Because of the overwhelming response to my earlier post on PRI724, I wanted to clarify a little bit more about this trial and other trials available for patients with advanced colorectal cancer who have received all standard of care regimens including FOLFOX, FOLFIRI, Avastin and Erbitux (if they were wild-type KRAS).
Of course we will have PRI724. The reason we are so excited because it is the first in class to inhibit a pathway so essential for colon cancer stem cells.
The IND is filed at the FDA, which means we need to wait 30 days for the FDA to respond. If they have concerns, we need to answer them. When they agree, we will go ahead to get institutional review board (IRB) approval. We already have scientific approval from the Cancer Center Scientific Review. Once we have IRB approval we are ready to go.
In the first phase any solid tumor is eligible. However, phase I trials are heavily regulated, so patients need to meet eligibility criteria, which means almost normal function of renal, liver, blood etc. They have to be in reasonable shape (able to do their daily activities). We anticipate that this trial may open at the beginning of November. Read the rest of this entry »