Monday, December 07, 2015 11:39:25 AM
December Potential Catalysts
- K top-line data (Phase 1)
- Orphan drug designation for K-pancreatic cancer
- Shareholders meeting (December 15, 2015)
Q1 2016 Potential Catalysts
- P top-line data (Phase 2)
- Start of B-ABSSSI (Phase 3)
- Fast track designation for B-ABSSSI
- Biotech Showcase (January 11-13, 2016)
- FDA meeting on K-ovarian cancer (Phase 2)
- B-OM update (Phase 2)
- Nasdaq uplist
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-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)
- P primary endpoint met (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. K (Phase 1, not recruiting): https://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=4
5. B-ABSSSI (Phase 2, completed): https://clinicaltrials.gov/ct2/show/NCT02052388?term=cellceutix&rank=5
Abbreviations
K – Kevetrin
B – Brilacidin
P – Prurisol
OM – oral mucositis
ABSSSI – acute bacterial skin and skin structure infections
QIDP – qualified infectious disease product
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