints of overall survival and safety rather than progression free survival and safety, the trial may be considered a pivotal.
- 13 Feb 2017 According to a PharmaCyte Biotech media release, the company has discussed the comparator arm for this trial and it has been finalised that the company's pancreatic cancer therapy will be compared to is the combination of the cancer drug 5-fluorouracil (FU) and the compound leucovorin (LV).