Cellceutix Provides Corporate Update; Significant Milestones Ahead as Multiple Mid-Phase Clinical Trials Set to Conclude

BEVERLY, Mass., May 10, 2017 (GLOBE NEWSWIRE) — Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory and antibiotic applications, today is pleased to provide a corporate update on current operations and upcoming clinical milestones across its pipeline of First-in-Class drug candidates, Prurisol, Kevetrin and Brilacidin, as summarized in our recent Quarterly Report (Form 10-Q), available for download at the link below.


Clinical Highlights and Upcoming Milestones

  • This week Cellceutix anticipates enrolling the final subjects for the Brilacidin 42-day UP/UPS clinical study. 
  • Between patients already enrolled and those presently in screening, Cellceutix has reached over 70 percent of the anticipated number of trial participants in its Phase 2b trial of Prurisol for the treatment of moderate-to-severe chronic plaque psoriasis.  Interim analysis top-line results are expected during the third quarter of calendar 2017.
  • Interim analysis of patients in the Phase 2 trial of Brilacidin-OM who received at least 55 Gy cumulative units of radiation showed that Brilacidin markedly reduced the rate of Severe OM (WHO Grade ≥ 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent).
  • Concurrent with the Phase 2 clinical trial of intravenous-administered Kevetrin for late-stage ovarian cancer, toxicology studies are ongoing with the purpose of developing an oral formulation of Kevetrin for treating solid tumors.  Currently, there are no approved p53-modulating cancer drugs, much less in pill form.

Prurisol—Psoriasis: Interim Analysis of Phase 2b trial (3Q2017).

The ongoing randomized, double-blind, parallel-group and placebo-controlled study (see NCT02949388) increases the total daily oral dosing of Prurisol from a previous high of 200 mg, which earlier was shown to be well-tolerated and efficacious, to include oral Prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization). Enrolling approximately 189 patients with moderate-to-severe chronic plaque psoriasis, treatment duration is 12 weeks (84 days). Interim analysis is planned at 6 weeks. Currently, between patients already enrolled and those presently in screening, the Company has reached over 70 percent of the anticipated number of trial participants. Efficacy is being evaluated using the Psoriasis Area and Severity Index (PASI). Cellceutix believes now is an opportune time to develop an oral treatment for psoriasis. Currently approved treatments, including injectable biologics, are limited, with many options costly, not easily administered, associated with undesirable side-effects and/or diminishing effectiveness over time. A novel psoriasis drug, particularly one that is oral, safe and effective, which could expand patient and physician choices for treatment, likely would command significant market value.

Learn more here:

Kevetrin—Ovarian Cancer: Completion of Phase 2a trial (2H2017).

The ongoing open-label study (see NCT03042702) is evaluating intravenous (IV) administration of Kevetrin 3 times per week, over 3 weeks, at an initial dose of 250mg/m2, with dose escalation in the 2nd cohort, in patients with platinum-resistant ovarian cancer. Modulation of the p53 pathway to further inform Kevetrin’s mechanism of action (MOA) is being measured via various RNA and protein biomarkers. Endpoints will include safety, efficacy (based on RECIST criteria) and pharmacodynamics. Running in parallel, the Company continues to make substantial progress in developing Kevetrin as an oral formulation. Preliminary bioavailability and other laboratory studies are encouraging and support its potential as an oral formulation. Currently there are no approved p53-modulating drugs, much less in pill form. An oral formulation of Kevetrin one day could position the drug candidate as a go-to cancer treatment.

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Brilacidin—Oral Mucositis: Completion of Phase 2 trial (2H2017).

The ongoing randomized, double-blind, placebo-controlled study (see NCT02324335) is evaluating Brilacidin as an oral rinse, 3 times daily for 7 weeks, to prevent and control Oral Mucositis (OM) in patients receiving chemoradiation therapy for Head and Neck Cancer. Even though over 450,000 patients in the U.S. suffer from this condition, presently there are no approved drugs for the treatment of OM in this population, with only limited palliative care options available. In March 2017, preliminary interim analysis revealed that Brilacidin markedly reduced the occurrence of Severe OM, defined as Grade > 3 on the World Health Organization OM Grading Scale—only 2 of 9 patients (22.2%) receiving Brilacidin developed Severe OM compared to 7 of 10 (70%) patients on placebo. Cellceutix’s goal with this trial is to show that Brilacidin has dual functionality in preventing the onset of the condition and shortening the duration of OM, an accomplishment no other pharmaceutical company has achieved.

Brilacidin—Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS): Completion of Phase 2a trial (2Q2017).

The ongoing open-label, proof-of-concept trial includes enrolling 18 patients treated with Brilacidin divided evenly into three cohorts (6 patients per cohort)—Cohort A (50 mg); Cohort B (100 mg); Cohort C (200 mg). In March 2017, after Cohorts A and B were completed (presently, three patients in Cohort C have completed their treatment), Cellceutix released the interim results. The Primary Efficacy Endpoint of Clinical Remission (accounting for Stool Frequency, Rectal Bleeding and Endoscopy Findings subscores) was met by 50 percent of patients in Cohort A (3 of 6) and 50 percent of patients in Cohort B (3 of 6); all 6 of the remaining patients in Cohorts A and B had a Partial Response, as they met 2 of the 3 specified criteria. Brilacidin was generally well-tolerated. Patient Quality of Life (as assessed by the Short Inflammatory Bowel Disease Questionnaire, SIBDQ) showed notable improvements in all 12 patients. Limited systemic exposure to Brilacidin was demonstrated as measured by plasma Brilacidin concentrations. These data, along with the OM findings, suggest that other inflammatory conditions may, likewise, be treated locally and efficaciously with Brilacidin.

Learn more here:

Financial Highlights

Cash Position—As of March 31, 2017, the Company had approximately $5.6 million in cash and $16 million remaining available for stock sales under the terms of the purchase agreement with Aspire Capital, compared to $6.3 million of cash as of June 30, 2016.

Shelf Registration—The Company has in place an effective shelf registration statement on Form S-3, registering the sale of up to $75 million of the Company’s securities, with approximately $42.8 million remaining available.

Management Discussion—The Company anticipates that future budget expenditures will be approximately $14 million over the next 12 months, including approximately $10 million for clinical trials. Management believes that financing available from Aspire Capital and under the Company’s effective Form S-3 shelf registration statement as well as any potential future Form S-1 filing to register the sale of its securities will be sufficient to fund the Company’s operations for the next 12 months.

“We are extremely proud of our accomplishments to date and are thrilled at the company’s prospects going forward into the latter half of 2017,” said Leo Ehrlich, Chief Executive Officer of Cellceutix. “Within a matter of months, we anticipate completing multiple mid-phase clinical trials for indications in areas with serious unmet medical needs. Based on highly encouraging clinical data received so far, we look forward to sharing complete clinical results with shareholders, members of the pharmaceutical industry interested in our drug candidates, and the public at large, to further establish the true potential of our clinical pipeline.”

“Much-needed drugs and tremendous value creation await patients and shareholders alike should we continue to deliver compelling trial results,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix.

Upcoming Events

Cellceutix reminds shareholders and other interested parties of two upcoming events.

First, on June 8, 2017, at 11AM EST, the Company will hold a live shareholder and investor conference call. We are fielding questions in advance, which may be submitted by emailing conference@cellceutix.com and must be received by June 1, 2017 at 5pm EST. Dial-in instructions for participants will be announced one week prior.

Second, the Company will be presenting topline findings from the Brilacidin-UP/UPS trial as well as additional interim data from its Phase 2 trial of Brilacidin for Oral Mucositis at Drug Discovery and Therapy World Congress 2017, to be held July 10 – 13, 2017, in Boston. More details to come.

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About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly-traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. Cellceutix believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix’s psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix has commenced a Phase 2 study. In the laboratory, Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. 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 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; interim results have shown a marked reduction in the incidence of severe oral mucositis (WHO Grade ≥ 3). Cellceutix’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first two cohorts of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.

Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

Cellceutix Corporation
Leo Ehrlich