Wall Street Tea...'s  Instablog

Speculation has been rampant as to whether the recent moving out of the PICASSO III reporting event to Q1 2013 is a positive of negative. I believe this extension is an extreme positive per the rationale shown in the linked article below. Please take a minute to read through--the author has done an excellent job of laying out the bull thesis.

We know that the independent monitoring committee recently checked for safety and futility and reported their findings. All good on those fronts. Please note that the trial could not be stopped for efficacy. Only a pre-determined number qualifying events such as disease progression will end the trial . A Lack of sufficient events to halt trial means tumor progression (likely) must be occurring later in some patients(progression would qualify as event). We can assume the the control arm of dox plus placebo is tracking to its historical norm per some of Dr. Lewis' comments so the trial lengthening must be due to another factor. We also know IFOS works in many disease settings but that people are forced off drug due toxicity issues. Since Pali is essentially a derivative of IFOS with fewer side effects, people are likely able to tolerate the drug better and stay on treatment longer.

Others have contended that the delay is simply based on late enrollment. I believe that some of the delay is likely attributed to late enrollment but in a recent web cast, Doctor Lewis (Ziopharm's CEO) said the enrollment was fairly even throughout--NOT back-loaded. Again, Dr. Lewis clearly stated that enrollment was even across trial(NOT back-loaded). I tried to do the math but could only come up with one conclusion--- I believe trial extension can only be the result of the one unknown--ifos effects.

I found this summary on another site. Check out the author's conclusions. he seems to understand the science well and stats the case far more eloquently than I ever ever could. My bet remains that PICASSO III works and one day soon Palifosfamide will replace Ifosfamide in many disease settings. (Note: Ziopharm is also working on a SCLC trial with Pali).

http://propthink.com/ziopharm-palifosfamide-decision-delayed-what-does-this-mean-for-the-likely-outcome/3887

Disclosure: I am long ZIOP.