A DOZEN REASONS TO BE CONFIDENT IN THE PICASSO 3 DATA....
Forget the inaccurate 20% RR quoted in a ZIOP piece, its patently inaccurate - the recent EORTC trial was 13%, the most recent was 9% and almost all the blinded independently monitored trials recently before those dox was in single digits....here's 12 reasons to be confident in the data
1) We know the trial could have achieved approvable endpoints in Q4
2) We know a trial that only needs 3 months PFS was extended 3 months.
3) We know the control arm drug dox is actually in BOTH arms including Pali + dox.
4) We know the extension was not due to timing of patient enrollment as that did not change from the previous interim review by the independent DMC which said it could halt Q4
5) We know what dox can and can't do and if you do enough due diligence you can get a hint that the extension is not likely due to the control arm drug outperforming what it ever has done before.
6) We know based on a Journal of Clinical Oncology Canadian study that Dox does not work as well in patients over 60.
7) We know the median age of the IFOS trial that everyone is taking dox numbers from was 49.
8) We know that the Picasso 3 Palifosfamide trial has a good number of patients over 60, where dox (control arm) does not work as well.
9) We know that one thing Dr Lewis is is a brilliant oncologist.
10) We know the quality of this trials steering committee.
11) We know with IFOS you have to also take Mesna for side effects - with Pali you don't - so even similar efficacy with less drop outs and side effects would seem enough but it appears we have much more.
12) We know that the Picasso 3 trial COULD HAVE stopped for futility - but didn't despite multiple interim reviews by the independent data monitoring committee. We know there is efficacy. And we know the trial COULD NOT in its protocol stop for great efficacy until the predetermined number of progression events hit, which just happened.
IF I WAS SHORT I WOULD BE GETTING VERY NERVOUS ABOUT NOW. Clearly these articles popping up (as well as the short grunt posts on yahoo and other boards) is a sign they are. There is a huge percentage of float short and you gotta believe Kirk and Fidelity will move their shares to non-borrowable when data comes out - similar pattern in previous companies like clinical data and new river. I know a number of people who will be doing the same.
I repost because of the inaccurate TSC article citing inaccurate response rates of dox. Even though its PFS and not response rates that are important, the fact that they overstated the RR % so much vs the most recent blinded dox trial will always get me to repost the facts that are important.
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP; $4.12)
Rating: MARKET OUTPERFORM
Price Target: $7.00
We View the PICASSO 3 Delay as Positive News
ZIOPHARM Oncology Inc. (ZIOP) yesterday announced that, after an analysis of progression-free survival (PFS) events by the Independent Data Monitoring Committee (IDMC) the palifosfamide PICASSO 3 trial in frontline metastatic soft tissue sarcoma (mSTS), the projected timing for the triggering event and announcement of top-line PFS results has been delayed from this quarter to the end of 1Q13. We believe the anticipated analysis of PFS in PICASSO 3 will be in favor of the palifosfamide treatment arm. With the shares currently at the lower end of values derived from our valuation analysis, we believe significant upside exists and reiterate our Market Outperform rating and 12-month price target of $7.
We View the Delay as Positive News PICASSO 3 is designed with 85% power to detect a 0.60 hazard ratio (HR) ratio PFS advantage with palifosfamide. The company designated PFS as the primary endpoint for accelerated approval, and designated overall survival (OS) as the endpoint for full approval. The update on the trigger event�s delay likely also delays the timing of top-line OS data release, and thus may be viewed by some investors as negative news. We had believed the timing of top-line PFS data release this quarter as aggressive and only modeled modest sales of Palifosfamide in 2014 ($12.9MM), with the expectation for 3Q14 accelerated approval and full approval gained in 2015. As the IDMC recommended that PICASSO 3 proceed as designed and conducted with no changes, we remain confident that PICASSO 3 will demonstrate a PFS benefit with palifosfamide.
We Recommend Using Share Volatility as an Entry Point The announcement of top-line PICASSO 3 PFS results is a binary event that we anticipate will be a key positive share driver. We recommend taking advantage of recently increased volatility (peaking up 177% since July) in ZIOP shares, and use current prices as an entry point for new positions.