Information Regarding Cellceutix, all credit goes
Post# of 72446
Posted On: 11/12/2015 10:53:42 AM
Information Regarding Cellceutix, all credit goes to Slcimmuno!
1) CLINICAL MILESTONES / CATALYSTS
Oncology
- Completion of K Phase 1 -- more details as to safety, efficacy; article has been submitted to a peer review journal for publication
- Initiation of several other K Phase 2, 2/3 trials -- ovarian, pancreatic, AML... this last one w/ Bologna on hold pending financing; in future trials, K to be evaluated as a monotherapy and as a combo therapy; more frequent dosing likely; pursuing grant support; additional Orphan designation/s likely
- Meeting w / FDA on K-pediatric retinoblastoma ; have submitted request to FDA for Rare Disease Designation
Infectious Disease / Antibiotics
- Start of B-ABSSSI Phase 3 -- Brilacidin represents a new class of ABX, Host Defense Protein (HDP)-Mimics; given as a single dose (in Ph 2 compared favorably w/Daptomycin); two trials, approximately 1400 patients btw them; also a Pediatric Study Plan submitted to FDA for use in children; eventual Fast-Track designation assigned, per QIDP; additional expedited pathway designations possible
- Phase 2 B-OM update (oral mucositis) -- great unmet need here; recruitment ongoing, additional enrollment sites being pursued
- ABX platform progress -- advancing work on anti-fungals (Candida species, aspergillus); anti-biofilm (MTA signed for B-prophylactic testing with a Big Rx); gram-neg compounds targeting Pseudomonas, Klebsiella, E. Coli, Acinetobacter. Carbapenem-resistant Enterobacteriaceae (CRE); GI indiciations, givien B's immunomodulatory properties (Ulcerative Proctitis/Colitis, H Supportiva); topical applications for Otic Infections
https://en.wikipedia.org/wiki/Brilacidin
Dermatology
- Phase 2 P update -- enrollment completion expected by end of 2015 (plaque psoriasis)
2) OPERATIONAL MILESTONES / CATALYSTS
- Financing in place (shelf, Aspire)
- 1st Shareholder meeting (Dec 15)
- NASDAQ uplisting (if $2 is maintained)
- Class Action Defense (Legal)
- Partners: likely farther off... Post Ph III ABSSSI for ABX... And will it be by indication or for whole platform? Kevetrin, the wildcard... As a case study, see CELG-Nurix deal (p53)
https://blogs.shu.edu/cancer/2015/09/30/ubiqu...d-celgene/
3) CURRENTCLINICAL TRIALS (PIPELINE)
Overall - https://clinicaltrials.gov/ct2/results?term=c...rch=Search
1. P (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT024944...amp;rank=1
2. B-OM (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT023243...amp;rank=3
3. K (Phase 1, recruiting): https://clinicaltrials.gov/ct2/show/NCT016640...amp;rank=4
4. B-ABSSSI (Phase 2, completed): https://clinicaltrials.gov/ct2/show/NCT020523...amp;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
Company Website: cellceutix.com
( Cellceutix, CTIX, #CTIX, $CTIX )
1) CLINICAL MILESTONES / CATALYSTS
Oncology
- Completion of K Phase 1 -- more details as to safety, efficacy; article has been submitted to a peer review journal for publication
- Initiation of several other K Phase 2, 2/3 trials -- ovarian, pancreatic, AML... this last one w/ Bologna on hold pending financing; in future trials, K to be evaluated as a monotherapy and as a combo therapy; more frequent dosing likely; pursuing grant support; additional Orphan designation/s likely
- Meeting w / FDA on K-pediatric retinoblastoma ; have submitted request to FDA for Rare Disease Designation
Infectious Disease / Antibiotics
- Start of B-ABSSSI Phase 3 -- Brilacidin represents a new class of ABX, Host Defense Protein (HDP)-Mimics; given as a single dose (in Ph 2 compared favorably w/Daptomycin); two trials, approximately 1400 patients btw them; also a Pediatric Study Plan submitted to FDA for use in children; eventual Fast-Track designation assigned, per QIDP; additional expedited pathway designations possible
- Phase 2 B-OM update (oral mucositis) -- great unmet need here; recruitment ongoing, additional enrollment sites being pursued
- ABX platform progress -- advancing work on anti-fungals (Candida species, aspergillus); anti-biofilm (MTA signed for B-prophylactic testing with a Big Rx); gram-neg compounds targeting Pseudomonas, Klebsiella, E. Coli, Acinetobacter. Carbapenem-resistant Enterobacteriaceae (CRE); GI indiciations, givien B's immunomodulatory properties (Ulcerative Proctitis/Colitis, H Supportiva); topical applications for Otic Infections
https://en.wikipedia.org/wiki/Brilacidin
Dermatology
- Phase 2 P update -- enrollment completion expected by end of 2015 (plaque psoriasis)
2) OPERATIONAL MILESTONES / CATALYSTS
- Financing in place (shelf, Aspire)
- 1st Shareholder meeting (Dec 15)
- NASDAQ uplisting (if $2 is maintained)
- Class Action Defense (Legal)
- Partners: likely farther off... Post Ph III ABSSSI for ABX... And will it be by indication or for whole platform? Kevetrin, the wildcard... As a case study, see CELG-Nurix deal (p53)
https://blogs.shu.edu/cancer/2015/09/30/ubiqu...d-celgene/
3) CURRENTCLINICAL TRIALS (PIPELINE)
Overall - https://clinicaltrials.gov/ct2/results?term=c...rch=Search
1. P (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT024944...amp;rank=1
2. B-OM (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT023243...amp;rank=3
3. K (Phase 1, recruiting): https://clinicaltrials.gov/ct2/show/NCT016640...amp;rank=4
4. B-ABSSSI (Phase 2, completed): https://clinicaltrials.gov/ct2/show/NCT020523...amp;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
Company Website: cellceutix.com
( Cellceutix, CTIX, #CTIX, $CTIX )
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