3-31-16 $CTIX ~ Cellceutix Corp. Due Diligence Rep
Post# of 72440
Posted On: 03/31/2016 11:00:12 AM
3-31-16 $CTIX ~ Cellceutix Corp. Due Diligence Report
$CTIX news
http://www.cellceutix.com/category/press-rele...r967e.dpbs
Latest PR's from Cellceutix:
Thur, 31 Mar 2016 ~ Cellceutix Successfully Completes In Vitro Study in Support of Planned Phase 2 Trial of Kevetrin for Ovarian Cancer
read more: http://www.marketwired.com/press-release/cell...110659.htm
Wed, 30 Mar 2016 ~ Cellceutix Receives Preliminary Approval for Clinical Trial of Brilacidin for Ulcerative Proctitis
read more: http://cellceutix.com/cellceutix-receives-pre...ott2H.dpbs
Thur, 17 Mar 2016 ~ Cellceutix Concludes Last Patient Visit in Phase 2 FDA Trial of Oral Dosed Prurisol in Patients With Mild-to-Moderate Chronic Plaque Psoriasis
read more: http://cellceutix.com/cellceutix-concludes-la...cJyzj.dpbs
Tue, 8 Mar 2016 ~ Cellceutix Corporation Welcomes Dr. Stephen T. Sonis to Its Scientific Advisory Board
read more: http://cellceutix.com/cellceutix-corporation-...Z3WZS.dpbs
Tue, 1 Mar 2016 ~ Cellceutix Completes Dosing in Phase 2 Trial of Prurisol for Chronic Psoriasis, Top-Line Data Anticipated in May
read more: http://cellceutix.com/cellceutix-completes-do...hDdHN.dpbs
Fri, 26 Feb 2016 ~ Cellceutix Submits Special Protocol Assessment Request to FDA for Phase 3 Clinical Trial of Brilacidin for ABSSSI
read more: http://cellceutix.com/cellceutix-submits-spec...v1FSM.dpbs
$CTIX filings - Perhaps the most important section
http://www.sec.gov/cgi-bin/browse-edgar?compa...getcompany
$CTIX charts
$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: Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. 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 concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its FDA application for a Phase 2 ovarian cancer study. 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 in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain 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. More information is available on the Cellceutix web site at www.cellceutix.com.
To find more information on completed and active Human Clinical Trials, please click the below link.
https://www.clinicaltrials.gov/ct2/results?te...rch=Search
$CTIX Share Structure
## source: otcmarkets.com
Market Value: $132,602,100 a/o Feb 09, 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
Various $CTIX DD links
Cellceutix Corp. website - http://www.cellceutix.com
Company Email - info@cellceutix.com
Management - http://cellceutix.com/team/
Product Pipeline - http://cellceutix.com/pipeline/
Recent News and Press Releases - http://finance.yahoo.com/q/h?s=CTIX+Headlines
SEC Filings - http://www.sec.gov/cgi-bin/browse-edgar?compa...getcompany
Financials - http://www.otcmarkets.com/stock/CTIX/financials
Transfer Agent - http://www.westcoaststocktransfer.com/
Short Interest - http://www.otcmarkets.com/stock/CTIX/short-sales
Key Statistics - http://www.finance.yahoo.com/q/ks?s=CTIX+Key+Statistics
Insider Roster - http://www.finance.yahoo.com/q/ir?s=CTIX+Insider+Roster
Insider transactions - http://www.secform4.com/insider-trading/CTIX.htm
Income Statement - http://finance.yahoo.com/q/is?s=CTIX
Balance Sheet - http://www.finance.yahoo.com/q/bs?s=CTIX
Cash Flow - http://www.finance.yahoo.com/q/cf?s=CTIX+Cash...amp;annual
Cellceutix IP - Patent Filings:
EPO
http://worldwide.espacenet.com/searchResults?...pact=false
WIPO
http://www.wipo.int/patentscope/search/en/det...ing=FP src="/images/icons/icon_sad.gif" class="post_smiley" /> Cellceutix)&maxRec=1
USPTO
http://appft.uspto.gov/netacgi/nph-Parser?Sec...amp;d=PG01
http://patft.uspto.gov/netacgi/nph-Parser?Sec.../8,796,275
********************************************************
**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 -- Trial is complete (plaque psoriasis). Top-line data is expected to be available in the coming weeks.
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
http://www.clinicaltrials.gov/ct2/results?ter...rch=Search
1. P (Phase 1, Successful Completion): http://clinicaltrials.gov/ct2/show/NCT0210121...amp;rank=1
P (Phase 2, Trial Complete - Awaiting Results): http://www.clinicaltrials.gov/ct2/show/NCT024...amp;rank=2
2. B-OM (Phase 2, Active, Recruiting): http://www.clinicaltrials.gov/ct2/show/NCT023...amp;rank=3
3. K (Phase 1, Successful Completion): http://www.clinicaltrials.gov/ct2/show/NCT016...amp;rank=4
4. B-ABSSSI (Phase 2, Successful Completion): http://www.clinicaltrials.gov/ct2/show/NCT020...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 news
http://www.cellceutix.com/category/press-rele...r967e.dpbs
Latest PR's from Cellceutix:
Thur, 31 Mar 2016 ~ Cellceutix Successfully Completes In Vitro Study in Support of Planned Phase 2 Trial of Kevetrin for Ovarian Cancer
read more: http://www.marketwired.com/press-release/cell...110659.htm
Wed, 30 Mar 2016 ~ Cellceutix Receives Preliminary Approval for Clinical Trial of Brilacidin for Ulcerative Proctitis
read more: http://cellceutix.com/cellceutix-receives-pre...ott2H.dpbs
Thur, 17 Mar 2016 ~ Cellceutix Concludes Last Patient Visit in Phase 2 FDA Trial of Oral Dosed Prurisol in Patients With Mild-to-Moderate Chronic Plaque Psoriasis
read more: http://cellceutix.com/cellceutix-concludes-la...cJyzj.dpbs
Tue, 8 Mar 2016 ~ Cellceutix Corporation Welcomes Dr. Stephen T. Sonis to Its Scientific Advisory Board
read more: http://cellceutix.com/cellceutix-corporation-...Z3WZS.dpbs
Tue, 1 Mar 2016 ~ Cellceutix Completes Dosing in Phase 2 Trial of Prurisol for Chronic Psoriasis, Top-Line Data Anticipated in May
read more: http://cellceutix.com/cellceutix-completes-do...hDdHN.dpbs
Fri, 26 Feb 2016 ~ Cellceutix Submits Special Protocol Assessment Request to FDA for Phase 3 Clinical Trial of Brilacidin for ABSSSI
read more: http://cellceutix.com/cellceutix-submits-spec...v1FSM.dpbs
$CTIX filings - Perhaps the most important section
http://www.sec.gov/cgi-bin/browse-edgar?compa...getcompany
$CTIX charts
$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: Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. 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 concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its FDA application for a Phase 2 ovarian cancer study. 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 in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain 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. More information is available on the Cellceutix web site at www.cellceutix.com.
To find more information on completed and active Human Clinical Trials, please click the below link.
https://www.clinicaltrials.gov/ct2/results?te...rch=Search
$CTIX Share Structure
## source: otcmarkets.com
Market Value: $132,602,100 a/o Feb 09, 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
Various $CTIX DD links
Cellceutix Corp. website - http://www.cellceutix.com
Company Email - info@cellceutix.com
Management - http://cellceutix.com/team/
Product Pipeline - http://cellceutix.com/pipeline/
Recent News and Press Releases - http://finance.yahoo.com/q/h?s=CTIX+Headlines
SEC Filings - http://www.sec.gov/cgi-bin/browse-edgar?compa...getcompany
Financials - http://www.otcmarkets.com/stock/CTIX/financials
Transfer Agent - http://www.westcoaststocktransfer.com/
Short Interest - http://www.otcmarkets.com/stock/CTIX/short-sales
Key Statistics - http://www.finance.yahoo.com/q/ks?s=CTIX+Key+Statistics
Insider Roster - http://www.finance.yahoo.com/q/ir?s=CTIX+Insider+Roster
Insider transactions - http://www.secform4.com/insider-trading/CTIX.htm
Income Statement - http://finance.yahoo.com/q/is?s=CTIX
Balance Sheet - http://www.finance.yahoo.com/q/bs?s=CTIX
Cash Flow - http://www.finance.yahoo.com/q/cf?s=CTIX+Cash...amp;annual
Cellceutix IP - Patent Filings:
EPO
http://worldwide.espacenet.com/searchResults?...pact=false
WIPO
http://www.wipo.int/patentscope/search/en/det...ing=FP
USPTO
http://appft.uspto.gov/netacgi/nph-Parser?Sec...amp;d=PG01
http://patft.uspto.gov/netacgi/nph-Parser?Sec.../8,796,275
********************************************************
**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 -- Trial is complete (plaque psoriasis). Top-line data is expected to be available in the coming weeks.
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
http://www.clinicaltrials.gov/ct2/results?ter...rch=Search
1. P (Phase 1, Successful Completion): http://clinicaltrials.gov/ct2/show/NCT0210121...amp;rank=1
P (Phase 2, Trial Complete - Awaiting Results): http://www.clinicaltrials.gov/ct2/show/NCT024...amp;rank=2
2. B-OM (Phase 2, Active, Recruiting): http://www.clinicaltrials.gov/ct2/show/NCT023...amp;rank=3
3. K (Phase 1, Successful Completion): http://www.clinicaltrials.gov/ct2/show/NCT016...amp;rank=4
4. B-ABSSSI (Phase 2, Successful Completion): http://www.clinicaltrials.gov/ct2/show/NCT020...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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