The development of PBI-05204 starts with growth and harvesting of Nerium oleander from a dedicated farm in Texas that utilizes the latest in organic techniques. Leaves from the plant are then broken into smaller pieces using a patented hands-free centrifugal force separation methodology prior to shipment to a company in Germany. There the leaves undergo extraction using a supercritical CO2 process which provides a means of extracting pharmacologically active ingredients without the use of toxic organic solvents. The extract then undergoes a specific formulation process that maximizes oral absorption. The finished product is placed into capsules. PBI-05204 has undergone extensive preclinical testing and has completed a formal Phase I clinical trial in heavily pretreated cancer patients at the University of Texas M. D. Anderson Cancer Center as well as a Phase II trial in advanced pancreatic cancer patients.
Results from these trials were encouraging and suggest the need for further clinical evaluation of this product against specific types of malignant disease. PBI-05204 has been examined for relative activity in vitro against different patient derived tumor biopsy samples. These tumor biopsy samples are grown as tumor spheroids in culture and provide a facile way of determining which tumor types might be most responsive to treatment with this product. Analyses of patient derived tumor samples exposed to PBI-05204 are highly encouraging and suggest that many different types of tumors may be responsive to this drug.