1-26-16 $CTIX ~ Cellceutix Corp. Due Diligence Rep
Post# of 72440
Posted On: 01/26/2016 2:00:46 PM
1-26-16 $CTIX ~ Cellceutix Corp. Due Diligence Report
$CTIX recent news
PR's from Cellceutix:
http://www.cellceutix.com/category/press-rele...r967e.dpbs
PR's from Yahoo/Marketwired:
Mon, 25 Jan 2016 ~ Cellceutix Phase 2 Trial of New Oral Treatment for Psoriasis Nearing Completion
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...
read full: http://www.finance.yahoo.com/news/cellceutix-...00315.html
Fri, 22 Jan 2016 ~ Cellceutix Releases Data Used in Receiving FDA Orphan Drug Designation of Kevetrin for Pancreatic Cancer
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today released information ...
read full: http://www.finance.yahoo.com/news/cellceutix-...42403.html
Thu, 21 Jan 2016 ~ Cellceutix Receives FDA Orphan Drug Designation for Kevetrin for the Treatment of Pancreatic Cancer
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...
read full: http://www.finance.yahoo.com/news/cellceutix-...58464.html
January 19, 2016 ~ Cellceutix Submits Briefing Book for Phase 2 Trial of p53 Targeting Drug for Ovarian Cancer
[Marketwired] - Cellceutix Corporation (OTC: CTIX), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform......
read full: http://www.marketwired.com/press-release/cell...089125.htm
January 14, 2016 ~ Brilacidin Lyophilized as Cellceutix Prepares to Bring First New Class of Antibiotic to Phase 3 Trials in More Than 20 Years
[Marketwired] - Cellceutix Corporation (OTC: CTIX), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform....
read full: http://www.marketwired.com/press-release/bril...088217.htm
$CTIX filings - Perhaps the most important section
http://www.sec.gov/cgi-bin/browse-edgar?compa...getcompany
$CTIX charts
basic chart ## source: stockscores.com
$CTIX company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/CTIX/company-info
Ticker: $CTIX
OTC Market Place: OTC Pink Current
CIK code: 0001355250
Company name: Cellceutix Corp.
Company website: http://www.cellceutix.com
Incorporated In: NV, USA
Additional $CTIX company information:
## source: Opinion summary from various sources.
Business Description: Cellceutix is a publicly traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. This trial just completed its final cohort. Plans for a Ph 2/3 Ovarian Cancer Study are underway. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is currently conducting a Phase 2 clinical trial under Fast Track Designation with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol is presently in Phase 2 trial. Enrollment is complete. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s key antibiotic, Brilacidin, recently completed a successful Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Plans for a phase 3 trial are underway w/ FDA's approval. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. Please click on the below link to find for more information on completed and active Human Clinical Trials.
https://www.clinicaltrials.gov/ct2/results?te...rch=Search
$CTIX share structure
## source: otcmarkets.com
Market Value: $150,495,681 a/o Jan 22, 2016
Shares Outstanding: 118,500,536 a/o Oct 31, 2015
Float: Not Available
Authorized Shares: 300,000,000 a/o May 12, 2008
Par Value: 0.0001
$CTIX extra dd links
Company name: Cellceutix Corp.
Company website: http://www.cellceutix.com
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=CTIX+Historical+Prices
Company Profile (yahoo.com): http://www.finance.yahoo.com/q/pr?s=CTIX+Profile
Industry (yahoo.com): http://www.finance.yahoo.com/q/in?s=CTIX+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/CTIX/news - http://finance.yahoo.com/q/h?s=CTIX+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/CTIX/?wa=0
Basic Tech. Analysis (yahoo.com): http://www.finance.yahoo.com/q/ta?s=CTIX+Basi....+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/CTIX
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&am...eutix+Corp.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results...=0&y=0
WHOIS (domaintools.com): http://www.whois.domaintools.com/http://www.cellceutix.com
Alexa (alexa.com): http://www.alexa.com/siteinfo/http://www.cellceutix.com#
## FUNDAMENTALS ##
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/compa...yword/CTIX
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/financials?...-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?actio...p;count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/CTIX/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/CTIX/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/dividend-history
OTC Short Report (otcshortreport.com): http://www.otcshortreport.com/index.php?index=CTIX
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/CTIX/short-sales
Key Statistics (yahoo.com): http://www.finance.yahoo.com/q/ks?s=CTIX+Key+Statistics
Insider Roster (yahoo.com): http://www.finance.yahoo.com/q/ir?s=CTIX+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=CTIX
Balance Sheet (yahoo.com): http://www.finance.yahoo.com/q/bs?s=CTIX
Cash Flow (yahoo.com): http://www.finance.yahoo.com/q/cf?s=CTIX+Cash...amp;annual
## HOLDINGS ##
Major holdings (cnbc.com): http://www.data.cnbc.com/quotes/CTIX/tab/8.1
Insider transactions (yahoo.com): http://www.finance.yahoo.com/q/it?s=CTIX+Insi...ansactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/CTIX.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=CTIX
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/CTIX/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/CTIX
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/CTIX:US
Morningstar (morningstar.com): http://www.quotes.morningstar.com/stock/s?t=CTIX
Bussinessweek (businessweek.com): http://www.investing.businessweek.com/researc...icker=CTIX
********************************************************
**The below section courtesy of Slcimmuno**
1) PIPELINE MILESTONES/CATALYSTS
Oncology
- Completion of K Phase 1 (Solid Tumor) -- article has been submitted to a peer review journal for publication
- Initiation of several other K Phase 2, 2/3 trials -- ovarian, pediatric retinoblastoma, 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 (eg, 2-3x week); company pursuing outside grant support; addtl Orphan designations possible beyond the two already awarded for ovarian, pediatric retinoblastoma; more expedited pathway designations possible, e.g., Breakthrough Therapy
See:
http://www.fda.gov/downloads/AboutFDA/Centers...447162.pdf
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, per QIDP
See:
https://en.wikipedia.org/wiki/Brilacidin
See:
http://www.researchgate.net/profile/Chandradh...8a1ca5.pdf
- Phase 2 B-OM (oral mucositis) -- FDA has granted Fast Track status; 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
Dermatology
- Phase 2 Prurisol update -- enrollment is complete (plaque psoriasis)
2) OPERATIONS
- Financing in place (shelf, Aspire)
- 1st Shareholder meeting (Dec 15)
- NASDAQ uplisting
- Class Action Defense (Legal/Sullivan)
- Partners: more a question of when not if as science continues to prove out -- could happen anytime. One case study, see CELG-Nurix deal (p53)
https://blogs.shu.edu/cancer/2015/09/30/ubiqu...d-celgene/
3) CURRENT TRIALS
https://www.clinicaltrials.gov/ct2/results?te...rch=Search
1. P (Phase 2, Active, not recruiting): https://www.clinicaltrials.gov/ct2/show/NCT02...amp;rank=2
2. B-OM (Phase 2, recruiting): https://www.clinicaltrials.gov/ct2/show/NCT02...amp;rank=3
3. K (Phase 1, Active, not recruiting): https://www.clinicaltrials.gov/ct2/show/NCT01...amp;rank=4
4. B-ABSSSI (Phase 2, completed): https://www.clinicaltrials.gov/ct2/show/NCT02...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:
http://www.cellceutix.com
$CTIX recent news
PR's from Cellceutix:
http://www.cellceutix.com/category/press-rele...r967e.dpbs
PR's from Yahoo/Marketwired:
Mon, 25 Jan 2016 ~ Cellceutix Phase 2 Trial of New Oral Treatment for Psoriasis Nearing Completion
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...
read full: http://www.finance.yahoo.com/news/cellceutix-...00315.html
Fri, 22 Jan 2016 ~ Cellceutix Releases Data Used in Receiving FDA Orphan Drug Designation of Kevetrin for Pancreatic Cancer
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today released information ...
read full: http://www.finance.yahoo.com/news/cellceutix-...42403.html
Thu, 21 Jan 2016 ~ Cellceutix Receives FDA Orphan Drug Designation for Kevetrin for the Treatment of Pancreatic Cancer
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...
read full: http://www.finance.yahoo.com/news/cellceutix-...58464.html
January 19, 2016 ~ Cellceutix Submits Briefing Book for Phase 2 Trial of p53 Targeting Drug for Ovarian Cancer
[Marketwired] - Cellceutix Corporation (OTC: CTIX), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform......
read full: http://www.marketwired.com/press-release/cell...089125.htm
January 14, 2016 ~ Brilacidin Lyophilized as Cellceutix Prepares to Bring First New Class of Antibiotic to Phase 3 Trials in More Than 20 Years
[Marketwired] - Cellceutix Corporation (OTC: CTIX), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform....
read full: http://www.marketwired.com/press-release/bril...088217.htm
$CTIX filings - Perhaps the most important section
http://www.sec.gov/cgi-bin/browse-edgar?compa...getcompany
$CTIX charts
basic chart ## source: stockscores.com
$CTIX company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/CTIX/company-info
Ticker: $CTIX
OTC Market Place: OTC Pink Current
CIK code: 0001355250
Company name: Cellceutix Corp.
Company website: http://www.cellceutix.com
Incorporated In: NV, USA
Additional $CTIX company information:
## source: Opinion summary from various sources.
Business Description: Cellceutix is a publicly traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. This trial just completed its final cohort. Plans for a Ph 2/3 Ovarian Cancer Study are underway. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is currently conducting a Phase 2 clinical trial under Fast Track Designation with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol is presently in Phase 2 trial. Enrollment is complete. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s key antibiotic, Brilacidin, recently completed a successful Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Plans for a phase 3 trial are underway w/ FDA's approval. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. Please click on the below link to find for more information on completed and active Human Clinical Trials.
https://www.clinicaltrials.gov/ct2/results?te...rch=Search
$CTIX share structure
## source: otcmarkets.com
Market Value: $150,495,681 a/o Jan 22, 2016
Shares Outstanding: 118,500,536 a/o Oct 31, 2015
Float: Not Available
Authorized Shares: 300,000,000 a/o May 12, 2008
Par Value: 0.0001
$CTIX extra dd links
Company name: Cellceutix Corp.
Company website: http://www.cellceutix.com
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=CTIX+Historical+Prices
Company Profile (yahoo.com): http://www.finance.yahoo.com/q/pr?s=CTIX+Profile
Industry (yahoo.com): http://www.finance.yahoo.com/q/in?s=CTIX+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/CTIX/news - http://finance.yahoo.com/q/h?s=CTIX+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/CTIX/?wa=0
Basic Tech. Analysis (yahoo.com): http://www.finance.yahoo.com/q/ta?s=CTIX+Basi....+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/CTIX
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&am...eutix+Corp.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results...=0&y=0
WHOIS (domaintools.com): http://www.whois.domaintools.com/http://www.cellceutix.com
Alexa (alexa.com): http://www.alexa.com/siteinfo/http://www.cellceutix.com#
## FUNDAMENTALS ##
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/compa...yword/CTIX
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/financials?...-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?actio...p;count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/CTIX/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/CTIX/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/dividend-history
OTC Short Report (otcshortreport.com): http://www.otcshortreport.com/index.php?index=CTIX
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/CTIX/short-sales
Key Statistics (yahoo.com): http://www.finance.yahoo.com/q/ks?s=CTIX+Key+Statistics
Insider Roster (yahoo.com): http://www.finance.yahoo.com/q/ir?s=CTIX+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=CTIX
Balance Sheet (yahoo.com): http://www.finance.yahoo.com/q/bs?s=CTIX
Cash Flow (yahoo.com): http://www.finance.yahoo.com/q/cf?s=CTIX+Cash...amp;annual
## HOLDINGS ##
Major holdings (cnbc.com): http://www.data.cnbc.com/quotes/CTIX/tab/8.1
Insider transactions (yahoo.com): http://www.finance.yahoo.com/q/it?s=CTIX+Insi...ansactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/CTIX.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=CTIX
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/CTIX/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/CTIX/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/CTIX
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/CTIX:US
Morningstar (morningstar.com): http://www.quotes.morningstar.com/stock/s?t=CTIX
Bussinessweek (businessweek.com): http://www.investing.businessweek.com/researc...icker=CTIX
********************************************************
**The below section courtesy of Slcimmuno**
1) PIPELINE MILESTONES/CATALYSTS
Oncology
- Completion of K Phase 1 (Solid Tumor) -- article has been submitted to a peer review journal for publication
- Initiation of several other K Phase 2, 2/3 trials -- ovarian, pediatric retinoblastoma, 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 (eg, 2-3x week); company pursuing outside grant support; addtl Orphan designations possible beyond the two already awarded for ovarian, pediatric retinoblastoma; more expedited pathway designations possible, e.g., Breakthrough Therapy
See:
http://www.fda.gov/downloads/AboutFDA/Centers...447162.pdf
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, per QIDP
See:
https://en.wikipedia.org/wiki/Brilacidin
See:
http://www.researchgate.net/profile/Chandradh...8a1ca5.pdf
- Phase 2 B-OM (oral mucositis) -- FDA has granted Fast Track status; 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
Dermatology
- Phase 2 Prurisol update -- enrollment is complete (plaque psoriasis)
2) OPERATIONS
- Financing in place (shelf, Aspire)
- 1st Shareholder meeting (Dec 15)
- NASDAQ uplisting
- Class Action Defense (Legal/Sullivan)
- Partners: more a question of when not if as science continues to prove out -- could happen anytime. One case study, see CELG-Nurix deal (p53)
https://blogs.shu.edu/cancer/2015/09/30/ubiqu...d-celgene/
3) CURRENT TRIALS
https://www.clinicaltrials.gov/ct2/results?te...rch=Search
1. P (Phase 2, Active, not recruiting): https://www.clinicaltrials.gov/ct2/show/NCT02...amp;rank=2
2. B-OM (Phase 2, recruiting): https://www.clinicaltrials.gov/ct2/show/NCT02...amp;rank=3
3. K (Phase 1, Active, not recruiting): https://www.clinicaltrials.gov/ct2/show/NCT01...amp;rank=4
4. B-ABSSSI (Phase 2, completed): https://www.clinicaltrials.gov/ct2/show/NCT02...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:
http://www.cellceutix.com
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