BEVERLY, Mass., Oct. 26, 2016 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to announce today that the favorable pharmacokinetic profile of Brilacidin in Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) supports Brilacidin’s potential in treating patients in our ongoing, FDA Fast Track-designated, Phase 2 study of Brilacidin-OM as an oral rinse to attenuate Oral Mucositis in patients with Head and Neck Cancer receiving chemoradiation.
As previously reported, initial interim results in UP/UPS, a type of Inflammatory Bowel Disease (IBD), revealed clinically meaningful improvements in the first cohort of four patients treated with Brilacidin at the lowest dose (50mg). Localized treatment with Brilacidin at 50mg by daily enema administration for 42 days produced clinical benefit without measurable plasma drug levels. More specifically, measurements of concentrations of Brilacidin in plasma showed all levels, across all time points, to be below the lower limit of quantification (i.e., <100 ng/mL), which is consistent with limited systemic exposure from administration per rectum by enema.
These data suggest that other inflammatory conditions may, likewise, be treated locally and efficaciously with Brilacidin without significant systemic absorption, better ensuring a safe and well-tolerated therapeutic profile. Given Brilacidin’s low level of systemic exposure, moderate-to-high dosing of the drug by topical application to the skin might also be supported in treating various dermatology disorders and conditions.
Additional reporting of results from the Phase 2 Proof-of-Concept (PoC) clinical trial of Brilacidin-UP/UPS is anticipated over the coming months, as is an interim analysis in the first half of 2017 of the Phase 2 clinical trial of Brilacidin-Oral Mucositis.
“Cellceutix is on the cusp of proving our drug candidates to be truly transformative medicines,” said Jane Harness, Cellceutix VP, Clinical Sciences and Portfolio Management. “The results that we’re already seeing in Inflammatory Bowel Disease are incredibly encouraging, leading us to believe that there is a solid clinical basis to extend Brilacidin into treating multiple indications.”
Other corporate news: The Company will soon be updating clinicaltrials.gov to reflect the planned start of its Phase 2b study of Prurisol, an oral compound for treating moderate-to-severe chronic plaque psoriasis. Prurisol will be tested at higher doses and evaluated using the Psoriasis Area and Severity Index (PASI) scoring method, enabling a direct comparison to approved psoriasis drugs. Regarding the planned Phase 2a study of Kevetrin, a p53-activating anti-cancer agent, in late-stage ovarian cancer, the protocol is undergoing a final internal review before submission to the FDA, a process expected to be completed next month. Communications also continue with the FDA on the Company’s Special Protocol Assessment (SPA) request for its planned Phase 3 clinical trial of single-dose Brilacidin in the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria.
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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.
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) after 6 weeks of Brilacidin treatment administered per rectum by enema in patients with active UP or UPS. 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 will include 18 patients divided evenly into three cohorts. Cohort A is receiving 50 milligrams (mg) of Brilacidin once daily administered per rectum as a retention enema for 42 days. Dosing will be 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 will be performed at screening and at the end of treatment/Day 42 (± 3 days). Per protocol, a safety committee will review 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 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. Affecting over 400,000 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.
About Cellceutix’s Phase 2 Oral Mucositis Trial Design
This ongoing, randomized, double-blind, placebo-controlled trial in the control and prevention of Oral Mucositis (OM) in patients receiving chemoradiation therapy for Head and Neck Cancer is being conducted in the United States, with up to 20 sites participating. The study will be enrolling a total of 60 patients, 30 each given Brilacidin or placebo (water for injection). Brilacidin (16 ml oral rinse—“swish and spit”) will be administered 3 times daily across 7 weeks. Interim analysis reviewing safety and efficacy, conducted by an independent Data Monitoring Committee (DMC), will be completed after 36 patients have received treatment (18 per treatment group). Primary endpoints assessed will include: efficacy of topically-applied Brilacidin versus placebo in delaying the onset of severe OM (WHO Grade ≥ 3); safety and tolerability of topically applied Brilacidin administered 3 times daily across 7 weeks of treatment. Pre-clinical results in animal models showed Brilacidin reduced ulcerative OM by >94 percent. Interim data collection and analysis for the Phase 2 trial of Brilacidin-OM is anticipated to be completed in 2Q2017.
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 anti-psoriasis drug Prurisol completed a Phase 2 trial and Cellceutix is now preparing to launch a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s anti-cancer drug Kevetrin concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its plans for a Phase 2 study. In the laboratory, Kevetrin has been 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 Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
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