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GuruFocus Financial Strength Rank measures how strong a company’s financial situation is. It is based on these factors

1. The debt burden that the company has as measured by its Interest coverage (current year).
2. Debt to revenue ratio. The lower, the better
3. Altman Z-score.

A company ranks high with financial strength is likely to withstand any business slowdowns and recessions.

Financial Strength : 4/10

vs
industry
vs
history
Cash-to-Debt 2.78
CTIX's Cash-to-Debt is ranked lower than
72% of the 943 Companies
in the Global Biotechnology industry.

( Industry Median: 54.02 vs. CTIX: 2.78 )
Ranked among companies with meaningful Cash-to-Debt only.
CTIX' s Cash-to-Debt Range Over the Past 10 Years
Min: 0.01  Med: 3.06 Max: No Debt
Current: 2.78
Piotroski F-Score: 2
Altman Z-Score: -5.05
GuruFocus Profitability Rank ranks how profitable a company is and how likely the company’s business will stay that way. It is based on these factors:

1. Operating Margin
2. Trend of the Operating Margin (5-year average). The company with an uptrend profit margin has a higher rank.
••3. Consistency of the profitability
4. Piotroski F-Score
5. Predictability Rank•

The maximum rank is 10. A rank of 7 or higher means a higher profitability and may stay that way. A rank of 3 or lower indicates that the company has had trouble to make a profit.

Profitability Rank is not directly related to the Financial Strength Rank. But if a company is consistently profitable, its financial strength will be stronger.

Profitability & Growth : 3/10

vs
industry
vs
history
ROE % -729.15
CTIX's ROE % is ranked lower than
97% of the 853 Companies
in the Global Biotechnology industry.

( Industry Median: -36.35 vs. CTIX: -729.15 )
Ranked among companies with meaningful ROE % only.
CTIX' s ROE % Range Over the Past 10 Years
Min: -729.15  Med: -257.35 Max: -235
Current: -729.15
-729.15
-235
ROA % -127.80
CTIX's ROA % is ranked lower than
88% of the 950 Companies
in the Global Biotechnology industry.

( Industry Median: -29.87 vs. CTIX: -127.80 )
Ranked among companies with meaningful ROA % only.
CTIX' s ROA % Range Over the Past 10 Years
Min: -2870.38  Med: -215.36 Max: -99.77
Current: -127.8
-2870.38
-99.77
ROC (Joel Greenblatt) % -12366.42
CTIX's ROC (Joel Greenblatt) % is ranked lower than
90% of the 907 Companies
in the Global Biotechnology industry.

( Industry Median: -394.49 vs. CTIX: -12366.42 )
Ranked among companies with meaningful ROC (Joel Greenblatt) % only.
CTIX' s ROC (Joel Greenblatt) % Range Over the Past 10 Years
Min: -41215.38  Med: -33618.18 Max: -12366.42
Current: -12366.42
-41215.38
-12366.42
3-Year EBITDA Growth Rate 46.30
CTIX's 3-Year EBITDA Growth Rate is ranked higher than
88% of the 534 Companies
in the Global Biotechnology industry.

( Industry Median: -0.90 vs. CTIX: 46.30 )
Ranked among companies with meaningful 3-Year EBITDA Growth Rate only.
CTIX' s 3-Year EBITDA Growth Rate Range Over the Past 10 Years
Min: -5.7  Med: 46.75 Max: 94.9
Current: 46.3
-5.7
94.9
3-Year EPS without NRI Growth Rate 40.10
CTIX's 3-Year EPS without NRI Growth Rate is ranked higher than
86% of the 519 Companies
in the Global Biotechnology industry.

( Industry Median: -2.90 vs. CTIX: 40.10 )
Ranked among companies with meaningful 3-Year EPS without NRI Growth Rate only.
CTIX' s 3-Year EPS without NRI Growth Rate Range Over the Past 10 Years
Min: 0  Med: 42.15 Max: 100
Current: 40.1
0
100
GuruFocus has detected 1 Warning Sign with Cellceutix Corp $CTIX.
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Business Description

Industry: Biotechnology » Biotechnology    NAICS: 325414    SIC: 2834
Compare:AMEX:XXII, NYSE:KDMN, NAS:CDXC, OTCPK:BNOEF, OTCPK:VNLPY, OTCPK:INNMF, NAS:SBPH, OTCPK:HPPI, NAS:CBAY, OTCPK:IMMVF, NAS:SRNE, NAS:VTL, NAS:EVGN, NAS:VVUS, NAS:BDSI, NAS:PRQR, NAS:PSTI, NAS:DRNA, NAS:FATE, NAS:ADVM » details
Headquarter Location:USA
Cellceutix Corp is a biopharmaceutical company. The Company is engaged in the business of developing small molecule therapies to treat diseases in the areas of cancer, dermatology, infections, and inflammatory disease.

Cellceutix Corp was incorporated as Econoshare, Inc. on August 1, 2005, in the State of Nevada. On December 6, 2007, the Company acquired Cellceutix Pharma, Inc., a privately owned corporation formed under the laws of the State of Delaware on June 20, 2007. It is a clinical stage biopharmaceutical company developing therapies with oncology, dermatology and antimicrobial applications. It owns the rights to numerous drug compounds, including Kevetrin (thioureidobutyronitrile), an anti-cancer compound; Prurisol (KM-133), which is in development for psoriasis; and Brilacidin. The Company's operations and activities are subject to extensive regulation by numerous government authorities in the United States and other countries.

Top Ranked Articles about Cellceutix Corp

Cellceutix Provides Corporate Update; Significant Milestones Ahead as Multiple Mid-Phase Clinical Trials Set to Conclude
Cellceutix Announces Details for Upcoming Investor and Shareholder Presentations
Cellceutix CEO Discusses Brilacidin Following Interim Trial Results for Treating Oral Mucositis and Inflammatory Bowel Disease
Cellceutix AACR Poster Presents Data Supporting Kevetrin Modulation of p53 in Multiple Human Ovarian Cancer Cell-lines and Corresponding Xenograft Tumors
Cellceutix Reports Very Encouraging Interim Analysis of Phase 2 Drug Candidate Brilacidin for Severe Oral Mucositis (OM) in Head and Neck Cancer Patients; High Potential for Preventative Treatment

Study showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent)

BEVERLY, Mass., March 27, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (CTIX) (“the Company”), today presented positive results from the Company's ongoing randomized, double-blind Phase 2 study of Brilacidin in the prevention and control of Oral Mucositis (OM) in patients receiving chemoradiation for treatment of Head and Neck Cancer. In a preliminary interim analysis, a marked reduction in incidence of Severe OM (WHO Grade > 3) was observed in patients treated with Brilacidin who received at least 55 Gy cumulative units of radiation. Study results, complementing favorable data released last week in the treatment of Ulcerative Proctitis/Proctosigmoiditis with Brilacidin, further establish Brilacidin as a novel anti-inflammatory drug candidate with potentially broad applications.
Presented below is information on Cellceutix’s clinical trial of Brilacidin for OM, including preliminary Interim Analysis of 19 patients (9 administered Brilacidin; 10 administered placebo) who have reached or passed the planned visit at the end of 5 weeks on study, and received a cumulative radiation dose of at least 55 Gy. STUDY DESIGN CTIX-BRI-205 is a Phase 2 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Brilacidin as an oral rinse in preventing and controlling OM in patients receiving chemoradiation therapy for Head and Neck Cancer. The study is anticipated to enroll approximately 60 patients in the United States, 30 each to Brilacidin treatment or to placebo (water). Brilacidin (45 mg/15 ml oral rinse -- “swish and spit”) is administered 3 times daily across 7 weeks (49 days). Pharmacokinetics of Brilacidin are to be evaluated if there is measurable systemic exposure (from drug concentrations in plasma). The Brilacidin OM trial uses a World Health Organization (WHO) OM Grading Scale, a common measurement tool in assessing the presence and severity of OM, as defined below. WHO Scale for OM Grade 0 = NoneGrade 1 = Erythema and Mouth Pain Soreness; no Ulceration/Pseudomembrane formationGrade 2 = Ulceration/Pseudomembrane formation; solid dietGrade 3 = Ulceration/Pseudomembrane formation; liquid dietGrade 4 = Ulceration/Pseudomembrane formation; not able to tolerate a solid or liquid diet (except enough liquid for medication) Primary Endpoints of the Brilacidin OM trial are: Incidence of Severe OM (WHO Grade > 3) experienced during radiation therapy (across 7 weeks) by patients with Head and Neck Cancer receiving a cumulative radiation dose of at least 55 Gy in the course of their chemoradiation treatmentSafety and Tolerability of Brilacidin  A Secondary Endpoint included in the Interim Analysis is: Duration of Severe OM (WHO Grade > 3) Pharmacokinetics of Brilacidin is determined from: Brilacidin concentrations in plasma INTERIM ANALYSIS Preliminary efficacy and safety data from 19 patients who met the criteria for evaluation were reviewed. To be included, patients needed to have reached or passed the planned visit at the end of 5 weeks on study, and have received a cumulative radiation dose of at least 55 Gy. Patients receiving Brilacidin, as compared to patients on placebo, showed a markedly reduced rate of Severe OM (WHO Grade > 3). Additionally, Brilacidin was generally safe and well-tolerated. Primary Efficacy Results Incidence of Severe OM (WHO Grade > 3) Active Arm (Brilacidin): 2 of 9 patients (22.2 percent)Control Arm (Placebo): 7 of 10 patients (70 percent) Secondary Efficacy Results Duration of Severe OM (WHO Grade > 3) Active Arm (Brilacidin): Mean 10.5 days (Range 3 to 18 days; 2 patients)Control Arm (Placebo): Mean 14 days (Range 3 to 39 days; 7 patients) Safety and Tolerability Profile Brilacidin administered as an oral rinse was generally well-tolerated by patientsSafety findings were typical for patients with Head and Neck Cancer being treated with chemoradiation; no treatment group differences were apparent on vital signs and clinical laboratory safety testsSix patients (2 in Active Arm, 4 in Control Arm) experienced at least one adverse event categorized as serious. Nine Serious Adverse Events (SAEs) were reported for these 6 patients, and all were classified by the Investigator as Not Related to study drugIncidence of Treatment-Emergent Adverse Events (TEAEs) Majority of the TEAEs reported (Active Arm, 164 TEAEs; Control Arm, 143 TEAEs) were related to chemoradiation or the underlying study indicationNo TEAEs were classified as Likely Related or Definitely Related to study treatment Pharmacokinetics Plasma samples from 6 patients treated with Brilacidin were analyzed and all concentrations of Brilacidin were below the lower limit of quantification (i.e., < 10 ng/mL) “These interim results suggest the potential for an even greater effective therapeutic response as formulation and dosing is further optimized,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. “There currently is no existing preventative treatment available for OM patients in this population, with only limited therapies focusing on symptom relief. Already under Fast Track designation, should Brilacidin earn FDA approval for the treatment of Oral Mucositis, countless patients may no longer have to suffer from this horribly debilitating condition as a side effect of cancer treatment. The use of Brilacidin to prevent the onset of OM could even lead to an entirely new standard of care in this area as we strive to bring this drug to market.” Cellceutix, over the past months, has added additional clinical sites to this study. Completion of the clinical trial is expected before year-end. Alerts: Sign-up for Cellceutix email alerts is available at: www.cellceutix.com/email-alerts About Brilacidin Brilacidin is Cellceutix’s lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, Cellceutix is studying Brilacidin’s effect on oral mucositis (under Fast Track designation) and on ulcerative proctitis/proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: hidradenitis suppurativa and acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) -- qualifying it for Fast Track and possible Priority FDA Review and a potential extra 5 years of United States market exclusivity upon drug approval. Learn more here:
http://www.cellceutix.com/brilacidin-1/ About Oral Mucositis Oral Mucositis (OM) is a frequent, painful and debilitating complication of chemoradiation commonly manifesting in the treatment of head and neck tumors. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak or eat (requiring the insertion of a feeding tube) and more susceptible to bacterial infections, with severe cases leading to hospitalization, with increased treatment costs of up to $25,000. Affecting over 500,000 people in the United States, there currently are no approved medications for the prevention of OM in this population, with only limited palliative care options available. Worldwide, the potential market for OM is expected to exceed $1 billion in the next few years. For more information on the CTIX-BRI-205 Phase 2 study, please visit:
https://clinicaltrials.gov/ct2/show/NCT02324335 About Cellceutix 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 first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix’s psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix has commenced a Phase 2 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 lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, 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”). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first two cohorts of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).  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. Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACT

Cellceutix Corporation
Leo Ehrlich
[email protected]

Read more...
Cellceutix Releases Favorable Topline Findings as Part of Interim Analysis of Phase 2 Drug Candidate Brilacidin for the Treatment of Inflammatory Bowel Disease

Study results, through the first two cohorts of patients treated, support Brilacidin as a novel and promising anti-inflammatory drug candidate

BEVERLY, Mass., March 21, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to inform shareholders that the Company today announces additional favorable topline findings as part of interim analysis from its ongoing Phase 2a Proof-of-Concept (PoC) study of Brilacidin for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).
As discussed in a prior press release, a large unmet need exists in the marketplace for treating IBD patients with newer, non-biologic therapies, which the Company believes Brilacidin, with its unique mechanism of action, is showing the potential of becoming. Presented below is information on Cellceutix’s study of Brilacidin in UP/UPS, including detailed trial results observed through the first two cohorts (12 patients). Three of six patients in the third and final cohort have been enrolled this week and the Company anticipates the full study will be completed in 2Q2017. STUDY DESIGN CTIX-BRI-206 is a Phase 2a open-label, dose-escalation study, evaluating the efficacy, safety and pharmacokinetics (PK) of 3 dosing regimens of Brilacidin—50 mg (Cohort A), 100 mg (Cohort B) and 200 mg (Cohort C)—in patients with active mild-to-moderate UP/UPS. Brilacidin is given daily as a retention enema across 42 consecutive days (6 weeks) of treatment. Endoscopic evaluation (photos and videos) of rectum and mucosa up to 40 cm from the anal verge in patients is performed at Screening and at End of Treatment (Day 42). The Primary Efficacy Endpoint of the Brilacidin UP/UPS trial uses Modified Mayo Disease Activity Index (MMDAI) scoring, a common measurement tool in managing Ulcerative Colitis preferred by many IBD specialists, to determine Clinical Remission at Day 42, as defined by meeting all three contributing criteria: Stool Frequency (SF)—an improvement or no change from baselineRectal Bleeding (RB)—subscore = 0 (no blood seen)Endoscopy Findings (EF)—subscore ≤ 1 (mild disease; normal or inactive disease) Secondary Efficacy Endpoints include: change in MMDAI score, Full and Partial (defined below); and change in patient Quality of Life (as assessed by the Short Inflammatory Bowel Disease Questionnaire or SIBDQ): Full MMDAI = SF RB PGA (Physician Global Assessment) EF subscoresPartial MMDAI = SF RB PGA subscores INTERIM ANALYSIS After 6 weeks (42 days) of daily treatment with Brilacidin all 12 patients from the first two cohorts experienced a beneficial response as measured by MMDAI scoring parameters. Efficacy Results Primary Efficacy Endpoint of Clinical Remission (accounting for Stool Frequency, Rectal Bleeding and Endoscopy Findings subscores)—50 percent of patients in Cohort A (3 of 6) and 50 percent of patients in Cohort B (3 of 6) met this endpoint; all 6 of the remaining patients in Cohorts A and B met 2 of the 3 criteria (Partial Response). Full MMDAI (accounting for Stool Frequency, Rectal Bleeding, Physician’s Global Assessment and Endoscopy Findings subscores)—notable improvements observed in 10 of 11 patients (one patient declined endoscopy at end of treatment): 100 percent reduction in 2 patients in Cohort A and 2 patients in Cohort B50-75 percent reduction in 2 patients in Cohort A and 4 patients in Cohort B20 percent reduction in 1 patient in Cohort A Partial MMDAI (accounting for Stool Frequency, Rectal Bleeding and Physician’s Global Assessment subscores)—notable improvements observed in 11 of 12 patients: 100 percent reduction in 3 patients in Cohort A and 3 patients in Cohort B50-83 percent reduction in 2 patients in Cohort A and 3 patients in Cohort B0 percent reduction in 1 patient in Cohort A Patient Quality of Life (as assessed by the Short Inflammatory Bowel Disease Questionnaire, SIBDQ)—notable improvements in all 12 patients; 50 percent of patients in Cohort A (3 of 6) and 80 percent of patients in Cohort B (5 of 6) reported significant improvements of 15 points to more than 50 points higher on the 70-point SIBDQ scale. Other Clinically Meaningful Observations Endoscopy subscore of ≤ 1 met in 7 of 11 patients (1 patient declined final endoscopy).PGA subscore improved for 10 of 12 patients.Rectal Bleeding subscore improved for all 12 patients.Stool Frequency subscore demonstrated improvement by study end for all patients who were abnormal at study start. Safety Profile Brilacidin was generally well-tolerated with No Serious Adverse Events (SAEs).All 16 Adverse Events (AEs) experienced by a total of 6 patients were rated by Investigators as “Unlikely Related” or “Not Related” to treatment.Clinical Laboratory Review (CLR): No clinically significant trends, changes or abnormalities observed in blood chemistry, hematology and urinalysis.Vital Signs: No clinically significant changes seen. Pharmacokinetics (PK) Limited systemic exposure to Brilacidin as measured by plasma concentrations: Cohort A (50 mg): All patients had concentrations <100 ng/mLCohort B (100 mg): Average maximum concentration was 215 ng/mL In comparison, maximum drug concentrations in plasma previously seen in CTIX-BRI-204, a successfully completed Phase 2b Trial of Brilacidin by intravenous (IV) dosing at 0.6 mg/kg and 0.8 mg/kg for Acute Bacterial Skin and Skin Structure Infection (ABSSSI), were approximately 9,000 ng/mL and 12,000 ng/mL respectively. “Of particular note in the results observed so far in the Brilacidin UP/UPS trial are clear signs of mucosal healing in patients as determined by independent review of endoscopic images and videos by practicing gastroenterologists,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix.  â€œA changing IBD treatment paradigm, as well as a regulatory one, is placing an increased emphasis on establishing Clinical Remission based on objective criteria, such as validated endoscopic response, and not just relying on subjective scoring systems. That a majority of patients treated with Brilacidin at the end of 6 weeks showed mild disease or no disease at all based on MMDAI Endoscopy subscores reinforces Brilacidin’s therapeutic potential in treating IBD.” “To see such consistently strong results through the first two cohorts of UP/UPS patients treated with Brilacidin is highly promising,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “With planned newer formulations, foam and oral, we believe Brilacidin could one day be extended into treating a number of chronic IBD indications. The Company looks forward to continuing to share results with investors and the public across the coming months and will be presenting topline findings at the 2017 Drug Discovery and Therapy World Congress to be held July 10-13, 2017 in Boston.” Alerts: Sign-up for Cellceutix email alerts is available at: www.cellceutix.com/email-alerts About Brilacidin Brilacidin is Cellceutix’s lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, Cellceutix is studying Brilacidin’s effect on oral mucositis (under Fast Track designation) and on ulcerative proctitis/proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: hidradenitis suppurativa and acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and a potential extra 5 years of United States market exclusivity upon drug approval. Learn more here:
http://www.cellceutix.com/brilacidin-1/ About Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD), with Ulcerative Colitis (UC) and Crohn’s Disease (CD) the most common forms, are lifelong, chronic conditions characterized by inflammation of the gastrointestinal (GI) track with symptoms fluctuating between periods of exacerbation and remission. The peak age for UC onset is between 30 and 40 years and between 20 and 30 years for CD. Approximately 20 percent of patients with UC experience active “moderate” or “severe” disease and 50 percent are in remission. Seventy percent of those with active disease of any severity and 30 percent of those in remission will experience episodes in the following year. In CD, 55 percent of patients in remission will have a relapse across the next year, with 11 percent having chronically active disease. Approximately 1.7 million people in the U.S. have IBD, with the total number of cases increasing by 70,000 cases annually. IBD greatly affects a person’s quality of life, including increased emotional distress and a reduced ability to work. Total societal costs, in the U.S. alone, attributable to IBD are estimated to range between $14.6 and $31.6 billion. The considerable economic burden of IBD makes an accurate diagnosis, coupled with effective treatment at the onset of symptoms, a critical component of IBD care. About UP/UPS Ulcerative proctitis (UP), a limited type of ulcerative colitis (UC), is a mucosal inflammatory disease of unknown cause involving only the rectum. When it involves both the rectum and the distal colon, it is called Ulcerative Proctosigmoiditis (UPS). It is characterized by inflammation, redness, and ulcerations of the mucosa. The course of the disease is variable and ranges from complete resolution to easily maintained remission to chronic relapses or refractory disease. Diagnosis can occur at any point in life, with approximately 30-50 percent of patients developing more extensive UC. There is currently no cure. According to estimates provided by GlobalData, the worldwide UC market, which includes products for UP/UPS, is expected to increase at a compound annual growth rate of 4.7 percent, from $4.2 billion in 2012 to approximately $6.6 billion by 2022. About Cellceutix’s Proof-of-Concept (PoC) UP/UPS Trial Design This trial is being conducted in an overseas hospital/clinic setting with Brilacidin being administered with water in an enema. A foam formulation of Brilacidin for use in future studies is planned and would be expected to improve patient convenience and study results. The primary objective of Cellceutix’s Proof-of-Concept (PoC) trial is to assess the frequency of clinical remission (defined using Modified Mayo Disease Activity Index [MMDAI] scoring) with Brilacidin administered per rectum by enema in patients with active UP or UPS after 6 weeks of treatment. Secondary objectives include: evaluation of safety and tolerability of Brilacidin when administered per rectum; assessment of systemic exposure and/or pharmacokinetics of Brilacidin when administered per rectum; assessment of the efficacy of Brilacidin by change in MMDAI at Day 42/Week 6 and Partial MMDAI during treatment and by biomarker evaluation (from serum, feces, and rectum/sigmoid biopsy samples); evaluation of change in patient-reported quality of life (by the Short Inflammatory Bowel Disease Questionnaire); and estimation of statistical power for subsequent trial(s) in UP and UPS. The PoC trial includes 18 patients divided evenly into three cohorts. Cohort A receives 50 milligrams (mg) of Brilacidin once daily administered per rectum as a retention enema for 42 days. Dosing is increased to 100 mg and 200 mg once daily for 42 days for Cohort B and Cohort C, respectively. Endoscopic evaluation of the rectum and mucosa up to 40 cm from the anal verge is performed at screening and at the end of treatment/Day 42 (± 3 days). Per protocol, a Safety Committee reviews safety and retention data (clinical laboratory findings, vital signs, adverse events, retention times) after 21 days of therapy for all six patients in each cohort before proceeding with initiating enrollment into the subsequent cohort. About Cellceutix 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 first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix’s psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix has commenced a Phase 2 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 lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, 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”). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first two cohorts of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).  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. Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACT

Cellceutix Corporation
Leo Ehrlich
[email protected]

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Cellceutix’s Phase 2 Drug Candidate Brilacidin Emerging as a Potential Novel Non-Biologic Therapy in Treating Inflammatory Bowel Disease

Study to help guide Cellceutix in continued development of Brilacidin, including planned foam and oral formulations for hard-to-treat chronic conditions like Ulcerative Colitis and Crohn’s Disease

BEVERLY, Mass., March 16, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to inform shareholders that, next week, the Company will be providing additional detailed data from its ongoing Phase 2a Proof-of-Concept (PoC) study of Brilacidin for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).
While advances in IBD treatment—specifically, the approval of Tumor Necrosis Factor (TNF) inhibitors—now offer patients more effective therapeutic options, biologics have major drawbacks. In addition to their high costs and the risk of serious side-effects is the potential loss of therapeutic response. One-third of patients on biologics lose response over time, often needing to be switched to another TNF inhibitor, and another one-third of patients fail to respond to TNF inhibitors at all. Moreover, management of IBD is moving from alleviation of symptoms toward long-term control of Gastrointestinal (GI) inflammation (preventing disease progression and recurrence). Avoiding initial treatment failure, which can cost an average of $11,500 per patient, and achieving sustained clinical remission, increasingly is a realistic goal for managing patients with IBD. In short, there exists a large unmet need in treating IBD patients with newer, non-biologic therapies, which we believe Brilacidin, with its unique mechanism of action, is showing the potential of becoming. Following the information released on March 8, 2017, disclosing preliminary efficacy and safety data as part of interim analysis from the first two cohorts (12 patients) in the UP/UPS trial, Cellceutix has received numerous requests from various interested parties to provide added context on Brilacidin and its potential in IBD. In the upcoming data release, we plan to provide further scope and breakdown of study results across the first two cohorts, along with other insights based on results observed to date. This summer, Cellceutix plans to present both topline findings from the complete Brilacidin-UP/UPS trial as well as interim data from its ongoing Phase 2 trial of Brilacidin for Oral Mucositis at Drug Discovery and Therapy World Congress 2017 to be held July 10 – 13, 2017 in Boston. More details to come. “We have received excellent results, to date, in our Brilacidin IBD trial, both regarding objective scores and subjective assessments. The systemic absorption of Brilacidin has been minimal while still yielding compelling patient responses,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. “We’re getting exactly what we need from a proof-of-concept study—clear and strong signals both as to the safety and the efficacy of Brilacidin in treating IBD. These results will help guide the continued development of Brilacidin, including planned foam and oral formulations, for hard-to-treat chronic conditions like Ulcerative Colitis and Crohn’s Disease.” Alerts: Sign-up for Cellceutix email alerts is available at: www.cellceutix.com/email-alerts About Brilacidin Brilacidin is Cellceutix’s lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, Cellceutix is studying Brilacidin’s effect on oral mucositis (under Fast Track designation) and on ulcerative proctitis/proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: hidradenitis suppurativa and acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and a potential extra 5 years of United States market exclusivity upon drug approval. Learn more here:
http://www.cellceutix.com/brilacidin-1/ About Inflammatory Bowel Disease Inflammatory Bowel Disease (IBD), with Ulcerative Colitis (UC) and Crohn’s Disease (CD) the most common forms, are lifelong, chronic conditions characterized by inflammation of the gastrointestinal (GI) track with symptoms fluctuating between periods of exacerbation and remission. The peak age for UC onset is between 30 and 40 years and between 20 and 30 years for CD. Approximately 20 percent of patients with UC experience active “moderate” or “severe” disease and 50 percent are in remission. Seventy percent of those with active disease of any severity and 30 percent of those in remission will experience episodes in the following year. In CD, 55 percent of patients in remission will have a relapse across the next year, with 11 percent having chronically active disease. Approximately 1.7 million people in the U.S. have IBD, with the total number of cases increasing by 70,000 cases annually. IBD greatly affects a person’s quality of life, including increased emotional distress and a reduced ability to work. Total societal costs, in the U.S. alone, attributable to IBD are estimated to range between $14.6 and $31.6 billion. The considerable economic burden of IBD makes an accurate diagnosis, coupled with effective treatment at the onset of symptoms, a critical component of IBD care. About UP/UPS Ulcerative proctitis (UP), a limited type of ulcerative colitis (UC), is a mucosal inflammatory disease of unknown cause involving only the rectum. When it involves both the rectum and the distal colon, it is called Ulcerative Proctosigmoiditis (UPS). It is characterized by inflammation, redness, and ulcerations of the mucosa. The course of the disease is variable and ranges from complete resolution to easily maintained remission to chronic relapses or refractory disease. Diagnosis can occur at any point in life, with approximately 30-50 percent of patients developing more extensive UC. There is currently no cure. According to estimates provided by GlobalData, the worldwide UC market, which includes products for UP/UPS, is expected to increase at a compound annual growth rate of 4.7 percent, from $4.2 billion in 2012 to approximately $6.6 billion by 2022.  About Cellceutix’s Proof-of-Concept (PoC) UP/UPS Trial Design This trial is being conducted in an overseas hospital/clinic setting with Brilacidin being administered with water in an enema. A foam formulation of Brilacidin for use in future studies is planned and would be expected to improve patient convenience and study results. The primary objective of Cellceutix’s Proof-of-Concept (PoC) trial is to assess the frequency of clinical remission (defined using Modified Mayo Disease Activity Index [MMDAI] scoring) with Brilacidin administered per rectum by enema in patients with active UP or UPS after 6 weeks of treatment. Secondary objectives include: evaluation of safety and tolerability of Brilacidin when administered per rectum; assessment of systemic exposure and/or pharmacokinetics of Brilacidin when administered per rectum; assessment of the efficacy of Brilacidin by change in MMDAI at Day 42/Week 6 and Partial MMDAI during treatment and by biomarker evaluation (from serum, feces, and rectum/sigmoid biopsy samples); evaluation of change in patient-reported quality of life (by the Short Inflammatory Bowel Disease Questionnaire); and estimation of statistical power for subsequent trial(s) in UP and UPS. The PoC trial includes 18 patients divided evenly into three cohorts. Cohort A receives 50 milligrams (mg) of Brilacidin once daily administered per rectum as a retention enema for 42 days. Dosing is increased to 100 mg and 200 mg once daily for 42 days for Cohort B and Cohort C, respectively. Endoscopic evaluation of the rectum and mucosa up to 40 cm from the anal verge is performed at screening and at the end of treatment/Day 42 (± 3 days). Per protocol, a Safety Committee reviews safety and retention data (clinical laboratory findings, vital signs, adverse events, retention times) after 21 days of therapy for all six patients in each cohort before proceeding with initiating enrollment into the subsequent cohort. About Cellceutix 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 first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix’s psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix has commenced a Phase 2 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 lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, 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”). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first two cohorts of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).  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. Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACT

Cellceutix Corporation
Leo Ehrlich
[email protected]

Read more...
Cellceutix Releases Preliminary Efficacy and Safety Data in Interim Analysis of First Two Cohorts in Phase 2 Trial of Brilacidin for the Induction of Remission of Mild-to-Moderate Ulcerative Colitis

BEVERLY, Mass., March 08, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, today announced interim results in the first two cohorts of its ongoing Phase 2a clinical trial of Brilacidin for the induction of remission of mild-to-moderate Ulcerative Colitis. Patient recruitment to the third cohort (highest dose) is currently underway. Patients include those with Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).
The ongoing Phase 2, open-label, Proof-of-Concept (PoC) trial comprises three sequential cohorts (6 patients per cohort), with progressive dose escalation by cohort—50 mg (Cohort A), 100 mg (Cohort B), and 200 mg (Cohort C), respectively. Daily treatment with Brilacidin by enema administration is performed consecutively for 42 days. All twelve (12) patients across the first two cohorts have completed their full dosing schedules in the study. Comparison to baseline after six weeks of treatment showed: All 12 patients experienced a beneficial response, as measured by the Modified Mayo Disease Activity Index (MMDAI).
-- At Day 42, the Primary Efficacy Endpoint of Clinical Remission (accounting for Stool Frequency, Rectal Bleeding, and Endoscopy sub-scores), was met in half (n=6) of all patients (3 of 6 in Cohort A; 3 of 6 in Cohort B).
-- Among the remaining patients (n=6) in Cohorts A and B not meeting all three criteria for Clinical Remission, two of the three criteria were achieved by all of these patients (defined as a Partial Response).Patient Quality-of-Life, as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), was improved in all 12 patients after six weeks of daily Brilacidin treatment. Specifically, over 40 percent of patients reported significant improvements, ranging approximately from 20 points to more than 50 points higher on the 70-point SIBDQ scale.Brilacidin was generally well-tolerated and patients maintained stable normal vital signs during treatment. Measurements of drug concentrations in plasma continued to show limited systemic absorption of Brilacidin, with all values registering less than 100 ng/mL for all six patients in Cohort A and averaging approximately 200 ng/mL maximum concentrations across the six patients in Cohort B.
Patients for Cohort C (200 mg, the highest and final dosing group) are now being enrolled. Further detailed analyses, across all three cohorts once the trial is completed, will establish which dosing level provides the most favorable overall outcomes. Alerts:

Sign-up for Cellceutix email alerts is available at: www.cellceutix.com/email-alerts About Brilacidin
Brilacidin is Cellceutix’s lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, Cellceutix is studying Brilacidin’s effect on oral mucositis (under Fast Track designation) and on ulcerative proctitis/proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: hidradenitis suppurativa and acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.
Learn more here:
http://www.cellceutix.com/brilacidin-1/
About UP/UPS
Ulcerative proctitis (UP), a limited type of ulcerative colitis (UC), is a mucosal inflammatory disease of unknown cause involving only the rectum. When it involves both the rectum and the distal colon, it is called Ulcerative Proctosigmoiditis (UPS). It is characterized by inflammation, redness, and ulcerations of the mucosa. The course of the disease is variable and ranges from complete resolution to easily maintained remission to chronic relapses or refractory disease. Diagnosis can occur at any point in life, with approximately 30-50 percent of patients developing more extensive UC. There is currently no cure. According to estimates provided by GlobalData, the worldwide UC market, which includes products for UP/UPS, is expected to increase at a compound annual growth rate of 4.7 percent, from $4.2 billion in 2012 to approximately $6.6 billion by 2022. About Cellceutix’s Proof-of-Concept (PoC) UP/UPS Trial Design
This trial is being conducted in an overseas hospital/clinic setting with Brilacidin being administered with water in an enema. A foam formulation of Brilacidin for use in future studies is planned and would be expected to improve patient convenience and study results. The primary objective of Cellceutix’s Proof-of-Concept (PoC) trial is to assess the frequency of clinical remission (defined using Modified Mayo Disease Activity Index [MMDAI] scoring) with Brilacidin administered per rectum by enema in patients with active UP or UPS after 6 weeks of treatment. Secondary objectives include: evaluation of safety and tolerability of Brilacidin when administered per rectum; assessment of systemic exposure and/or pharmacokinetics of Brilacidin when administered per rectum; assessment of the efficacy of Brilacidin by change in MMDAI at Day 42/Week 6 and Partial MMDAI during treatment and by biomarker evaluation (from serum, feces, and rectum/sigmoid biopsy samples); evaluation of change in patient-reported quality of life (by the Short Inflammatory Bowel Disease Questionnaire); and estimation of statistical power for subsequent trial(s) in UP and UPS. The PoC trial includes 18 patients divided evenly into three cohorts. Cohort A receives 50 milligrams (mg) of Brilacidin once daily administered per rectum as a retention enema for 42 days. Dosing is increased to 100 mg and 200 mg once daily for 42 days for Cohort B and Cohort C, respectively. Endoscopic evaluation of the rectum and mucosa up to 40 cm from the anal verge is performed at screening and at the end of treatment/Day 42 (± 3 days). Per protocol, a Safety Committee reviews safety and retention data (clinical laboratory findings, vital signs, adverse events, retention times) after 21 days of therapy for all six patients in each cohort before proceeding with initiating enrollment into the subsequent cohort. About Cellceutix

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 first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix’s psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix has commenced a Phase 2 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 lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, 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”). In an ongoing Phase 2 open label Proof-of-Concept trial, interim results have been observed in the first two cohorts of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).  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 at www.cellceutix.com. Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.  

INVESTOR AND MEDIA CONTACT

Cellceutix Corporation
Leo Ehrlich
[email protected]

Read more...
Cellceutix Provides Update on Developing p53 Drug Candidate Kevetrin as an Oral Anti-Cancer Agent

BEVERLY, Mass., March 03, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to update shareholders on continuing efforts to develop the oral dosing of Kevetrin.
Based on positive results from Cellceutix’s Phase 1 trial of Kevetrin in solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, the Company is moving forward with a Phase 2 trial of intravenously-administered Kevetrin in patients with late-stage, platinum-resistant ovarian cancer. Cellceutix has decided to pursue an oral formulation for Kevetrin to improve patient convenience and potentially increase therapeutic efficacy given the drug’s short half-life and other pharmacokinetics, as discussed below. As background, pre-clinical work determined the bioavailability of Kevetrin was 79 percent when given orally in Sprague-Dawley rats. To further establish the efficacy of oral Kevetrin, in vivo mouse studies were carried out in an ascites ovarian tumor model using OVCAR-3 and OV-90 tumor models, both of which possess different mutant p53 genes. Importantly, these pre-clinical results showed that the overall efficacy of Kevetrin was similar across both oral and intraperitoneal routes of drug administration. Cellceutix has initiated a series of GLP (Good Laboratory Practice) studies to assess the safety of Kevetrin given orally. Considering that Kevetrin is a non-cytotoxic drug, our intent, with FDA permission, is to next proceed with a Phase 1 clinical trial in healthy volunteers using the oral route. These studies are being conducted by approved vendors and include: photosafety testing, pharmacokinetics, in vivo metabolism, metabolic stability, protein binding, and genetic and physiological toxicology reports. Preliminary data analyses in a pharmacokinetic study in rats revealed a half-life of approximately 1 hour and a clearance of 78ml/min/kg for both oral and intravenous (IV) dosing. Results of an initial photosafety study demonstrated a molar extinction coefficient value of less than 5 L/mol*cm over a range of wavelengths above 290 nm, well below the 1000 L/mol*cm limit stated in ICH guidelines—indicating Kevetrin has no phototoxicity. A preliminary toxicity study showed that at doses up to 500 mg/kg given orally daily for 7 days, Kevetrin was well-tolerated by the rats as indicated by an 11 percent increase in body weight and no abnormal clinical observations. Further, this dose was greater than the doses used in the preclinical efficacy study. Remaining safety studies will be completed in the second half of this year. In related news: Last week, Cellceutix research partners in Italy shared results with the Company from their ongoing preclinical work evaluating Kevetrin in Acute Myeloid Leukemia (AML), Pancreatic Cancer and human Gliobastoma Multiforme (hGBM). The data will be presented (by them) at scientific conferences, and is consistent with, and further informs, our knowledge of Kevetrin. Also, efficacy data from the 2nd cohort in the Brilacidin-Ulcerative Colitis proof-of-concept study is in the last stage of being compiled by the CRO and, following a final review, will be released. Alerts Sign-up for Cellceutix email alerts at:
http://www.cellceutix.com/email-alerts About Kevetrin Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by inducing activation of p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial evaluating Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response. Cellceutix has initiated a Phase 2a trial of Kevetrin in platinum-resistant/refractory ovarian cancer. Patients will receive more frequent dosing (3 times per week) at higher levels and then receive standard of care treatment. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially even multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma. Learn more here:
http://www.cellceutix.com/kevetrin-1/ About Ovarian Cancer Ovarian cancer is a common type of cancer that commonly begins in women’s ovaries. Malignant ovarian tumor cells metastasize either directly through the organs of the pelvis region, or through the bloodstream, or the lymphatic system. The causes of ovarian cancer are still not known, though women over the age of 63 represent more than 50 percent of newly diagnosed cases, with the cancer more frequently found in white women than other ethnicities. Ovarian cancer ranks fifth in cancer deaths among women worldwide. It is estimated that in 2016, in the United States, over 22,000 women will be diagnosed with ovarian cancer, with approximately 14,000 women dying from the disease. A $1.6 billion market, current treatment is often limited to surgery and chemotherapy and there is no cure. More information can be found at:
https://seer.cancer.gov/statfacts/html/ovary.html About Cellceutix Phase 2a Ovarian Cancer Trial Design CTIX-KEV-201 is an open-label, Phase 2a study evaluating the safety, tolerability, and pharmacokinetics of Kevetrin as well as changes in select biomarkers and objective tumor response when administered to patients with platinum-resistant/refractory ovarian cancer. The clinical trial comprises two different short-term treatment regimens and will enroll an estimated 10 patients. Primary outcome measures include the incidence of Treatment-Emergent Adverse Events (TEAEs) and changes in pre-specified biomarkers (via tumor biopsy, examination of ascites fluid and peripheral blood), pre-treatment and post-treatment, at 3 weeks. Secondary outcome measures include objective tumor response, per Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) and plasma concentrations of Kevetrin. For more information on the CTIX-KEV-201 Phase 2a study, please visit:
https://clinicaltrials.gov/ct2/show/NCT03042702 About Cellceutix 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 first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix's psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix has commenced a Phase 2 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 lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, 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"). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first cohort of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).  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 at www.cellceutix.com.  Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACT

Cellceutix Corporation
Leo Ehrlich
[email protected]

Read more...

Ratios

vs
industry
vs
history
PB Ratio 106.67
CTIX's PB Ratio is ranked lower than
100% of the 844 Companies
in the Global Biotechnology industry.

( Industry Median: 3.75 vs. CTIX: 106.67 )
Ranked among companies with meaningful PB Ratio only.
CTIX' s PB Ratio Range Over the Past 10 Years
Min: 0  Med: 0 Max: 1080
Current: 106.67
0
1080
EV-to-EBIT -9.19
CTIX's EV-to-EBIT is ranked lower than
99.99% of the 423 Companies
in the Global Biotechnology industry.

( Industry Median: 22.87 vs. CTIX: -9.19 )
Ranked among companies with meaningful EV-to-EBIT only.
CTIX' s EV-to-EBIT Range Over the Past 10 Years
Min: -10.43  Med: 0 Max: 0
Current: -9.19
-10.43
0
EV-to-EBITDA -9.97
CTIX's EV-to-EBITDA is ranked lower than
99.99% of the 466 Companies
in the Global Biotechnology industry.

( Industry Median: 17.12 vs. CTIX: -9.97 )
Ranked among companies with meaningful EV-to-EBITDA only.
CTIX' s EV-to-EBITDA Range Over the Past 10 Years
Min: -11.34  Med: 0 Max: 0
Current: -9.97
-11.34
0
Current Ratio 0.62
CTIX's Current Ratio is ranked lower than
94% of the 921 Companies
in the Global Biotechnology industry.

( Industry Median: 4.05 vs. CTIX: 0.62 )
Ranked among companies with meaningful Current Ratio only.
CTIX' s Current Ratio Range Over the Past 10 Years
Min: 0.01  Med: 0.42 Max: 2.4
Current: 0.62
0.01
2.4
Quick Ratio 0.62
CTIX's Quick Ratio is ranked lower than
93% of the 920 Companies
in the Global Biotechnology industry.

( Industry Median: 3.77 vs. CTIX: 0.62 )
Ranked among companies with meaningful Quick Ratio only.
CTIX' s Quick Ratio Range Over the Past 10 Years
Min: 0.01  Med: 0.42 Max: 2.4
Current: 0.62
0.01
2.4

Buy Back

vs
industry
vs
history
3-Year Average Share Buyback Ratio -7.60
CTIX's 3-Year Average Share Buyback Ratio is ranked higher than
63% of the 571 Companies
in the Global Biotechnology industry.

( Industry Median: -11.10 vs. CTIX: -7.60 )
Ranked among companies with meaningful 3-Year Average Share Buyback Ratio only.
CTIX' s 3-Year Average Share Buyback Ratio Range Over the Past 10 Years
Min: -114.3  Med: -8.15 Max: -0.1
Current: -7.6
-114.3
-0.1

Valuation & Return

vs
industry
vs
history
Earnings Yield (Greenblatt) % -10.88
CTIX's Earnings Yield (Greenblatt) % is ranked lower than
59% of the 1272 Companies
in the Global Biotechnology industry.

( Industry Median: -6.37 vs. CTIX: -10.88 )
Ranked among companies with meaningful Earnings Yield (Greenblatt) % only.
CTIX' s Earnings Yield (Greenblatt) % Range Over the Past 10 Years
Min: -16.34  Med: 0 Max: 372.12
Current: -10.88
-16.34
372.12

More Statistics

EPS (TTM) $ -0.11
Beta1.92
Short Percentage of Float0.00%
52-Week Range $0.63 - 1.65
Shares Outstanding (Mil)131.38
» More Articles for CTIX

Headlines

Articles On GuruFocus.com
Cellceutix Provides Corporate Update; Significant Milestones Ahead as Multiple Mid-Phase Clinical Tr May 10 2017 
Cellceutix Announces Details for Upcoming Investor and Shareholder Presentations Apr 19 2017 
Cellceutix CEO Discusses Brilacidin Following Interim Trial Results for Treating Oral Mucositis and Apr 10 2017 
Cellceutix AACR Poster Presents Data Supporting Kevetrin Modulation of p53 in Multiple Human Ovarian Apr 03 2017 
Cellceutix Reports Very Encouraging Interim Analysis of Phase 2 Drug Candidate Brilacidin for Severe Mar 27 2017 
Cellceutix Releases Favorable Topline Findings as Part of Interim Analysis of Phase 2 Drug Candidate Mar 21 2017 
Cellceutix’s Phase 2 Drug Candidate Brilacidin Emerging as a Potential Novel Non-Biologic Thera Mar 16 2017 
Cellceutix Releases Preliminary Efficacy and Safety Data in Interim Analysis of First Two Cohorts in Mar 08 2017 
Cellceutix Provides Update on Developing p53 Drug Candidate Kevetrin as an Oral Anti-Cancer Agent Mar 03 2017 
Federman & Sherwood Announces Filing of Securities Class Action Lawsuit Against Cellceutix Corporati Sep 15 2015 

More From Other Websites
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Cellceutix Releases Favorable Topline Findings as Part of Interim Analysis of Phase 2 Drug Candidate... Mar 21 2017
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Cellceutix’s Phase 2 Drug Candidate Brilacidin Emerging as a Potential Novel Non-Biologic Therapy... Mar 16 2017
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