Posted On: 07/30/2016 7:34:49 AM
Post# of 72447
K= kevetrin B= brilacidin P= prurisol
CTIX Clinicals, FDA, Milestones
10/5/12 K Ph1 starts
1/24/13 K in combo w/sunitinib "first ever tumor shrinkage noted"
10/9/13 Acquired Poly assets
2/24/14 B/ABSSSI Ph2b starts
3/24/14 P Ph1 crossover study starts
8/7/14 B/ABSSSI meets Ph2b endpoints
10/13/14 B/OM Ph2 approval to commence
12/10/14 B/ABSSSI granted QIDP designation
12/10/14 P Ph2 start approved by FDA
5/22/15 K Ph1 allowed additional patient enrollment
7/20/15 K granted OrphanDrug Designation for Ovarian cancer
8/6/15 P Ph2 commences
11/23/15 K for Retinoblastoma (eye cancer) receives OrphanDrug Designation
11/25/15 B/OM granted FDA Fast Track Designation
12/1/15 K granted "Rare Pediatric Disease Designation" for Retinoblastoma
1/21/16 K receives Orphan Drug (FDA) Designation for Pancreatic Cancer
Applying for grants with research partner ?Mayo Clinic?
2/10/16 K approved for Ph2 ovarian cancer trial
2/16/16 K Ph1 trial formally concludes
2/22/16 K Ph1 early data-Increased p21 Expression in 67.5% of Evaluable
Patients
3/17/16 P ph2 last patient dosed
5/31/16 P ph2 successful trial data released
6/9/16 K ph1 "soft lock" of data
6/10/16 Rosen/scam lawsite dismissed by court.
6/15/16 B ph2 ulcerative proctitis (UB) 6 week duration overseas trial begins
7/18/16 B ph2 ulcerative proctitis (UB) 1st patient dosed reports
"amazing" results 1st week
CTIX Clinicals, FDA, Milestones
10/5/12 K Ph1 starts
1/24/13 K in combo w/sunitinib "first ever tumor shrinkage noted"
10/9/13 Acquired Poly assets
2/24/14 B/ABSSSI Ph2b starts
3/24/14 P Ph1 crossover study starts
8/7/14 B/ABSSSI meets Ph2b endpoints
10/13/14 B/OM Ph2 approval to commence
12/10/14 B/ABSSSI granted QIDP designation
12/10/14 P Ph2 start approved by FDA
5/22/15 K Ph1 allowed additional patient enrollment
7/20/15 K granted OrphanDrug Designation for Ovarian cancer
8/6/15 P Ph2 commences
11/23/15 K for Retinoblastoma (eye cancer) receives OrphanDrug Designation
11/25/15 B/OM granted FDA Fast Track Designation
12/1/15 K granted "Rare Pediatric Disease Designation" for Retinoblastoma
1/21/16 K receives Orphan Drug (FDA) Designation for Pancreatic Cancer
Applying for grants with research partner ?Mayo Clinic?
2/10/16 K approved for Ph2 ovarian cancer trial
2/16/16 K Ph1 trial formally concludes
2/22/16 K Ph1 early data-Increased p21 Expression in 67.5% of Evaluable
Patients
3/17/16 P ph2 last patient dosed
5/31/16 P ph2 successful trial data released
6/9/16 K ph1 "soft lock" of data
6/10/16 Rosen/scam lawsite dismissed by court.
6/15/16 B ph2 ulcerative proctitis (UB) 6 week duration overseas trial begins
7/18/16 B ph2 ulcerative proctitis (UB) 1st patient dosed reports
"amazing" results 1st week
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