Monday, April 04, 2016 6:21:44 PM
Q2 2016 Potential Catalysts
- P top-line data (Phase 2)
- B-OM interim data (Phase 2)
- K top-line data (Phase 1)
- Start of B-ABSSSI (Phase 3)
- Start of B-UP (Phase 2, proof of concept)
- Start of K-ovarian (Phase 2)
- Fast track designation for B-ABSSSI
- ASM Microbe presentations (June 19-20)
Past Milestones
- QIDP designation for B-ABSSSI
- Fast track designation for B-OM
- Orphan drug designation for K-ovarian cancer
- Orphan drug designation for K-pancreatic cancer
- Orphan drug designation for K-retinoblastoma
- Rare pediatric disease designation for K-retinoblastoma
- B-ABSSSI positive Phase 2b top-line & bottom line data
- Completion of cohort 11 (750 mg/m2)
- K positive primary outcome (Phase 1)
- P positive primary outcome (Phase 1)
- Stable formulation of B at room temperature
- MTA extension on testing B in implanted devices
Clinical Trials
1. P (Phase 1, completed): https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=1
2. P (Phase 2, not recruiting): 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
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
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