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Sunday, May 20, 2007 5:04:15 PM
Interesting question, Geoge.
It is not uncommon for trials to continue to enroll for extended periods of time. You will note from the original announcement that no specific trial size was specified. You might also review the dates of various other clinical trial announcements for trials that continue to be open for enrollment. You will note that it is a common practice to keep such programs open and enrolling for an extended period of time:
http://www.entremed.com/go.cfm?do=Page.View&ID=137
For example, Entremed’s MKC-1 multi-center trial was announced 1/25/06 and is still open for enrollment.
In my opinion, the fact that a trial continues to be open for enrollment cannot be construed as anything less than encouraging. I can’t imagine that Dr. Blackwell would appreciate the intrusions of having to field calls from doctors across the country regarding enrollment unless she viewed the ongoing results as at least promising.
Dr. Folkman has commented that the true effectiveness of 2ME2 will be demonstrated in combination with other treatments. The trial in question evaluates Panzem NCD in combination with paclitaxel, both as to effect on tissue and plasma compared to Taxol alone, and as to safety and tolerability of Panzem in combination with weekly paclitaxel.
I would guess that for the trial to continue to be open, safety and tolerability have be satisfactorily demonstrated, and that the ongoing effort is to thoroughly evaluate effects on tissue and plasma.
Best regards.
Notes:
About Dr. Blackwell:
http://www.dukehealth.org/physicianspotlights/physician_spotlight_20031130212653393
Entremed’s announcement of Panzem NCD clinical trial for breast cancer:
http://www.entremed.com/download/press/DukeBCP1b_FINALOUT.pdf
It is not uncommon for trials to continue to enroll for extended periods of time. You will note from the original announcement that no specific trial size was specified. You might also review the dates of various other clinical trial announcements for trials that continue to be open for enrollment. You will note that it is a common practice to keep such programs open and enrolling for an extended period of time:
http://www.entremed.com/go.cfm?do=Page.View&ID=137
For example, Entremed’s MKC-1 multi-center trial was announced 1/25/06 and is still open for enrollment.
In my opinion, the fact that a trial continues to be open for enrollment cannot be construed as anything less than encouraging. I can’t imagine that Dr. Blackwell would appreciate the intrusions of having to field calls from doctors across the country regarding enrollment unless she viewed the ongoing results as at least promising.
Dr. Folkman has commented that the true effectiveness of 2ME2 will be demonstrated in combination with other treatments. The trial in question evaluates Panzem NCD in combination with paclitaxel, both as to effect on tissue and plasma compared to Taxol alone, and as to safety and tolerability of Panzem in combination with weekly paclitaxel.
I would guess that for the trial to continue to be open, safety and tolerability have be satisfactorily demonstrated, and that the ongoing effort is to thoroughly evaluate effects on tissue and plasma.
Best regards.
Notes:
About Dr. Blackwell:
http://www.dukehealth.org/physicianspotlights/physician_spotlight_20031130212653393
Entremed’s announcement of Panzem NCD clinical trial for breast cancer:
http://www.entremed.com/download/press/DukeBCP1b_FINALOUT.pdf
