Sorry, here is the full post.Eight of the nineteen patients...

Sorry, here is the full post.
Eight of the nineteen patients enrolled in the 2-hour and 4-hour infusion groups of the Phase I clinical trial completed six cycles and as a result were invaluable for the Phase IIA component of the trial. Of the eight, three had significant partial responses. One of these patients with metastatic renal cell carcinoma has shown a LONG TERM DURABLE RESPONSE (>15 months). Of the other two significant partial responders, one patient passed away due to the long term effects of cancer (even though he had >50% tumour reduction) the other (NSCLC) is continuing to have stable disease and is experiencing good quality of life. It is important to note, one does not expect to see any response whatsoever in Phase I clinical studies.

“It is unusual to see radiological responses in a Phase I study. The documentation of two [such] patients in this study suggests that SBP002 does have potentially significant activity.”

Principal Investigator Professor Michael Millward,

Department of Medical Oncology

Sir Charles Gairdner Hospital

in response to the 2-hour infusion trial group.

The Phase I clinical trial was also designed to provide quality of life data (QoL) using the industry standard EORTC questionnaire. Results from the 2 hour infusion patients confirm that a significant portion of patients treated with Coramsine® showed improvement in QoL parameters usually negatively affected by cancer chemotherapy. It is important to note that the FDA now recognises palliation of symptoms associated with progressive disease as a viable endpoint for a clinical trial in advanced cancer patients.