PharmaCyte Biotech Inc (PMCB)

[Peacefulwendy]

I think those concerns are addressed with the current trial design.

"Major factors in the overall trial design are:

-The clinical trial will be international (United States, Europe and possibly Australia), multi-site, open-label and randomized.
-Study sites under consideration in the United States include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center and the Dana-Farber Cancer Institute both in Boston, Massachusetts, the Baylor Cancer Center in Dallas, Texas, the City of Hope Cancer Center in Los Angeles, California, and sites in Germany and Spain.
-The randomization ratio of patients between the two study groups will be 1:1 (an equal number of patients will be randomly assigned to the capecitabine + radiation group and the PharmaCyte pancreatic cancer therapy group).
-As many as 84 patients will be required to complete the study, although fewer may be required based upon the data developed during the trial.
-Only patients who have locally advanced, non-metastatic, inoperable cancers and whose tumors no longer respond after 4-6 months of treatment with either the nab-paclitaxel (Abraxane®) + gemcitabine or FOLFIRINOX regimens will be eligible for the study.

Unlike the earlier clinical trials using PharmaCyte’s pancreatic cancer therapy where patients received only two doses of ifosfamide, multiple cycles of ifosfamide will be given to those being treated with PharmaCyte’s pancreatic cancer therapy. This will continue until the patients’ tumors no longer respond to PharmaCyte’s therapy or until treatment-related toxicity accumulates to unacceptable levels."

http://pharmacyte.com/pharmacyte-biotech-finalizes-design-of-pancreatic-cancer-clinical-trial-and-identifies-trial-sites-under-consideration/