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Past timeline from RMZport: rmzport Member Leve

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Post# of 72451
(Total Views: 582)
Posted On: 06/19/2017 2:37:08 PM
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Posted By: someconcerns
Re: AlanC #34992
Past timeline from RMZport:

Quote:
rmzport Member Level Monday, 06/19/17 06:27:48 AM
Re: DesireToLearn post# 186328
Post # of 186429

Partial list. Dates correspond to Co press releases.

K= kevetrin B= brilacidin P= prurisol

CTIX Clinicals, FDA, Milestones

10/5/12 K Ph1 starts

1/24/13 K renal, in vivo combo w/sunitinib, first ever tumor shrinkage witnessed

6/26/13 K MD Anderson, Multiple Myeloma and Lymphoma

9/9/13 Acquired PolyMedix assets

2/25/14 B/ABSSSI Ph2b trial commences

3/24/14 P Ph1 crossover study starts

6/23/14 B Candida, Fox Chase Med collab/SBIR $1.5 mil Grant

8/7/14 B/ABSSSI meets Ph2b endpoints

10/13/14 B/Oral Mucositis (OM) Ph2 trial to commence

12/10/14 B/ABSSSI granted FDA 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 granted FDA OrphanDrug Designation for Retinoblastoma (eye cancer)

11/25/15 B/OM granted FDA Fast Track Designation

12/1/15 K granted FDA "Rare Pediatric Disease Designation" for Retinoblastoma

1/21/16 K granted FDA Orphan Drug 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

5/24, 5/26, 5/31/16 P ph2a successful trial data released (IGA score of 0/1=PASI 90 score)

6/6/16 K ph1 hard lock of data

6/9/16 Rosen/scam lawsuit dismissed by court.

6/15/16 B ph2 ulcerative proctitis 6 week duration overseas trial begins

6/30/16 Arthur P. Bertolino, MD, PhD, MBA, appointed President and CMO

8/30/16 Expansion of Senior Management Team adding Jane Harness,MS, MP

9/16/16 Expansion of Senior Management Team adding LaVonne Lang, DrPH

10/10/16 B ph2 ulcerative colitis/proc (UP), early results 100% and 50% reduction

10/31/16 P ph2b trial begins

1/23/17. B-UP corp update, 2nd cohort prelim observations

2/9/17 K initiation of ph 2 trial , ovarian cancer

2/9/17 K Oral delivery formulation testing commences

2/16/17 Review of expected 2017 clinical milestones

2/22/17 B-UP, ph 2 trial, 3rd cohort commences

2/27/17 CEO update on criminal Rosen/Mako pursuit.

3/3/17 K oral formulation and Leukemia lab studies in Italy updated

3/8/17 B-UP, ph 2 trial, Positive 2nd cohort results released (50%@100% and50%@66%)

3/21/17 B-UP, ph2 expanded favorable data from cohort 2

3/27/17 B-OM Great interim study data. Trial conclusion expected this year.

Conf call ?’s Still focused on being REGN like?

5/18/17 “B- for UP/UPS is well-positioned to become first-in-class.” Ph 2 recruiting complete

5/30/17 K Italy study of AML, Leukemia presenting preclinical findings 6/22-25/17




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