CTtrials site
Posted: Thu Jun 23, 2016 10:08 pm
Both Janssen trials updated yesterday. bp
Very interesting! There are some changes to the protocol of IMerge. They skipped the following sentence completely: "../.. in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment.".
The following sentence has been removed too:
"phase (until disease progression, or unacceptable toxicity, or withdrawal of consent, or lack of response)".
I consider these changes in the protocol as an important sign that they have good reasons for making imetelstat available to the a broader group of MDS patients population. That can only be based on a certain level of success so far and with the consent of the FDA.