Last $3.38 USD
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Volume 802.2K
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As of 8:10 PM 10/24/14 All times are local (Market data is delayed by at least 15 minutes).

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cellceutix corp (CTIX) Details

Cellceutix Corporation, a clinical stage biopharmaceutical company, focuses on discovering and developing small molecule drugs to treat drug-resistant cancers, psoriasis, autism, and inflammatory diseases. Its flagship compounds include Kevetrin, an anti-cancer compound that is in Phase I clinical trial for the treatment of cancer; Prurisol, an anti-psoriasis drug candidate that has completed Phase I clinical trial; and Brilacidin, an antibiotic candidate for the treatment of diabetic foot ulcer infections, and other indications, such as ophthalmic and otitic infections, as well as for other skin infections and oral mucositis. The company’s preclinical stage compounds comprise KM 391 for the treatment of autism; KM 277 for the treatment of rheumatoid arthritis; KM 278 for the treatment of arthritis/asthma; KM 362 for the treatment of MS/ALS/Parkinson’s disease; KM-3174 for the treatment of cancer; and KM-732 for hypertensive emergency, as well as Delparantag, a synthetic small-molecule for the treatment of other diseases, including chronic obstructive pulmonary disease. In addition, its other product candidates include compounds active against other gram-negative bacterias, malaria, tuberculosis, biowarfare pathogens, and PolyCide antimicrobial biomaterials. The company was founded in 2007 and is headquartered in Beverly, Massachusetts.

9 Employees
Last Reported Date: 09/15/14
Founded in 2007

cellceutix corp (CTIX) Top Compensated Officers

Chairman, Chief Executive & Financial Officer...
Total Annual Compensation: $444.7K
President, Chief Scientific Officer and Direc...
Total Annual Compensation: $444.7K
Compensation as of Fiscal Year 2014.

cellceutix corp (CTIX) Key Developments

Cellceutix Corporation Announces Positive Top-Line Data from Phase 2B Absssi Trial

Cellceutix Corporation announced positive top-line results for its Phase 2b randomized double-blind study comparing three dosing regimens of Brilacidin to daptomycin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The trial, which began in February, enrolled 215 subjects, with approximately 25% in each treatment arm. The primary endpoint was clinical success in the intent-to-treat population, defined as reduction of at least 20% in area of ABSSSI lesion, relative to baseline, when observed 48-72 hours after the first dose of study drug, and no rescue antibiotics administered. This is consistent with the 2013 Food and Drug Administration (FDA) guidance for ABSSSI studies and is the same endpoint used in recent approvals for ABSSSI drugs. All three Brilacidin treatment arms (two single-dose regimens and one three-day dose regimen) reached the primary endpoint, with the clinical success rate for each dosing regimen statistically comparable to the clinical success rate of the FDA-approved seven-day dosing regimen of daptomycin. All Brilacidin treatment regimens were well tolerated. There were six severe adverse events (SAE) reported across the study, none of which were considered related to Brilacidin by the principal investigator. Based upon the data, Cellceutix has decided that a pivotal Phase 3 trial in 2015 will be for a single-dose of Brilacidin for ABSSSI. Brilacidin is the first in a novel class of antibiotics known as defensin-mimetics being developed by Cellceutix. The platform is being used to develop other anti-infective drugs to address areas of high medical need, such as antibiotics for the treatment of resistant Gram-negative infections and fungal infections.

Cellceutix Corporation Announces Investigational New Drug Application Becomes Effective, Selects First Site for Phase 2 Clinical Trial of New Treatment for Oral Mucositis

Cellceutix Corporation announced that its investigational new drug (IND) has become effective and that the University of Texas MD Anderson Cancer Center has been selected as a clinical site for Cellceutix's Phase 2 trial of Brilacidin-OM as a novel treatment for oral mucositis. There are currently no drugs approved by the U.S. Food and Drug Administration (FDA) for treating the approximately 500,000 people each year who have oral mucositis from head and neck cancers, a common and often debilitating condition affecting the mouth and pharynx as a side effect of certain cancer treatments, including chemotherapy and radiation therapy given. Cellceutix had submitted its Investigational New Drug application to the FDA in September. This is the fourth clinical trial program at Cellceutix. The three other programs are cancer (solid tumors), Acute Bacterial Skin and Skin Structure Infections (ABSSSI), and psoriasis. Regarding the ABSSSI trial, which compared short-course treatments of Brilacidin to FDA-approved treatments of daptomycin, Cellceutix is pleased to update shareholders that the data from all trial sites has been locked and top-line data is expected this month.

Cellceutix Corporation Announces Update on its Recently Completed Phase 2B Study of Brilacidin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Cellceutix Corporation announced this update on its recently completed Phase 2b study of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections ('ABSSSI'). The study was a 215-patient blinded trial with four treatment arms and approximately 50-55 patients per arm. Three of the arms evaluated Brilacidin, two single-dose arms and one 3-day regimen, and the fourth arm was daptomycin of once per day for seven days. Daptomycin for injection is marketed by Cubist Pharmaceuticals under the brand name Cubicin(R) and generated approximately $447 million in sales in the first half of 2014. The initial results from the study are general observations and only considered blinded data averaged across all four treatment groups. Similar to a previously conducted Phase 2a study, Staphylococcus aureus (including MRSA) was the most common bacteria isolated at the baseline visit. The data shows that by Day 7, the average cure rate for all four treatment arms was higher than what was observed in the phase 2a study, and similar to - if not higher than - cure rates reported for common ABSSSI drugs, as well as those approved this year. Because 3/4 of the patients in this study were treated with Brilacidin, this high average cure rate is heavily influenced by Brilacidin, and less influenced by daptomycin, which only 1/4 patients received. This also means that the two single-dose treatment arms are providing half of the data toward this positive average cure rate; and if these data hold up, a single-dose regimen of Brilacidin would be the Company's Phase 3 study design. Oral mucositis is a common and often debilitating inflammation and ulceration in the mouth as a side effect of certain cancer treatments, including chemotherapy and radiation therapy that affects nearly half a million people each year. Laboratory studies of Brilacidin-OM have demonstrated antibacterial, anti-biofilm and anti-inflammatory properties of Brilacidin-OM as an oral rinse that significantly reduced the duration of oral mucositis by 90% or more. There are currently no FDA-approved preventative or therapeutic drugs to treat oral mucositis induced by a broad spectrum of cancer therapies.


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