Posted On: 11/12/2015 10:53:42 AM
Post# of 72444
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 )
(0)
(0)
If you try to defend yourself against lies of the board moderators your post will be deleted. Just like the board they claim to be better than!!! Watch who you trust especially the "long term investors" that support the real attackers!
Scroll down for more posts ▼
