Cellceutix Novel Anti-Inflammatory Phase 2 Drug Candidate Brilacidin Builds Momentum Across Multiple Clinical Indications

BEVERLY, Mass., Oct. 26, 2016 (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 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.

Cellceutix Phase 2 Trial Initial Data Shows Potential of Brilacidin as a Novel Anti-Inflammatory Drug Candidate for Induction of Remission of Mild-to-Moderate Ulcerative Colitis

BEVERLY, Mass., Oct. 10, 2016 (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 announce today interim results observed for the first four patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), a type of Inflammatory Bowel Disease (IBD). Clinically meaningful improvements were demonstrated, as measured by physician assessments, patient reported outcomes and endoscopic evaluation of disease activity.

The ongoing Phase 2, open-label, proof-of-concept trial comprises three sequential cohorts (6 patients per cohort), with progressive dose escalation by cohort—50 mg, 100 mg, and 200 mg, respectively. Treatment with Brilacidin by daily enema administration is performed for 42 days.

Four (4) of 6 patients to date in the lowest dosing cohort (50 mg) have completed the study. Comparison to baseline after 6 weeks of treatment showed:

  • All 4 patients experienced a clinically meaningful response, as measured by the Modified Mayo Disease Activity Index (MMDAI). 
    • At Day 42, on the Partial MMDAI (accounting for Stool Frequency, Rectal Bleeding, and Physician’s Global Assessment scores), 2 of 4 patients achieved full response (100% reduction) and the other 2 patients had notable improvement (50% reduction).
    • At Day 42, on the MMDAI (equivalent to Partial MMDAI + Endoscopy score; completed by 3 of 4 patients), 1 of 3 patients achieved full response (100% reduction) and 2 of 3 patients had notable improvement (50% reduction). One patient who had demonstrated a full response on the Partial MMDAI (as defined in first bullet point) did not consent to the final endoscopy, so their data cannot be included in these initial results.

 

  • At Day 42, on the Partial MMDAI (accounting for Stool Frequency, Rectal Bleeding, and Physician’s Global Assessment scores), 2 of 4 patients achieved full response (100% reduction) and the other 2 patients had notable improvement (50% reduction).
  • At Day 42, on the MMDAI (equivalent to Partial MMDAI + Endoscopy score; completed by 3 of 4 patients), 1 of 3 patients achieved full response (100% reduction) and 2 of 3 patients had notable improvement (50% reduction). One patient who had demonstrated a full response on the Partial MMDAI (as defined in first bullet point) did not consent to the final endoscopy, so their data cannot be included in these initial results.
  • Patient quality of life, as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), was improved after 6-weeks of treatment with Brilacidin.
  • Brilacidin was generally well-tolerated and patients maintained stable normal vital signs during treatment.

For all 4 patients, measurements of drug concentrations 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 very limited systemic exposure from administration per rectum by enema. In comparison, based on a previously completed and successful Phase 2b clinical trial of Brilacidin in the treatment of serious skin infections, maximum concentrations of the drug in plasma administered by intravenous (iv) dosing, ­­at 0.6 mg/kg and 0.8 mg/kg, were approximately 9,000 ng/mL and 12,000 ng/mL, respectively.

“These results are extremely encouraging. They support early clinical validity of the unique immunomodulatory properties of Brilacidin. We anticipate the anti-inflammatory properties of Brilacidin alone will lead to multiple beneficial applications of the drug candidate beyond its already demonstrated effect in antibacterial indications,” said Arthur P. Bertolino, MD, PhD, MBA, Cellceutix President and Chief Medical Officer.

Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “We are delighted to see such promising responses to treatment in the first group of patients given the lowest dose of Brilacidin. The open label design of this trial allowed us to take an early look. Inflammatory Bowel Disease, which affects millions worldwide, poses a real medical need for patients who we hope may eventually benefit from our lead defensin mimetic drug candidate.  The immunomodulatory and anti-inflammatory properties are at the core of effectively treating many diseases and conditions, such as IBDs and oral mucositis.  As we are initiating 2-3 more sites to our ongoing oral mucositis (OM) trial this month and continue to report results from this UP trial, we expect to continue to grow many horizontal and vertical pipeline opportunities with the Brilacidin franchise.”

Continued reporting of results from this ongoing Phase 2 proof-of-concept clinical trial is anticipated over the coming months.

Cellceutix Announces Appointment of Vice President for Regulatory Affairs

BEVERLY, MA--(Marketwired - September 16, 2016) - Cellceutix Corporation, (CTIX)("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, antibiotic, and anti-inflammatory applications, is pleased to announce today the appointment of LaVonne Lang, DrPH, to the role of Vice President, Regulatory Affairs.

Dr. Lang has over twenty-five years of experience in a variety of specialty roles with a focus in several different therapeutic areas in pharmaceutical development. Dr. Lang received a BSN, a MPH (Environmental and Industrial Health: sub-specialty in Toxicology), and a DrPH (Health Management and Policy) from The University of Michigan. She served as study coordinator at the University of Michigan Hospital, overseeing clinical trial research in Pediatric Endocrinology. Upon joining Warner-Lambert Parke-Davis, her work included study director and writer in Pathology and Experimental Toxicology as well as Clinical Communications. As Director of Regulatory Affairs at Parke-Davis/Pfizer, she was therapeutic area lead in gene therapy and dermatology.

For the last seven years, Dr. Lang has been a consultant, providing FDA liaison support and serving as head of regulatory for companies focusing on a variety of therapeutic areas, including cardiovascular, metabolic, and inflammatory disease.

She joins an expanding senior management team at Cellceutix, further complementing the recent hiring of pharmaceutical executive, Arthur P. Bertolino, MD, PhD, MBA, as President and Chief Medical Officer, and Jane Harness, MS, MP, as VP, Clinical Sciences and Portfolio Management.

"I am excited to join Cellceutix," commented Dr. Lang, "and work with this team of professionals to help advance investigational products toward FDA approval in areas that could have a positive impact on the public's health."

"LaVonne is a fantastic addition to our team," said Dr. Bertolino. "With our lead drug candidates approaching pivotal, later-stage FDA trials, LaVonne's leadership in regulatory affairs will be of paramount importance as we continue to work closely with our research partners and the FDA towards further validating our drug candidates. The professional relationships that she has built over the years at the FDA, coupled with her extensive clinical and regulatory knowledge, should help ensure that lines of communication with the agency remain open and productive."

Leo Ehrlich, Chief Executive Officer of Cellceutix added, "The strengthening of our senior management team by adding proven industry veterans will help us execute more expediently all of our business objectives."

Cellceutix Corporation Provides Business Update and Timeline of Upcoming Milestones

BEVERLY, MA--(Marketwired - September 13, 2016) - Cellceutix Corporation (CTIX)("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, antibiotic, and anti-inflammatory applications, today provided a fiscal year-end business update including a timeline of key upcoming milestones.

Leo Ehrlich, Chief Executive Officer, commented, "We are extremely pleased with the tremendous progress that we have made, especially within the last 12 months. We have assembled an attractive portfolio of three unique compounds, each of which addresses very large markets and is supported by strong IP protection. To date, we have met all of the primary endpoints in each of our clinical trials, and we have a number of very important milestones upcoming during the course of the next 12 to 18 months. Many of these milestones have the potential to create a substantial inflection (turning) point in our market cap."             

Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix, commented, "We are making progress advancing Prurisol through the clinical pathway. We completed a Phase 2a trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis in May 2016. The trial successfully achieved its primary endpoint, further validating Prurisol's potential as a novel oral treatment for psoriasis. On the heels of these data, we are now planning our Phase 2b trial of Prurisol for patients with moderate-to-severe plaque psoriasis in order to better define appropriate dosing to achieve greatest clinical responses and we expect to have our interim analysis top-line results in the second quarter of 2017. We believe that the potential safety profile of Prurisol may make this an attractive alternative to Celgene's OTEZLA, which is on its way to achieving $1 billion in sales within just three years of its launch."

"We are also making headway with our Kevetrin asset, which has shown potent anti-tumor activity. Following our Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, we are now preparing for a Phase 2a trial of Kevetrin for treating late stage ovarian cancer. We anticipate that this trial will start in the fourth quarter of this year. Our plan is to conduct a small trial that will provide the critical data necessary to forge a partnership with a large pharmaceutical company that could potentially fund development of Kevetrin through FDA approval. We are encouraged by the guidance and feedback that we have received from potential partners which are incorporated in our Phase 2a trial design."

"Lastly, we completed our Phase 2b trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI, and are moving forward with our Phase 2 clinical trial with Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin has a novel mechanism of action -- robust anti-bacterial as well as anti-inflammatory properties. In fact, a single dose of Brilacidin has been shown to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Moreover, we believe that it will demonstrate a broad spectrum of activity in infectious diseases, gastrointestinal and inflammatory diseases, and a variety of dermatological diseases."

Mr. Ehrlich concluded, "To wrap up, the consistent theme across all of our compounds is strong supporting clinical data and a clear path to delivering a meaningful return on investment. We had previously been largely under the radar of Wall Street and institutional investors, but given our success to-date, we are now engaging in a much more aggressive outreach effort. We have a number of important upcoming milestones, that if successful, we believe will drive meaningful value for shareholders."

Cellceutix Corporation to Present at Upcoming Conferences

BEVERLY, MA–(Marketwired – September 07, 2016) - Cellceutix Corporation (OTC: CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, today announces that management will present at two upcoming conferences highlighting the continuing advancement of the Company’s clinical programs.

  • Friday, September 9, 2016 – Cellceutix will present at the 23rd Annual Newsmakers in the Biotech Industry Conference in New York City at 8:30 am ET. This presentation will be made available in the Investors section of the cellceutix.com website.
  • Monday, September 19, 2016 – Cellceutix will present, and participate in multiple panel discussions, at the 14th Annual Discovery on Target Conference in Boston. The Company’s main presentation is titled, “Prurisol: A New Small Molecule under investigation for the treatment of Psoriasis,” and will be made available in the Investors section of the cellceutix.com website.

Cellceutix Further Expands Its Senior Managment Team With the Addition of an Industry Veteran

BEVERLY, MA–(Marketwired – August 30, 2016) - Cellceutix Corporation (OTC: CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to announce today the addition of another senior executive to its management team. Jane Harness, MS, MP, has been appointed to the role of Vice President, Clinical Sciences and Portfolio Management.

This new hire comes two months after pharmaceutical executive, Arthur P. Bertolino, MD, PhD, MBA, joined Cellceutix as President and Chief Medical Officer.

Ms. Harness is a seasoned industry executive with over 20 years of experience in clinical drug development, which will significantly broaden Cellceutix’s management capabilities going forward.

Ms. Harness will direct all management aspects toward advancing the Company’s pipeline, with a particular focus on clinical trials. Ms. Harness has successfully led numerous teams in executing clinical studies both internationally and domestically. Her expertise spans early and late-phase therapeutic programs at both large pharma, such as Pfizer and Novartis, and at smaller specialty companies. She possesses extensive experience in the areas of Dermatology, as well as Inflammation and Immunology. Ms. Harness has also run clinical trials in other therapeutic areas and has provided key leadership in project management and strategy.

“I am extremely pleased that Jane has joined our senior management team and, by so doing, further validates the Company’s vision for success in developing its portfolio of first-in-class drug candidates,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. “Now is the time for efficient execution of strategies that will help take Cellceutix to the next level in its clinical programs. The addition of Jane to our team is a key operational development toward achieving this end,” said Dr. Bertolino.

Leo Ehrlich, Chief Executive Officer, added, “We recognize the need for Cellceutix to supplement its ranks with accomplished pharmaceutical leaders in order to realize the full potential of our clinical pipeline. With the June 2016 hiring of Dr. Bertolino, followed by the recent employment of Jane, another talented and proven leader, we are establishing a solid foundation for major accomplishments in drug development.”

Cellceutix Prepares Phase 2a Ovarian Cancer Trial of Kevetrin, a Novel p53-Modulating Drug Candidate, Based Upon Phase 1 Topline Data

BEVERLY, MA –(Marketwired – August 03, 2016) - Cellceutix Corporation, (OTCQB: CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to provide topline data on the completed Phase 1 clinical trial of Kevetrin for the treatment of advanced solid tumors, which are among the hardest-to-treat types of cancers.

In the Phase 1 study, conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, Kevetrin, which in a preclinical setting has been shown to activate p53 as measured by increased expression of the protein p21, was evaluated following intravenous (IV) administration. Each patient received one dose each week for three weeks across a four-week cycle. The primary objective of this study was to evaluate safety and tolerability of Kevetrin. Secondary objectives were to determine the pharmacokinetic (PK) profile and assess anti-tumor activity of Kevetrin.

The Phase 1 dose-escalation study, with dosing amounts ranging from 10mg/m2 to 750mg/m2, met its primary endpoint in showing no clinically significant adverse effects of Kevetrin in patients based on clinical laboratory parameters through all dosing levels and across the duration of treatment.

With regards to secondary endpoints, it was determined that Kevetrin has a relatively short apparent biological half-life (less than 2 hr) in plasma. Plasma half-life (T1/2) clearance (CL) and volume of distribution (Vd) suggest that drug elimination predominantly involves hepatic mechanisms and Kevetrin undergoes rapid extensive distribution from systemic circulation into tissues. PK data, as measured by AUC and Cmax levels, further revealed that Kevetrin exhibited a dose-dependent response, has as stated a relatively short half-life (approximately 2 hours) and clears the body within one day – on average between 8 and 10 hours – though the drug can remain in the body up to approximately 24 hours, depending upon individual patient variations.

When the duration of the treatment of a disease is shorter than the therapeutic activity of drug, single doses are given. After a single dose IV infusion administration, plasma drug concentration levels rise above and then fall below the minimum effective concentration (MEC – the minimum plasma drug concentration required to produce a desired pharmacological effect in most patients) resulting in decline in therapeutic effect. To treat cancer, multiple IV infusion regimens are required to maintain the plasma drug levels above the MEC, but below the minimum toxic concentration to achieve optimal clinical effectiveness.

Ideally, a dosage regimen is established for each drug to provide the correct plasma level without excessive fluctuation and drug accumulation outside the therapeutic window. Kevetrin has less than a two-hour half-life.  PK results indicate that with the current dose regimen Kevetrin is almost completely out of plasma within 24 hr. Therefore, little drug remains for any substantial period of time afterwards.

Based on these findings, we believe the impact of Kevetrin when administered to patients with repeated dosing (3 times per week), as planned in the upcoming ovarian cancer trial, will achieve fairly steady levels of Kevetrin above the MEC.  The sustained activation/modulation of p53 will modulate multiple signaling pathways and should substantially increase its therapeutic efficacy.

“Kevetrin is unique in that it is not a chemotherapy and acts by targeting multiple biochemical pathways to control tumor development  in cells with diverse mutational background,  ,” commented Cellceutix CEO Leo Ehrlich.  “Kevetrin has now shown at this stage of its development its enormous potential. We are extremely excited about Kevetrin’s prospects moving forward and feel we have a solid foundation upon which to proceed into advanced trials. To see disease stabilization in this Phase 1 trial with Kevetrin, as previously reported, let alone when optimal dosing has yet to be achieved, is exceptional, and only reinforces what we observed in our preclinical work conducted on animals. That Kevetrin showed clear signs of therapeutic response when it was only in a patient’s body for one day out of seven is encouraging.  Additional lab work in animals is underway to better establish the mechanisms by which Kevetrin activates p53. We believe that establishing these data in the coming human trials will increase the demand for and value of Kevetrin many fold.  We are also now exploring an oral formulation of Kevetrin, with the hope that Kevetrin can develop into a daily medicine for treating and defeating cancer.”

“Our near-term focus is now on preparing for a Phase 2a trial of Kevetrin in treating late-stage ovarian cancer, which we anticipate will start in the fourth quarter this year,” said Cellceutix President and Chief Medical Officer Dr. Arthur P. Bertolino. “This will be a small trial that will move quickly with the end goal to provide the critical data necessary to forge a partnership with a large pharmaceutical company interested in co-developing Kevetrin as it makes progress toward possibly becoming the first p53-activating drug approved by the FDA.”

Cellceutix Expedites Phase 2 Trial of Brilacidin-OM For Oral Mucositis

BEVERLY, MA --(Marketwired - July 21, 2016) - Cellceutix Corporation, (CTIX) ("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to provide additional information in the ongoing, Phase 2 clinical trial of Brilacidin-OM for the treatment of oral mucositis (OM), a serious and debilitating complication of radiation and chemotherapy for head and neck cancer.

Cellceutix has recently retained several experienced OM consultants and embarked on a rapid expansion of the study with a goal of completing its study enrollment on an expedited basis. The Company also has been advised that a competing OM trial, which announced recently that it is being discontinued, has resulted in the availability of a large number of clinical sites, that are being considered to participate in the Cellceutix trial. Cellceutix expansion of the study assures that it will be working with sites and investigators possessing a keen understanding of the unique challenges of OM trials and a proven track record of reliable patient recruitment and retention.

"Cellceutix is committed to completing its ongoing study of Brilacidin-OM for the benefit of patients at risk for developing oral mucositis and we are optimistic that the promising preclinical results from an established and predictive laboratory animal model will be replicated in this study," commented Dr. Arthur P. Bertolino, President and Chief Medical Officer at Cellceutix. "While we can never predict with certainty what will happen when we transition from the laboratory to the clinic, we certainly can take steps to expedite the clinical trial process and maximize the probability of success. We are pleased to have engaged groups with proven track records to get us to the finish line in an efficient and capable manner."

As disclosed on Monday, July 18, 2016, Cellceutix received positive feedback from the first patient treated in a Phase 2 Proof-of-Concept (P-o-C) trial of Brilacidin for ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). While this commentary was only for one patient, it is relevant to Cellceutix management and shareholders, as OM, UP and UPS are all conditions where inflammation plays a significant role. The open-label design of the P-o-C trial, compared to the double-blind design of the OM trial, was the first opportunity for Cellceutix to know with certainty that the subject was treated with Brilacidin. Albeit very early feedback, the Company views the positive feedback as supportive of the anti-inflammatory properties demonstrated in the preclinical research of Brilacidin and the potential for these properties to help patients with OM.

Cellceutix Receives Update on First Patient Enrollment in Phase 2 Proof-of-Concept Study of Brilacidin for Ulcerative Proctitis

Company Encouraged by Investigator Report of Significant Decrease in Symptoms in First Patient in One Week

BEVERLY, MA–(Marketwired – July 18, 2016) - Cellceutix Corporation, (OTCQB: CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to provide additional information in the ongoing, open-label Phase 2 Proof-of-Concept (P-o-C) trial of Brilacidin for the treatment of ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). Brilacidin is being evaluated in adults with active, mild to moderate UP or UPS present for at least three months prior to screening with disease extending at least five centimeters, but no further than 40 centimeters from the anal verge, as confirmed by sigmoidoscopic examination.

Cellceutix has been advised that the first patient in Cohort A remains on study. The clinical site administering Brilacidin to this patient has informed the Company, “Both the patient and the site staff have been amazed how the study drug works as all the symptoms decreased significantly within the 1st week of treatment.”

While impressed and optimistic about the initial feedback, Cellceutix needs to strongly caution that this is limited feedback from only the first patient in the trial and the initial results may not be durable for the patient or indicative of future outcomes in the study.

“The trial being structured as an open-label study lets us know with certainty that Brilacidin was administered to the patient and not a placebo,” commented Dr. Arthur P. Bertolino, President and Chief Medical Officer at Cellceutix. “It’s still very early in the study, but this is the type of investigator feedback that is encouraging to hear. While by no means guaranteeing future results, it lends validation to laboratory research that suggested Brilacidin could provide a clinically meaningful therapeutic benefit for patients with UP, UPS and other inflammatory diseases and conditions. We are hopeful that the initial data will translate to durable and repeated results throughout the first cohort and subjects at higher dosing levels to align us for larger trials in the future.”

Cellceutix considers this early study information important as the Company has made a significant investment in studying the anti-inflammatory and immunomodulatory properties of Brilacidin for several different indications. Due to the pathogenesis of UP and UPS, Cellceutix views this data as strongly encouraging evidence of the anti-inflammatory and immunomodulatory properties of Brilacidin in the clinical setting. The data are pertinent with respect to not only inflammatory bowel conditions, but also to the ongoing, double-blind Phase 2 trial of Brilacidin-OM, where the combination of these properties is expected to deliver a clinical benefit to prevent and treat oral mucositis in patients receiving chemoradiation for head and neck cancer.

UP/UPS Trial Design

The primary objective of the P-o-C trial is to assess the frequency of clinical and endoscopic remission with Brilacidin administered per rectum in subjects with active UP or UPS after 6 weeks of treatment. Secondary objectives include evaluation of safety and tolerability of Brilacidin when administered per rectum, evaluation of clinical remission at Week 2 and Week 4, assessment of systemic exposure and/or pharmacokinetics of Brilacidin when administered per rectum, assessment of the efficiency of Brilacidin by biomarker evaluation of biopsy samples for interleukin (IL)-6 and IL-1beta, and estimation of statistical power for subsequent trial(s) in UP and UPS.

The P-o-C trial will include 18 patients divided evenly into three cohorts. Cohort A is receiving 50 milligrams (mg) of Brilacidin once daily for 42 days. Dosing will be increased to 100mg and 200mg 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 and adverse events) after 21 days of therapy for all six patients in each cohort before proceeding with initiating enrollment in the subsequent cohort.

Cellceutix to Initiate Phase 2b Trial of Prurisol for Chronic Plaque Psoriasis

BEVERLY, MA–(Marketwired – July 07, 2016) - Cellceutix Corporation, (OTC: CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to provide shareholders information on the next phases of clinical and corporate development following the recent appointment of Arthur P. Bertolino, MD, PhD, MBA as President and Chief Medical Officer.

“As I become even more familiar with the Cellceutix staff and pipeline, I continue to see a great deal of value and potential in our three lead compounds: Kevetrin, Brilacidin and Prurisol,” commented Dr. Bertolino. “I am working full-time with our team to define succinct clinical development strategies to advance these programs in a manner proven successful in my previous pharmaceutical experiences. My current emphasis is centered on efficient drug development and recruiting additional leading industry veterans for our staff and advisory board to assist in these matters. I believe this will translate into sustainable value for our company.”

Since successfully completing the initial Phase 2 trial of oral Prurisol for mild to moderate plaque psoriasis, the Company has fielded inquiries from many interested parties about the compound and has evaluated several options for the next stage of development. After a detailed analysis, the data clearly show that the most robust response to Prurisol was in patients with moderate psoriasis in the trial’s highest dosing arm (200mg), with no serious adverse events reported. Benefits were apparent by two weeks and showed further improvement by the end of the study at 12 weeks.

Cellceutix has begun preparing for a Phase 2b trial of Prurisol for patients with moderate to severe plaque psoriasis in order to better define appropriate dosing to achieve greatest clinical responses. The Company intends to increase the dosing beyond 200mg and evaluate patients using the Psoriasis Area and Severity Index (PASI) scoring method, which will enable better comparison to approved psoriasis drugs, including apremilast and biologics. In addition to evaluating efficacy in moderate to severe psoriasis, multiple secondary endpoints will be studied to provide insights regarding additional potential benefits of Prurisol compared to approved therapies. Our expectations are to initiate the trial late in the third quarter or early in the fourth quarter with top-line results in the second quarter of 2017.

“There is a significant opportunity in successfully developing a potent oral drug for chronic psoriasis. The spectrum of current treatment options spans multiple injectable biologics, oral apremilast, and a variety of topical creams,” said Dr. Bertolino. “A new oral drug that delivers substantial efficacy should command considerable market value and further attract the attention of pharmas looking to expand their dermatology offerings. I believe that Prurisol has that potential and that a refined second successful Phase 2 trial would further anchor the value that we already appreciate.”

“As we further define plans in the coming weeks for the development of Brilacidin and Kevetrin, we intend to also provide shareholders with additional updates on our clinical and pre-clinical program strategies,” concluded Dr. Bertolino.

Cellceutix Corporation Announces Industry Veteran Arthur P. Bertolino, MD, PhD, MBA Joins Company as President and Chief Medical Officer

BEVERLY, MA--(Marketwired - June 30, 2016) - Cellceutix Corporation, (CTIX) ("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, today announces the appointment of Arthur P. Bertolino, MD, PhD, MBA, as President and Chief Medical Officer. Dr. Krishna Menon will continue to serve as Chief Scientific Officer and President of Research at Cellceutix. Dr. Bertolino is a leading pharmaceutical executive with over fifteen years of domestic and international drug development and management experience. Dr. Bertolino's responsibilities will include, but are not limited to, day-to-day operations for all aspects of the Company, including pipeline development, cohesion of clinical and business strategies, team building and exploration of partnering opportunities.

In his career, Dr. Bertolino held several key positions at Novartis Institutes for Biomedical Research (NIBR), including Vice President of Dermatology and Vice President & Global Head of Translational Medicine for Dermatology. During his time at NIBR, Dr. Bertolino was integral to the marketing approval of Ilaris® (canakinumab) in the United States, European Union and Switzerland. He also led the early clinical program of Cosentyx™ (secukinumab) and late stage supportive submission studies. Further, he successfully recruited an additional six physicians to the Novartis team and contributed to other hires in NIBR.

Dr. Bertolino held positions as Senior Medical Director and Senior Director of Dermatology at Pfizer, Inc. Among other accomplishments at Pfizer, he led clinical programs for over a half-dozen new chemical entities involving Phase 1 and Phase 2 studies and contributed to planning for Phase 3 studies. Dr. Bertolino led FDA clinical interactions at entitlement meetings for Pfizer's dermatology products and served as Pfizer's dermatology spokesperson.

Dr. Bertolino served as Chief Medical Officer and Vice President of Medical Affairs at Peplin, Inc., where he led Phase 2 programs and designed and drove initial Phase 3 programs that contributed to FDA approval of Picato® (ingenol mebutate). Dr. Bertolino also held the position of Executive Vice President and Chief Medical Officer at Revance Therapeutics, where he, among other responsibilities, supervised all aspects of clinical staff and programs and regulatory affairs.

Dr. Bertolino earned a BS in Chemistry/Biochemistry from SUNY Stony Brook, an MD and PhD in Pharmacology from The Johns Hopkins University School of Medicine, and an MBA from the University of Michigan Stephen M. Ross School of Business. He has authored over 50 abstracts, papers, and book chapters, and also has been a contributor to major media broadcasts and print media, such as Nightline, Nova, CBS This Morning, Men's Health, GQ, Discover and more.

"With several of our compounds in or approaching mid- and late-stage development, we are assembling a team of industry veterans with a track record of bringing drugs to market. Art is an important first addition in these efforts as we recruit and negotiate with other industry leaders to advance our novel therapies for patients in need around the world. He brings exceptional clinical and corporate leadership and regulatory expertise, having spearheaded multiple development programs for drugs forecasted to be blockbusters for some of the world's most recognized pharmaceutical companies," commented Chief Executive Officer Leo Ehrlich. "Art will play a pivotal role as we seek to realize the global potential of the entire Cellceutix pipeline."

Dr. Bertolino commented, "I am excited to join Cellceutix. While many professional opportunities were presented to me, I saw Cellceutix as the best fit and an exciting opportunity to lead the advancement of what I believe are some very promising drug candidates. The Company's pipeline is world-class, with compounds that can transform lives. I look forward to helping Cellceutix deliver on its vast potential."

Cellceutix Starts Phase 2 Trial of Brilacidin as a Novel Therapy for Ulcerative Proctitis

BEVERLY, MA--(Marketwired - June 15, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, today announces that patients have been screened and the administration of Brilacidin to patients is expected to begin this week in the Phase 2 Proof of Concept trial of Brilacidin for the treatment of ulcerative proctitis.

Given its robust anti-inflammatory properties, Brilacidin offers patients a promising non-corticosteroid alternative to current clinical treatments. Long-term use of rectal corticosteroids should be avoided, as it can produce potentially serious side effects.

The ulcerative proctitis trial is planned to enroll 18 adult patients with Brilacidin administration through retention enema at three different concentrations once daily at bedtime for a 6-week (42-day) period. 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). All endoscopic evaluations (screening and Day 42) will be photographed and videotaped for eventual adjudication by an independent observer (a gastroenterologist) who is blinded to the day of on-treatment endoscopy and the dosage of Brilacidin used. This process of blinded adjudication (assessing overall results) will be performed after the study's completion and will not delay patient enrollment.

Designed as a Proof of Concept trial based on considerable pre-clinical work, the study's primary goal is the remission of the condition. A successful Proof of Concept ulcerative proctitis trial would be a key step in advancing the Brilacidin franchise into other inflammatory bowel diseases. The 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 further studies is in development.

The Company is excited to see this important study commence. We are hopeful that Brilacidin can prove itself to be a new treatment for patients with ulcerative proctitis and look forward to Brilacidin possibly emerging as a novel therapy for the millions of patients suffering from this and other difficult-to-treat inflammation-based gastrointestinal conditions. Should this trial deliver encouraging results, Brilacidin's treatment of ulcerative colitis and Crohn's disease likely would be warranted.

About Ulcerative Proctitis 

Ulcerative proctitis, a mild form of ulcerative colitis, is a mucosal inflammatory disease of unknown cause involving only the rectum or the distal colon and the rectum (proctosigmoiditis). It is characterized by rectum inflammation, redness, and ulcerations of the lining of the rectum. 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 ulcerative colitis. There is currently no cure. According to estimates provided by GlobalData, the worldwide ulcerative colitis market, which includes products for ulcerative proctitis and ulcerative proctosigmoiditis, 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 Brilacidin

Brilacidin is the first of a completely new class of antibiotics called defensin-mimetics. Modeled after the body's innate host-defense response, Brilacidin kills bacteria quickly and efficiently, penetrating bacterial cell wall membranes. Given this mechanism-of-action, resistance is much less likely to develop. Beyond its robust antimicrobial properties, Brilacidin also functions in an immunomodulatory capacity, lessening inflammation and promoting healing.

Cellceutix Announces Dismissal of Class Action Lawsuit Filed by Rosen Law Firm

BEVERLY, MA--(Marketwired - June 09, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that, yesterday, the U.S. District Court for the Southern District of New York granted the Company's motion to dismiss the securities class action lawsuit brought against the Company by a plaintiff represented by the Rosen Law Firm.

The ruling dismisses all claims against Cellceutix, denies the plaintiff's request to file an amended complaint, and orders that the case be closed. Writing on behalf of the Court in a 39-page ruling, the Honorable Judge Katherine Polk Failla dismissed the lawsuit in its entirety (Case 1:15-cv-07194-KPF), concluding:

For the reasons stated in this Opinion, Defendants' motion to dismiss Plaintiff's SAC [Second Amended Complaint] is GRANTED. Plaintiff has requested leave to replead, without presenting any concrete means of remedying the deficiencies identified in this Opinion. Because Plaintiff has previously been given leave to replead, and because the Court finds that any further repleading would be futile, Plaintiff's request is DENIED. See Loreley Fin. (Jersey) No. 3 Ltd. v. Wells Fargo Sec., LLC, 797 F.3d 160, 190 (2d Cir. 2015) (identifying futility as a proper ground for denying leave to replead); see generally United States ex rel. Ladas v. Exelis, Inc., - F.3d -, No. 14-4155-cv, 2016 WL 3003674, at *9 (2d Cir. May 25, 2016). The Clerk of Court is directed to terminate all pending motions, adjourn all remaining dates, and close this case.

"We are extremely pleased with Judge Failla's decision," commented attorney Michael J. Sullivan, lead counsel for Cellceutix and former U.S. Attorney for the District of Massachusetts. "From the outset, of this case, it was our opinion that the claims were both meritless and frivolous, so we were gratified that after careful consideration, to see Judge Failla agree to dismiss this case in its entirety. An anonymous libelous article caused this case to be filed. The author intended and in fact caused the price of Cellceutix's stock to decline. This type of manipulation of publicly traded stock is illegal and causes harm to companies and investors. We continue to work with regulators, prosecutors and law enforcement to assist in identifying the anonymous individuals and organizations intent on manipulating the value of a company's stock by publishing dishonest articles in online forums, and other venues. Such 'short and distort' tactics are illegal, detrimental to our securities markets, and must stop."

"We are extremely pleased with the ruling," stated Leo Ehrlich, Chief Executive Officer of Cellceutix. "I greatly appreciate the work of the Ashcroft Law Firm. They never wavered in their support, and put forth a zealous defense of our Company against these baseless claims. Frivolous class action lawsuits are a huge burden on the biotech industry, negatively impacting shareholders and patients alike. Not only is a company materially damaged, but promising treatments and cures under development are put at greater risk of not making it to market. These actions caused significant damage to our Company and shareholders. We hope that the dismissal of this case and all its ramifications sends a powerful signal to others to think twice about pursuing such actions."

The Court's opinion dismissing the lawsuit can be found on http://cellceutix.com/wp-content/uploads/2015/08/49-Memo-Opinion-and-Order-MTD-GRANTED.pdf

About The Ashcroft Law Firm

The Ashcroft Law Firm was founded by former U.S. Attorney General, Governor and Senator John Ashcroft, and has offices in Boston, MA, Washington, DC, St. Louis, MO, and Austin, TX. See http://ashcroftlawfirm.com/ for more information.

Cellceutix clinical trials on Clinicaltrials.gov:

https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search

Cellceutix Announces Database Lock in Phase 1 Trial of Kevetrin, a Promising New Cancer Treatment that Activates p53

BEVERLY, MA–(Marketwired – June 06, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to announce that the study database from the Phase 1 trial of Kevetrin (thioureidobutyronitrile) for advanced solid tumors will be “soft locked” this week. These locked results are the final protocol requirement for the study of Kevetrin in its next clinical trial and will be added to the already prepared documentation for submission to the U.S. Food and Drug Administration (“FDA”) in support of the planned Phase 1b/2 trial of Kevetrin in ovarian cancer patients with resistance to platinum-based therapies. Cellceutix is developing Kevetrin under an Orphan Drug designation from the FDA.

The first-in-human clinical trial evaluating the safety and pharmacokinetics of Kevetrin was conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The study enrolled a total of 48 patients, who had failed previous therapies, with various types of advanced solid tumors, including 11 patients with advanced ovarian cancer. A dose-escalation design was used with patients enrolled in 11 cohorts with the maximum dose administered at 750 mg/m2. Kevetrin was shown to be safe and well-tolerated, with no dose-limiting toxicities occurring among patients who received even the highest dose of Kevetrin.

Kevetrin has a unique multimodal mechanism of action. The drug enhances the activity of p53, a key tumor suppressor protein often referred to as the “Guardian Angel” gene, in both wild type and mutant p53-expressing tumors. In the majority of advanced ovarian cancer patients, p53 is inactive because of genetic mutations. In the completed trial, the hospital measured p53 activity by increased expression of the protein p21, a downstream biomarker of p53, in peripheral blood lymphocytes. Samples were collected from patients at 7 and 24 hours after the initiation of the first Kevetrin infusion.

Preliminary data has been very encouraging. As previously released, regardless of tumor type, a total of 27 of 40 evaluable patients (67.5%) had an increase in p21 expression relative to pre-treatment levels. For patients with the greatest increases at either 7 hours or 24 hours, the mean percent increase at 7 hours (10 patients) was 38.5% (median 22%) and at 24 hours (17 patients) the mean percent increase was 24.5% (median 17%). For those patients who received Kevetrin at doses of ≤ 165 mg/m2, the mean percent increase was 21.7% (n=11). And for patients who received Kevetrin at doses ranging from 215 mg/m2 to 750 mg/m2, the mean percent increase was 35.2% (n=17). Concerning ovarian cancer in particular, analyses showed increased p21 expression in 8 of 11 (73%) patients.

The above data confirm the ability of Kevetrin to activate p53. The trial also validates the short half-life of Kevetrin in plasma. In an earlier February 2016 meeting with the FDA, the FDA agreed that a regimen of multiple doses each week is an appropriate approach. In the Phase 1 trial, patients received Kevetrin only once a week. In the planned Phase 1b/2 ovarian cancer trial, Cellceutix intends to treat patients three times weekly, with the expectation that multiple doses will enhance p53 activity and, thus, result in a corresponding improvement in therapeutic benefit. Patients will receive Kevetrin in combination with a currently approved chemotherapy (doxorubicin), as related laboratory studies produced extremely encouraging data-results that the Company hopes will continue to translate in the clinic.

“This data lock is exactly what we’ve been waiting for,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “It has been a long road, but we enrolled more patients and completed more cohorts than anyone originally expected. Underscoring this success was the strong safety profile and promising pharmacokinetic activity exhibited by Kevetrin in its first human trial. That leading scientists monitoring the study, as well as other clinical professionals both within the academic community and pharmaceutical industry, continue to want to learn more about our lead oncology drug also speaks to its potential.”

Leo Ehrlich continued: “Cellceutix certainly has diversified its pipeline over the years, but I joined this company with the intent of finding a new cancer drug after losing both my parents to the disease. Cellceutix, to date, has a perfect record of achieving success in all its clinical trials, meeting each trial’s primary endpoint. We attribute this to the rigorous study of our drugs in the laboratory setting before entering clinical trials. I’m thrilled to be moving forward with what I believe can truly become a breakthrough therapy in cancer treatment. And I am confident that by leaving the academic setting, Kevetrin’s potential in treating various cancers will be realized much more quickly.”

Cellceutix clinical trials on Clinicaltrials.gov:https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search

Cellceutix Releases Pharmacokinetics Data from Phase 2 Trial of Prurisol for Treating Psoriasis; Data Complements Efficacy Data Reported Last week

BEVERLY, MA–(Marketwired – May 31, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to announce that the pharmacokinetics (PK) data on the recently completed Phase 2 trial of Prurisol as a novel oral treatment for plaque psoriasis has been received and is starting to be analyzed.

PK Data Complements Efficacy Data

The PK data complements the efficacy data reported last week by showing a dose-dependent increase in exposure and maximum plasma concentration of the drug. Further, the elimination half-life was similar in each of the three dosing levels (50mg, 100mg, 200mg), with an average of 1.3 hours. The clearance of the drug was also similar across dosing levels, with an average of 80.1 liters per hour.

Of particular note, the half-life of Prurisol is shorter than that of apremilast (Otezla®) (1.3 hours vs. 6 to 9 hours). This suggests Prurisol, which acts through immunodulatory mechanisms, may not be dependent upon long-term exposure in the body to exhibit activity. A shorter half-life also may play a role in minimizing side effects commonly observed with other psoriasis treatments. The longer the drug remains in the body, the greater potential for adverse interactions with other medications and foods.

Low Patient Dropout Rates

Patient withdrawals (also called discontinuance) from study arms, whether active or placebo, are often an indicator of general patient satisfaction or dissatisfaction of the drug under study. Additional data analyses revealed a higher dropout rate among patients on placebo compared to patients receiving Prurisol. The Company interprets this as a clear indicator of patient satisfaction.

Coupled with Prurisol’s strong safety profile, minimal-to-no side effects, this insight reinforces qualitative endorsements expressed by many trial participants who reported feeling that their skin was moist, and not as dry, during the trial, as compared to before — an insight providing rationale for possible expansion of Prurisol into other dermatological areas, including atopic dermatitis, or eczema.

Cellceutix clinical trials on Clinicaltrials.gov:

https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search

Cellceutix Provides Additional Insight into Successful Phase 2 Trial for Treating Psoriasis

BEVERLY, MA–(Marketwired – May 26, 2016) Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, today provides additional insight into the successfully completed Phase 2 trial of Prurisol as a new oral therapy for mild to moderate plaque psoriasis.

As disclosed on May 24, 2016 (http://cellceutix.com/cellceutix-phase-2-trial-of-prurisol-for-mild-to-moderate-psoriasis-meets-primary-endpoint/#sthash.s7T0r6y3.dpbs), the trial enrolled 115 patients with mild to moderate plaque psoriasis, graded at a score of 2 (“mild”) or 3 (“moderate”) on the 5-point Investigator’s Global Assessment (IGA) scale. The IGA scale ranges from a score of 0 (“clear”) to a score of 4 (“severe”). The 12-week trial was structured with four arms, three receiving different dosing regimens of oral Prurisol (50mg, 100mg, 200mg) and one placebo arm. The primary endpoint was a 2-point reduction in the IGA score at Day 84.

Complete details of the Prurisol trial can be found at:

https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=2.

New Information: Greatest Efficacy Seen in Patients with Moderate Psoriasis

As previously released, the trial achieved its primary endpoint in patients treated with 200mg of oral Prurisol. Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg. This data was derived from analyses of all patients randomized across all 9 participating study sites.

Additional preliminary data analyses of secondary endpoints show patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point improvement (using the IGA scoring system) at a higher rate than that of patients in the placebo arm. This is another clear indication of the drug’s efficacy. Increases in Prurisol’s therapeutic response, upon evaluating patients at Day 56 (Week 8) and Day 84 (Week 12) of treatment, also were apparent in the Prurisol 200mg arm, suggesting an improving response over time.

In light of Prurisol’s greater efficacy in treating moderate psoriasis cases, the Company expects the next clinical trial of Prurisol will target patients with moderate to severe psoriasis, with an optimal dosing regimen continuing to be assessed.

Prurisol Offers Psoriasis Sufferers a Potential New Treatment

Cellceutix is extremely proud of the Phase 2 Prurisol results. Simply put, the drug’s efficacy compares favorably with many current and various types of treatments for psoriasis (see the study linked to below), including apremilast or Otezla®, which is the leading oral FDA approved anti-psoriasis drug. It is interesting to do a side-by-side comparison between the two based on publicly available literature, and it could be argued that Prurisol performs on par with, if not better than, Otezla® at the identical stage of development

Verguo T (2016) New Therapeutic Agents for Psoriasis. M J Derma 1(1): 002.

Leo Ehrlich, Cellceutix Chief Executive Officer, commented: “Until now, Prurisol has largely been an unknown compound among many in the national psoriasis community. The completed Phase 2 study, with its compelling results, is starting to change that. We are now eager to advance Prurisol into its next FDA trial, for moderate to severe psoriasis, where we believe the drug may show even greater efficacy in treating this debilitating condition that affects millions of people. Should Prurisol go on to gain FDA approval, psoriasis sufferers, the world over, would stand to benefit greatly.” 

About Prurisol

Prurisol is a small molecule that acts through immune modulation and PRINS reduction. In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis and in a xenograft model using human psoriatic tissue. Prurisol eliminated virtually all signs of psoriasis with no reoccurrence of the lesions. Prurisol is synthesized through a five-step process using commercially available starting materials.

About Prurisol’s 505(b)(2) Pathway

Under the FDA’s 505(b)(2) regulatory pathway, a drug’s road to market approval can be significantly shortened and at much reduced costs. Often only one pivotal Phase 3 study, enrolling a smaller number of patients than is typical, may be required. As well, the drug is eligible for up to five years of market exclusivity post-approval. For more information about the FDA’s 505(b)(2) program, please visit:

http://www.fda.gov/downloads/Drugs/…/Guidances/ucm079345.pdf

Cellceutix Phase 2 Trial of Prurisol for Mild to Moderate Psoriasis Meets Primary Endpoint

- Clinical efficacy demonstrated in the highest dose (200mg) comparator arm

- Compound shown to be safe and well-tolerated with a dose-related response

- Oral delivery often preferred among patients, increasing adherence to treatment

- Additional studies planned in moderate to severe psoriasis and eczema

BEVERLY, MA–(Marketwired – May 24, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to inform shareholders that topline data from the Company’s Phase 2 FDA trial of orally-administered Prurisol in the treatment of mild to moderate chronic plaque psoriasis have been compiled and reviewed. The trial successfully achieved its primary endpoint, further validating Prurisol’s potential as a novel oral treatment for psoriasis.

Study Background

Enrolling 115 patients, the placebo-controlled, randomized, double-blind trial tested the efficacy and safety of three separate, twice-daily, dosing regimens of Prurisol—50 milligram (mg) (50mg QD), 100mg (50mg BD), and 200mg (100mg BD). All patients were assessed via the 5-point Investigator’s Global Assessment (IGA) scale, ranging from a score of 0 (“clear”) to a score of 4 (“severe”). The IGA scale is preferred by the U.S. Food and Drug Administration (FDA) and is comparable to the older and more commonly used Psoriasis Area and Severity Index (PASI) in evaluating psoriasis severity of patients, with many dermatologists preferring it in the clinical trial setting. Generally, an IGA score of 0/1 demonstrates a strong association with a PASI 90 score.

For more information comparing the IGA and the PASI psoriasis scoring systems, please see the link immediately below. Two additional links have been provided summarizing recent dermatological studies by Regeneron and Anacor that used the IGA scale.

            http://www.ncbi.nlm.nih.gov/pubmed/24354461

            http://newsroom.regeneron.com/releasedetail.cfm?ReleaseID=963078

            http://investor.anacor.com/releasedetail.cfm?releaseid=921668

Entry criteria for the study required: a total Body Surface Area (BSA) affected by plaque psoriasis of 10 percent to 20 percent; a baseline IGA score of 2 (“mild”) or 3 (“moderate”); and the identification of a target psoriatic lesion with a score greater than or equal to 3 based on a different (than the IGA) lesion-specific 5-point scoring scale. Clinical signs that psoriasis is clearing typically are more noticeable in patients with a greater severity of symptoms. This translated into a rigorous and aggressive study design for the Prurisol trial.

The primary endpoint assessed was the percentage of patients achieving at least a 2-point improvement from baseline on the IGA 5-point scale as measured by visual inspection of patient lesions at the end of the 84-day (12-week) treatment period. In effect, given the entry criteria, participants had to at least obtain an IGA score of “clear” or “almost clear” skin, dropping to 0 or 1 after starting from a baseline of 2 or 3. Secondary endpoints included additional improvement measures tied to degree of patient response at various time intervals.

Results Summary

The Phase 2 Prurisol trial, while not powered to demonstrate statistical significance, was conducted to inform any future fully-powered Phase 3 trial(s) that might be merited. As a result, the study’s main goal was to provide indications of efficacy, safety and tolerability upon treating patients with mild to moderate plaque psoriasis via oral delivery.

Overall analyses showed Prurisol, which is being developed under the FDA’s 505(b)(2) program, to be superior to placebo in the 200mg arm. Pharmacokinetics/Pharmacodynamics (PK/PD) further revealed an early (by week 8) dose-related response that improved as treatment duration increased.

Evaluating the primary endpoint at 84-days (week 12) in the 200mg arm, 35.0% of the patients receiving that dose of Prurisol demonstrated clinically significant improvements compared with 16.7% of patients on placebo only. This percentage includes patient data from one site where investigator non-compliance may have occurred. Were that site to have been excluded from overall data analysis, as is done in some clinical studies (refer to the journal article linked to below, published findings from another psoriasis study), 43.7% of patients in the 200mg Prurisol arm would have met the primary endpoint. Patient responses in the 50mg and 100mg arms were statistically comparable to the placebo arm.

            http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4229025/

For purposes of direct comparison, the Prurisol trial outperformed a similarly designed Phase 2b trial in the treatment of mild to moderate psoriasis conducted in 2011 by Anacor Pharmaceuticals in which a topical anti-inflammatory compound was assessed. See the link below.

            http://investor.anacor.com/releasedetail.cfm?releaseid=587511

Sub-population analyses further showed greater efficacy demonstrated in patients who had a baseline IGA score of 3 (“moderate”) as compared to those with a baseline score of 2 (“mild”). Some of these patients even experienced a 3-point reduction in their IGA score, going from “moderate” to “clear.” This suggests Prurisol may be more effective in treating moderate to severe psoriasis patients to a greater degree than those patients who exhibit less severe symptoms. In moderate to severe psoriasis studies, the placebo response also tends to be lower.

Regarding Prurisol’s safety profile, only a single Serious Adverse Event (SAE) was reported in the study, that being in the 50mg arm, with the type and the rate of occurrence of additional Adverse Events (AEs) similar and evenly distributed across all the three dosing arms and the placebo arm.

Additional detailed data review and analysis is underway and an end-of-Phase 2 meeting with the FDA will be requested to help determine the dose(s) and design for future studies, which may include higher dosing regimens to determine Prurisol’s maximum therapeutic effect. The Company plans to release other summary findings from this trial in the coming months, with full results anticipated to be submitted for journal publication and presentation at a future medical congress.

Investigator Comments

Cellceutix would also like to share some observations and comments from Principle Investigators (PIs) overseeing different participating clinical sites in the trial. Numerous PIs noted patients expressed a desire to have access to Prurisol following the study’s conclusion. Moreover, the Company learned that some patients were previously unsuccessfully treated with other therapies, including biologics and apremilast (Otezla®).

Included below is a sampling of responses that were authorized to be published:

  • “Well designed study, patients were pleased, minimal to no side effects."
  • “Good tolerability was shown with very few AEs reported. Good compliance and good patient satisfaction.”
  • “Overall impression of the study is very positive, as well as the patients’ satisfaction.”
  • When asked, “Why would you choose Prurisol (should it be approved) over another oral compound for psoriasis?” and “Why would you choose Prurisol over an injectable biologic?” responses included:
  • “Because [Prurisol] does not cause any severe side effects. Patients dislike needles and injections because they cause pain and discomfort."
  • “Patients overall prefer oral medications over injectable medication. Our experience with injectable studies for other indications has been that many subjects do not like taking them and those studies tend to be difficult compared to oral medications to recruit subjects.”
  • “Because of [Prurisol’s] low side effect profile.”
  • “Patients prefer oral treatments.”

Sponsor Comments

Cellceutix believes that the results from the Prurisol Phase 2 trial are extremely encouraging, especially for the 80 percent of psoriasis sufferers exhibiting milder symptoms of the condition. These people are more likely to switch between therapies or be off treatment altogether. Planning is underway to explore Prurisol’s potential in the treatment of moderate to severe psoriasis and eczema, a skin condition experienced by up to 30 percent of children and 10 percent of adults. The Company is hopeful Prurisol may one day become a leading treatment for psoriasis regardless of disease severity.

Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “We had always wanted to explore Prurisol’s clinical merit, as it had excellent results in laboratory studies. We put it to the test under some of the most demanding conditions, with respect to the IGA versus PASI scoring systems; short treatment duration; low dosing levels; enrollment that included patients who were previously treated with biologics; and evaluation in mild to moderate psoriasis patients, where it can be more difficult to achieve a meaningful therapeutic effect. To see such a strong response among patients, achieving clear to almost clear skin without serious side effects—the downside of biologics—in such a short period of time, is exceptional. We would like to thank patients and investigators who participated in the study. Prurisol has taken a key step towards potentially becoming only the second oral treatment approved by the FDA for psoriasis in decades.”

Leo Ehrlich continued: “More broadly, these outstanding results are the first of what we hope are more to come as the Cellceutix pipeline continues to progress. With our three lead drugs, Prurisol, Brilacidin, and Kevetrin, now in later-stage FDA trials, each a possible first-in-class treatment, we are thrilled with what the future holds.”

About Psoriasis

Affecting an estimated 125 million people worldwide, psoriasis is a chronic immune-mediated skin disorder presenting with varying symptoms and levels of severity. The condition is characterized by raised and inflamed patches of skin, often on the elbows, knees, scalp, hands and feet, and causes itching, irritation, stinging and pain. Often feeling socially stigmatized, over 80 percent of people with psoriasis report it negatively impacts the quality of their everyday life. Mild cases are defined as affecting less than 3 percent of the body’s surface area, with a majority of cases limited to less than 2 percent of the skin. Moderate psoriasis covers 3 to 10 percent of the skin. If it covers 10 percent of the body, the disease is considered severe. Up to 40 percent of psoriasis patients will develop psoriatic arthritis (PsA) within 7 to 12 years. Psoriasis also is associated with numerous comorbidities, ranging from cardiovascular disease, autoimmune disease, and cancer to psychological disorders. Despite recent advances, there remains a need for orally-delivered psoriasis drugs, and other treatment alternatives to biologics, which are known to have serious side effects and contraindications, and generally lose their effectiveness over time. Additional information can be found by reading the World Health Organization’s (WHO) 2016

Global Report on Psoriasis: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf

 About Prurisol

Prurisol is a small molecule that acts through immune modulation and PRINS reduction and has completed a Phase 2 FDA trial under the U.S. Food and Drug Administration’s 505(b)(2) pathway. In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis and in a xenograft model using human psoriatic tissue. Prurisol eliminated virtually all signs of psoriasis with no reoccurrence of the lesions. Prurisol is synthesized through a five-step process using commercially available starting materials.

About 505(b)(2) Designation

Under the FDA’s 505(b)(2) regulatory pathway, a drug’s road to market approval can be significantly shortened and at much reduced costs. Often only one pivotal Phase 3 study, enrolling a smaller number of patients than is typical, may be required. As well, the drug is eligible for up to five years of market exclusivity post-approval.

For more information about the FDA’s 505(b)(2) program, please visit:

http://www.fda.gov/downloads/Drugs/…/Guidances/ucm079345.pdf

Cellceutix clinical trials on Clinicaltrials.gov:

https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search

Data from Phase 2 Trial of Prurisol for Psoriasis to be Unblinded Next Week, Top-Line Results to Follow

BEVERLY, MA–(Marketwired – May 11, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the clinical database for the Phase 2 clinical trial of Prurisol for the treatment of mild-to-moderate chronic plaque psoriasis is expected to be “unblinded” next week. Once the blind is removed, data from each of the four arms of the trial (one placebo arm, three oral dosing regimens of Prurisol) will be reviewed and analyzed to evaluate the safety and efficacy of Prurisol. Cellceutix expects to release top-line data from the study approximately one week after the blind is removed.

Separately in Cellceutix’s dermatology pipeline, the Company last month reactivated a request for a Pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) to discuss initiating clinical research of Brilacidin, Cellceutix’s lead defensin mimetic, for the treatment of the inflammatory skin condition hidradenitis suppurativa. Cellceutix previously filed the request, ultimately electing to hold off on clinical studies of Brilacidin for dermatological uses until several other clinical trials sponsored by the Company were completed or neared completion. Cellceutix anticipates the meeting to transpire in June 2016 and will be submitting a Briefing Book to the FDA on the planned trial one month prior to the meeting.

More on the Phase 2 trial of Prurisol can be found on Clinicaltrials.gov:

https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=2

Cellceutix Successfully Completes In Vitro Study in Support of Planned Phase 2 Trial of Kevetrin for Ovarian Cancer

Research on CYP450 Shows No Concerns for Adverse Drug-Drug Interactions in Combination Therapy

Beverly, MA–Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the latest laboratory research on the Company’s anti-cancer drug Kevetrin showed that Kevetrin did not inhibit or induce cytochrome P450 enzymes in vitro.  Based upon the documented relationship of P450 and certain potential drug-drug interactions, this positive data is central to the planned Phase 2 clinical trial where Kevetrin will be used in a combination therapy for the treatment of ovarian cancer.

The testing was performed at the request of the U.S. Food and Drug Administration (“FDA”) during Cellceutix’s recent meeting with the FDA pertaining to the planned Phase 2 trial.  Per standard protocol, the FDA requires specific studies in an attempt to preempt possible drug interaction complications during human trials.  The requisite in vitro testing met Cellceutix’s expectations in demonstrating that Kevetrin can be combined with another anti-cancer drug without any concerns of adverse drug-drug interactions.

Enzymes produced by cytochrome P450 genes are involved in the synthesis and metabolism of molecules within cells. Cytochrome P450 enzymes (CYP450), found primarily in liver cells, account for 70 to 80% of enzymes involved in drug metabolism (US National Library of Medicine, 2016).  There are more than 50 enzymes, but only six metabolize 90% of drugs, especially CYP3A4 and CYP2D6 (Lynch and Price 2007).

Many drugs are metabolized through the CYP450 enzyme system, which can be inhibited or induced by other molecules, such as anti-cancer drugs, grapefruit juice or tobacco. It is important to know if a molecule inhibits or induces these enzymes, especially when used in combination with other drugs, since there is a potential for drug-drug interaction that can cause unexpected adverse events or inactivity (Ogu and Maxa 2000).

Kevetrin, under development as an anti-cancer agent as monotherapy or in combination with chemotherapeutic agents, was assessed for its ability to inhibit or induce P450 enzyme activity.

For assessment of inhibition of CYP450, Kevetrin, at concentrations up to 100 μg/mL, were incubated with human liver microsomes and enzyme-specific substrates at 37°C. The following CYP450 isozymes were evaluated: 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4. Kevetrin showed little to no inhibition and no time dependent inhibition (TDI) effect on any of the seven isozymes tested, whereas the positive controls showed inhibition of the isozymes in the same system, as expected.

For assessment of induction of CYP450, Kevetrin, at 10 and 100 μM, and positive inducers were incubated with primary human liver cells at 37°C for 48 hours. The following CYP450 isozymes were evaluated: 1A2, 2B6, 2C9, 3A4. Enzyme-specific substrates were added, incubated for one hour then metabolites were measured.  Kevetrin did not induce any of the four CYP isozymes tested, whereas the positive controls did show induction in the same system, as expected.

Given the lack of inhibition or induction of CYP450, the study met the requirements of the FDA and it is expected that the development of Kevetrin in human clinical trials may proceed in combination with certain other chemotherapeutic agents without concern for potential drug-drug interactions.  Cellceutix is currently finalizing the documentation for submission to the FDA.

Cellceutix Receives Preliminary Approval for Clinical Trial of Brilacidin for Ulcerative Proctitis

BEVERLY, MA–(Marketwired – March 30, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the Company has received initial approval for the planned Proof of Concept, Phase 2, clinical trial of Brilacidin for ulcerative proctitis.

The local ethics committee, responsible for oversight and allowance of the trial, granted this approval, so the trial can now move forward. Cellceutix is now awaiting the country’s Ministry of Health permission so it may begin exporting Brilacidin into the country and directly to the clinical sites. The location of the trial isn’t currently being disclosed for competitive reasons.

“The ethics committee approval was the first key step in initiating the next developmental stage of Brilacidin, evaluating it in patients with ulcerative proctitis disease,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “We are optimistic that the various properties of Brilacidin will help relieve patient pain and discomfort tied to inflammation and ulcerations — common symptoms that characterize ulcerative proctitis. This clinical trial is the third indication for Brilacidin and will provide us with valuable data as we continue to expand the list of possible uses for our potent compound.”

GlobalData, a research and consulting firm, estimated the global ulcerative colitis market, including products for ulcerative proctitis and ulcerative proctosigmoiditis, to increase at an annual rate of 4.7 percent, from $4.2 billion in 2012 to $6.6 billion by 2022.

“We strongly believe that Brilacidin can improve clinical outcomes of ulcerative proctitis patients as a non-corticosteroid treatment with anti-inflammatory benefits,” commented Dr. Kirshna Menon, Chief Scientific Officer. “Furthermore, ulcerative proctitis may prove to be a gateway indication for the larger ulcerative colitis markets — potentially demonstrating Brilacidin as a viable treatment for various gastrointestinal diseases, including Crohn’s disease.”

The Company will next update the public on this trial once patient enrollment begins at the trial site.

Separately, Cellceutix would like to inform shareholders that its Chief Medical Officer, Dr. Daniel Jorgensen, will be leaving Cellceutix, effective March 31, 2016, in order to pursue a unique opportunity in his specialized field at a privately held company. “I thank Dan for all his hard work and his accomplishments bringing our ABSSSI studies this far. He has worked diligently with our CRO (for the planned Phase 3 ABSSSI study). They already have selected the first sites for the study that can start once we get the final protocol approval from the FDA. I wish him and his family well in his new endeavor,” said Mr. Ehrlich. “Our previous Chief Operating Officer, Dr. James Alexander, who still actively consults for Cellceutix, will help us on clinical matters previously handled by Dr. Jorgensen. We believe Cellceutix is now becoming so much more than an oncology or antibiotic drug company. And we expect to be a big part of the solution in developing better drugs for gastro-intestinal diseases and dermatology as well. A lot of good things are happening. The future is bright.”

 About Ulcerative Proctitis

Ulcerative proctitis, a mild form of ulcerative colitis, is a mucosal inflammatory disease of unknown cause. It is characterized by rectum inflammation, redness, and ulcerations of the lining of the rectum. 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 to 50 percent of patients going on to develop ulcerative colitis. There currently is no cure.

About Brilacidin

Brilacidin is the first of a completely new class of antibiotics called defensin-mimetics. Modeled after the body’s innate host-defense response, Brilacidin kills bacteria quickly and efficiently, penetrating bacterial cell wall membranes. Given this mechanism, resistance is much less likely to develop. Beyond its robust antimicrobial properties, Brilacidin also functions in an immunomodulatory capacity, lessening inflammation and promoting healing.