"in the Ziopharm study, sarcoma patients treated with doxorubicin reported a median progression-free survival of 5.2 months. That's essentially the same median PFS reported by CytRx for the aldoxorubicin-treated patients."
Can you figure out the obvious significance of this and the shadow it casts on CYTRx's data? Peer review can question and lead to recall or restart of trial = BIG DELAYS, HUGE DOUBT, AND HUGE COSTS.
Sentiment: Strong Sell
Do you know that Ziopharm never submitted their Picasso III clinical data to the FDA? Do you know that in earler studies they had problems which caused renal failure in some patients and the dose had to be reduced for the Ph III study? Do you know that their own independent medical panel recommended that they continue their study to monitor the "overall survival" rate of the patients but that Ziopharm ignored that recommendation and cancelled Ph III totally? What I believe happened is that Ziopharm had safety issues with their drug and instead of reporting that as their reason for cancelling the clinical (because doing so would have brought into question the clinicals they were doing on other similar products) they decided to inflate PFS for Doxorubicin so that they could state they didn't meet their end poiints. Ziopharm's website has refereences to Doxo PFS as being approximately 3 months for several studies, which coincidentally matches the data from CYTR. I can pull a Adam F. and question, why did the Doxo perform SO WELL in Ziopharm's clinical testing which was more than 2 months longer than normal??? Seems to me that Ziopharm had the data that is in question, not CYTR.
From the Ziopharm website "In randomized studies where PFS is reported, single-agent doxorubicin has a short median PFS of about 3 months; thus there is an urgent need to improve upon the clinical efficacy of doxorubicin administered alone."....that datapoint is just as valid as the one your buddy used and closely matches that found in the CYTR study.
That's weird, last week you were pumping the stock and crowing that the drug works. Remember this?
I think you may have missed a very crucial detail. The Cytrx study was performed on patients that had already been through first line treatment. These patients have already been through treatment with the standby medication for the past 30 years (same molecule as aldoxorubicin but without the linker added). These patients didn't respond at all before or in the phase 2 study which is why it actually makes sense that 0% responded to the same old drug for a second time and yet Aldoxorubicin has a 6 month PFS OF 66.7%. Now tell me that isn't a winner.
owtside - you are incorrect - read the CYTR press release announcing the results - they state it is "first line" therapy. However, that is one of the problems with the way the trial was conducted - the enrollment criteria allowed prior "adjuvant" chemotherapy ( i.e. used in conjunction with surgery), including three cycles of Dox. Dox has a lifetime dose cap of 6 cycles, so I'm not sure how they could enroll any patient that had prior Dox therapy into a controlled trial where they would potentially be targeted to receive 6 cycles of Dox, if randomized into the placebo group. Combine this pseudo-front line issue with the trial sites in eastern Europe and Russia and it starts to seem a little flaky - why would you need to go outside the US to enroll a 105 patient trial?
Depends on the end points....how do you describe "progression free"....etc. By not reporting this material information Adam F. is in breach of conduct for a "journalist". Also, you cannot compare one group of studies to the next...that is why you study the Aldoxorubicin with the same double-blind conditions as the doxorubicin. Your posting of the manipulator's opinions are not newsworthy either....