Replies to post #5558 on Entremed (ENMD)

[helpwantedhelpwanted]

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

[gooober]

am i to take taht you suspect the results aren't so good?

[docaaron1]

George, while 15 trial patients may not sound like a lot it may be hard to fill the group. I heard Dr. Blackwell interviewed on a webcasted site encouraging women to sign up for trial studies. She sounded very hopeful that the next five years will bring major breakthroughs in breast cancer drugs. She was just talking about experimental breast cancer drugs in general but it did sound like she was seeing good things in her trials.

I can’t find the link to the webcast but if someone finds it, please post it.

Aaron

[tborges]

It would seem that if significant positive results were occuring in the GBM or breast cancer PII trials, there would be a move by Entremed to move to PIII trials. After just 12 weeks and experiencing a 24% success rate with a an anti-inflammatory (interesting), Celgene announced they will be advancing the drug (CC1004)currently in psoriasis trials to a "broad range of inflammatory diseases."

And, Elan, yesterday announced a move into PIII trials in partnership with Wyeth prior to the conclusion and presentation of the data from the current PII trials for alzheimer treatment.

While the FDA must approve the trial design, it appears that the decision to enter into the next level of trials rests with the developer.

While I remain hopeful that there may be a similar announcement at the time of the ASCO presentations, it may be premature...