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 ...
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 ...
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 ...
January 19, 2016 ~ Cellceutix Submits Briefing Book for Phase 2 Trial of p53 Targeting Drug for Ovarian Cancer
[Marketwired] - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform......
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) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform....
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.
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
- 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
- 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
- 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
- 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)
Cellceutix is progressing very nicely. Brilacidin also continues to be the hot topic and I'm thinking we're very close to seeing that get underway.
The Phase 3 ABSSSI program would include two Phase 3 ABSSSI studies, as required by FDA Guidance (October 2013), of approximately 700 subjects in each study. The two studies may enroll subjects simultaneously. In addition, the first study would include an interim analysis after a portion of the patients has been enrolled. This would provide an early assessment of both safety and efficacy.
The Company is now engaged in activities necessary for beginning the Phase 3 study. Manufacturing of Brilacidin has been completed and is presently undergoing quality control and stability testing
Brilacidin -- Ulcerative Proctitis / Colitis and Hidradenitis Suppurativa
We have also identified inflammatory gastrointestinal disease (ulcerative proctitis) and inflammatory skin disease (hidradenitis suppurativa) as indications for treatment with Brilacidin or our other HDP mimics. The Company plans for a Phase 2 proof of concept trial for ulcerative proctitis to begin in March 2016.
Big K talking about the refrigeration/freeze/ "room temperature" formulation. Imagine the durability that will have world wide.
Brilacidin for Topical Applications and Otic Infections and Related Formulation Work
Cellceutix is formulating and conducting preclinical experiments on topical Brilacidin for use in topical skin applications such as diabetic foot ulcer infections, and for ear-related infections, such as otitis externa or draining otitis media. On July 14, 2014, the Company announced that a significant breakthrough had been made in the formulation of Brilacidin. Previously, Brilacidin was stored in a refrigerated state. The Company has now developed the formulation of Brilacidin to be stable at room temperature. However, further formulation work is still needed for each indication. Upon developing optimal formulations, the Company plans to advance these drugs into the clinic. The Company believes this work, though challenging, is very important.
This will be a very quick revenue generator imo. Each indication is important. Someone googles an indication and whala, leads them to brilacidin for the treatment. Very cool.
Funding isn't an immediate issue, consider the grant and sponsorship potential. Kevetrin has very good support already for 2 indications (in the form of FDA support and possible grant support). Of course there is Aspire and the shelf reg as well. Prurisol is in motion. Data pending for kevetrin. I'm thinking there's plenty to be excited about as far as a start up bio with solid integrity moving forward.
Either way Hound, keep up the GREAT work you're doing keeping all the info together for the board!!
Go CTIX!!
And at this level? I see some mention of a weakening sector possibly adding to the bearishness of Cellceutix. Quite the opposite imo. More opportunity as many other WEAKER companies are now at an even keel PPS wise that we now have an even better chance for visibility. Competition should be on notice.
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.
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
- 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
- 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
- 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
- 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)
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