hercules, you #$%$, it is not mentioned there, but then you are too lazy and stupid to check yourself, easy to write your #$%$ here I suppose
Does anyone know if the criteria for FDA approval under Special Protocol Assessment is just Aldoxorubicin bettering Doxorubicin in P3STS or does Aldo have to do better all the other 5 therapies listed below) being compared ? Thanks
Dacarbazine administered at 1000 mg/m2 by intravenous infusion (IVI), over 90±15 minutes on Day 1 every 21 days until tumor progression or unacceptable toxicity occurs;
Pazopanib, 800 mg orally each day until tumor progression or unacceptable toxicity occurs;
Gemcitabine, 900 mg/m2 by IVI over 90 minutes on Days 1 and 8, plus docetaxel, 100 mg/m2 by IVI over 1 hour on Day 8 of a 28 day cycle until tumor progression or unacceptable toxicity occurs;
Doxorubicin, 75 mg/m2 by IVI over 5 to 30 minutes every 21 days for a maximum cumulative dose of 550 mg/m2 or unacceptable toxicity occurs; or
Ifosfamide 2.0 g/m2 administered over 2 to 4 hours on Days 1-4 of a 21 day cycle + mesna per standard site administration regimen until tumor progression or unacceptable toxicity occurs.
Whole comparison to Aldo is to 5 other drug regimns, fir approval all it needs it to best Aldo is that not true ? Can some add to thin as I am unable to get the right answer. Tks
Can anyone elaborate why CYTR chose to compare aldoxorubicin with multiple different regimes in addition to Doxorubicin ? Does that not make the bar extremely high ? I think just comparing Aldo with Doxo would have sufficient, . Now Aldo has to show superiority not only to Doxo but other drugs as well. Then why enroll patients who might have had Doxo already, patients with STS are tough to treat anyway, refectory more so.
Then, is the criteria of FDA approval going to be how Aldo fares vs Doxo or how Aldo fares with other drugs too ? For instance if Aldo does better than Doxo but does poorly vs the other 3 comparator regimes what would it mean for approval chances ?
It is quite possible that CYTR hits $5 on the run up before results by June, The abstract on May 18 should give the stock a impetus. I estimate an over 80% probability of a positive phase 3 STS data.
These abstracts are not related to STS P3, but if good abstract results ( as is expected going by Danile Levitt's statement), it would add to the expectation of good P3 STS results. Keep in mind that Phase 2b Randomized STS Clinical Trial published in Jama Dec 15, 2015 was positive, that adds to the expectation that the P3 STS should be good too.
CYTR's abstracts of 3 aldoxorubicin clinical trials will be presented on June 4, 5 and 6 at ASCO, but the abstracts will be available on-line on May 18. "Presenting the results from these three clinical trials at the ASCO Annual Meeting demonstrates the broad potential for aldoxorubicin and should raise awareness among oncologists," said Daniel Levitt, M.D., Ph.D., CytRx's EVP and Chief Medical Officer. "
Expect a boost in PPS on May 18.