Replies to post #17845 on Innovation Pharmaceuticals Inc (IPIX)

[TheProgressive]

Glad it still being put to use, here is a slightly more updated one with cohort start dates if youd like to use that, thanks umiak!

KEVETRIN PHASE 1 CLINICAL TRIAL DATA POINTS AND TIMELINE - REPOST FOR NEWER MEMBERS

With the trial underway, here is a chronological summary of phase 1 trial data points and measures:


Primary Outcome Measures:
Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ]
Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ]


COHORT 1 -DAY 1 TO TAKE PLACE ON/AROUND, NOV 1ST, 2012 (WITHIN A FEW DAY WINDOW)


COHORT 2 - DAY 1 TO TAKE PLACE ON/AROUND , DEC 15TH, 2012 (WITHIN A FEW DAY WINDOW)

COHORT 3 - DAY 1 - TO BE DETERMINED

Secondary Outcome Measures:

DAY 1 :
Pharmacokinetic Profile of Kevetrin [ Time Frame: Day 1 Pre-dose, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion ]

DAY 1 :
Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 7 hours ]

DAY 1 :
Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 24 hours ]

DAY 15 :
Pharmacokinetic Profile of Kevetrin [ Time Frame: Day 15 Pre-dose, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion ]

DAY 30 :
Decrease in serum tumor marker [ Time Frame: baseline and 1 month ]


DAY 60 :
Change in tumor size [ Time Frame: baseline and 2 months ]

DAY 60 :
Decrease in serum tumor marker [ Time Frame: baseline and 2 months ]

DAY 90 :
Decrease in serum tumor marker [ Time Frame: baseline and 3 months ]

DAY 120 :
Change in tumor size [ Time Frame: baseline and 4 months ]

DAY 120 :
Decrease in serum tumor marker [ Time Frame: baseline and 4 months ]

DAY 150 :
Decrease in serum tumor marker [ Time Frame: baseline and 5 months ]

DAY 180 :
Change in tumor size [ Time Frame: baseline and 6 months ]

DAY 180 :
Decrease in serum tumor marker [ Time Frame: baseline and 6 months ]




That sums it up. That is what we will learn, and in proper chronological order. Very exciting, the will be trial data on a regular basis, lots of talking points and PR material

[buccaneer1961]

info from these things coming soon!


DAY 60 :
Change in tumor size [ Time Frame: baseline and 2 months ]

DAY 60 :
Decrease in serum tumor marker [ Time Frame: baseline and 2 months ]