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Tuesday, August 04, 2015 2:09:23 PM
They have shown safety only, all they need to move forward to next phases for K. Says NOTHING about efficacy. -TIAB
"Safety only"? That's a Primary Outcome Measure and a win for Phase 1. A Phase 1 success leads to Phase 2 in which efficacy is tested along with dose optimization is seeking a therapeutic dose. Phase 1 is a dose escalation safety trial. Moving to Phase 2 generally results in higher share prices. We have a likely win here.
My guess- and it is just a guess-would be more probable than not that it has some benefit, based on what Leo has said. But he has said so little. And last ASCO said nothing about efficacy. -TIAB
That is false. The last ASCO poster noted the increase in P21 as an indication of P53. That is tied in with efficacy and was why the principal investigator did an unusual second ASCO poster for a trial in progress.
Also what's been said before, Ovarian Cancer Spleen Mets disappearance, tumour and biomarker stabilizations, are all indications of efficacy and all one expects from a Phase 1 trial. Obviously there is more, the clues being the focus of Ovarian Cancer, the planned jump to Phase 2/3 and the securing of orphan drug status.
How much benefit, and for how many cancers, is what counts, and we are a long way from knowing. -TIAB
Yes, we will wait for Phase 2 or Phase 2/3 for an actual look at benefit. This is how clinical trials work, in stages. Read up on it or discuss with some colleagues who do research clinical trials and you'll have more realistic expectations.
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UNLESS CTIX and Dana Farber know things they are not saying, but I doubt this. -TIIAB
Of course they know things they are not saying, we've heard only tidbits. The focus on gynecological cancers and talk of an accelerated next trial for Ovarian Cancer are obvious clues, as are the P21 data to date.
However, let's consider how this science is done. This is a Phase 1 trial, period. It is not powered for determinations of efficacy, nor is the dose or frequency of dosing optimized. Any efficacy results are considered preliminary and used to guide later stage trials. It seems you are not understanding how Phase 1 trials work and expect Phase 2b results?
Kevetrin is a near certain success for its Phase 1 Primary Outcome Measures. That is the reality.
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