Thursday, August 11, 2016 6:13:05 PM
Recent Interviews
- Interview with New Cellceutix President Dr A Bertolino
http://seekingalpha.com/article/3988240-interview-new-cellceutix-president-dr-bertolino
- Cellceutix Pipeline Continues to Hit Milestone After Milestone
https://www.streetwisereports.com/pub/na/cellceutix-pipeline-continues-to-hit-milestone-after-milestone
- A Small-Cap Biotech with Big Ideas for Acute Infections and Cancers: Cellceutix's Leo Ehrlich and Dr. Daniel Jorgensen
http://www.thelifesciencesreport.com/pub/na/a-small-cap-biotech-with-big-ideas-for-acute-infections-and-cancers-cellceutixs-leo-ehrlich-and-dr-daniel-jorgensen
H2 2016 Potential Catalysts
- B-OM interim data (Phase 2)
- B-UP interim data (Phase 2 POC)
- K top-line data (Phase 1)
- Start of K-ovarian (Phase 2)
- Start of P (Phase 2b)
Past Milestones
Kevetrin
- Orphan drug designation for K-ovarian cancer
http://cellceutix.com/cellceutixs-kevetrin-receives-fda-orphan-drug-designation-for-the-treatment-of-ovarian-cancer/#sthash.jPlU1TnV.dpbs
- Orphan drug designation for K-pancreatic cancer
http://cellceutix.com/cellceutix-receives-fda-orphan-drug-designation-for-kevetrin-for-the-treatment-of-pancreatic-cancer/#sthash.XUqZiRj0.dpbs
- Orphan drug designation for K-retinoblastoma
http://cellceutix.com/cellceutix-receives-fda-orphan-drug-designation-for-kevetrin-for-the-treatment-of-retinoblastoma/#sthash.0UlNePSd.dpbs
- Rare pediatric disease designation for K-retinoblastoma
http://cellceutix.com/cellceutix-receives-rare-pediatric-disease-designation-from-fda-for-kevetrin-for-the-treatment-of-retinoblastoma/#sthash.JjTjI8sG.dpbs
- Positive primary endpoint (Phase 1)
http://cellceutix.com/cellceutix-prepares-phase-2a-ovarian-cancer-trial-of-kevetrin-a-novel-p53-modulating-drug-candidate-based-upon-phase-1-topline-data/#sthash.OLEUr7N7.dpbs
Brilacidin
- QIDP designation for B-ABSSSI
http://cellceutix.com/cellceutix-antibiotic-brilacidin-receives-qidp-designation-from-fda/#sthash.h3WvWGbq.dpbs
- Fast track designation for B-OM
http://cellceutix.com/fda-grants-fast-track-designation-to-cellceutixs-brilacidin-om-for-oral-mucositis/#sthash.tGgpFvLG.dpbs
- B-ABSSSI positive top-line & bottom line data (Phase 2b)
http://cellceutix.com/cellceutix-announces-positive-top-line-data-from-phase-2b-absssi-trial-single-dose-brilacidin-comparable-to-7-days-of-daptomycin/#sthash.F9FLBVb3.dpbs
- American Society for Microbiology journal publication
http://aac.asm.org/content/early/2014/06/11/AAC.02955-14#corresp-1
- MTA extension for testing in implanted devices
http://cellceutix.com/cellceutix-completes-lab-testing-of-brilacidin-for-planned-phase-3-trial-for-acute-bacterial-skin-and-skin-structure-infections/#sthash.GKpiYemt.dpbs
- Formulation stable at room temperature
http://cellceutix.com/cellceutix-announces-breakthrough-in-the-formulation-of-its-novel-antibiotic-brilacidintm-plans-studies-to-treat-diabetic-foot-ulcers/#sthash.GbrZuqak.dpbs
Prurisol
- Positive top-line data (Phase 2a)
http://cellceutix.com/cellceutix-phase-2-trial-of-prurisol-for-mild-to-moderate-psoriasis-meets-primary-endpoint/#sthash.Xzje9gTP.dpbs
- Positive primary endpoint (Phase 1)
http://cellceutix.com/cellceutix-anti-psoriasis-drug-prurisol-meets-primary-endpoint-of-clinical-trial/#sthash.VQ1aMllD.dpbs
- 505(b)(2) pathway
http://cellceutix.com/cellceutix-informed-by-fda-that-505b2-application-would-be-an-acceptable-approach-for-its-psoriasis-drug-2/#sthash.tg0BHEyW.dpbs
Clinical Trials
1. P (Phase 1, completed)
https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=1
2. P (Phase 2, completed)
https://clinicaltrials.gov/ct2/show/NCT02101216?term=cellceutix&rank=2
3. B-OM (Phase 2, recruiting)
https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3
4. B-ABSSSI (Phase 2, completed)
https://clinicaltrials.gov/ct2/show/NCT02052388?term=cellceutix&rank=4
5. K (Phase 1, completed)
https://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=5
6. B-UP (Phase 2 POC, recruiting)
http://cellceutix.com/cellceutix-receives-update-on-first-patient-enrolled-in-phase-2-proof-of-concept-study-of-brilacidin-for-ulcerative-proctitis/#sthash.qAt5eSu9.dpbs
Abbreviations
K – Kevetrin
B – Brilacidin
P – Prurisol
ABSSSI – acute bacterial skin and skin structure infections
OM – oral mucositis
UP – ulcerative proctitis
QIDP – qualified infectious disease product
Pipeline
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
VPR Brands LP Reports Record Annual Financial Performance for Fiscal Year 2023 • VPRB • Apr 19, 2024 11:24 AM
Coinllectibles' Subsidiary, Grand Town Development Limited, Acquires Rare Song Dynasty Ceramics Worth Over USD28million • COSG • Apr 18, 2024 8:03 AM
ILUS Provides Form 10-K Filing Update • ILUS • Apr 17, 2024 9:54 AM
Glucotrack Announces Expansion of Its Continuous Glucose Monitoring Technology to Epidural Glucose Monitoring • GCTK • Apr 17, 2024 8:00 AM
Maybacks Global Entertainment To Fire Up 24 New Stations in Louisiana • AHRO • Apr 16, 2024 1:30 PM
Cannabix Technologies Begins Certification of Contactless Alcohol Breathalyzer, Re-Brands product series to Breath Logix • BLOZF • Apr 16, 2024 8:52 AM