Replies to post #7844 on Entremed (ENMD)

[RRGY2K]

A positive spin on a negative result is a time honored tradition, but nobody but the shorts could be "pleased" about reaching the death of half the patients in a study. In fact, one could argue that this news release was deceptively trying to suggest success from a failed trial if that were the case.

I think we need to ask them to clarify this point!

[compost]

"We are now considering whether to continue the current study or pursue additional options such as a randomized Phase 2 study in patients with non-small cell lung cancer. We will continue to collect data over the next few months from patients participating in this trial to determine the most efficient path forward in this indication."
In my opinion these statements by Dr Sidor make it sound positive. She offers the choice of continuing the current study or changing to a more advanced study. There wasn't any option listed for closing the study.....
She indicates in the second sentence that they see the need to move 'forward in this indication'. Again, in my opinion, I can't imagine 'moving forward' would include abandoning this population.
On the other hand, regardless of the results of this trial so far, we are still on the brink financially. This news doesn't do anything to change that.

[compost]

"... determine the antitumor activity, based on the objective response rate and median Progression Free Survival ("PFS")...".
In that case, the endpoint is met when half of the patients progress or die.
Is there not a possibility; albeit less likely, that there was a positive objective response rate? That is, some positive, significant change in the state of their disease or reduced median progression of that disease?
I find that the quote Dr. Sidor allowed to be attributed to her makes for uncomfortable reading: "We are pleased to have met the primary efficacy endpoint in the first stage of this study."
A positive objective response rate would certainly make Dr Sidor’s statement less uncomfortable, would it not?

I’m only trying to be hopeful here.

[docaaron1]

C-Peptide thanks for the clarification of the press release. I was a bit confused myself. Was the MKC-1 trial a dose escalating trial? If so, could it be that the earlier patients had doses too low and as the trial continued the dose levels were raised and hopefully the patients lived longer. I guess we will have to wait for the data.

Aaron

[compost]

At the risk of beating this horse to death

From CP’s message earlier today According to the trial description at clinicaltrials.gov ( http://www.clinicaltrials.gov/ct/show/NCT00408226 ), the trial will "... determine the antitumor activity, based on the objective response rate and median Progression Free Survival ("PFS")...".

Having reread today's release, I believe they are referring a more narrow definition.
From today’s press release
Patients were subsequently enrolled into the Phase 2 portion where the primary endpoint was tumor response.

[compost]

I just can't stop beating this dead horse
From the latest powerpoing presentation, slide 14, a variety of study 'endpoints' are listed which include 'progression free survival time' and 'duration of response and time to response'. Then immediately below it 'Primary endpoint (response) has been met'.

Based on what I've read so far it does not appear that progression free survival is the endpoint i.e. half the patients have had objective progression of their or have died as CP suggests.

[compost]

I think I’ll kick this dead horse now
I finally got around to listening to Jim Burns’ Nov 11 presentation.
Regarding MKC-1 endpoint met
overall response rates in excess of what you’d expect from Alimta alone
Regarding ENMD 2076 he very specifically commented
Intense partnering discussions
maintaining previous guidance of partnering by middle of next year