SOURCE: Cellceutix

Cellceutix

January 25, 2016 10:00 ET

Cellceutix Phase 2 Trial of New Oral Treatment for Psoriasis Nearing Completion

Top-Line Data on Prurisol Expected in 2nd Quarter

BEVERLY, MA--(Marketwired - January 25, 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 approximately 75 percent of the subjects enrolled in the Company's Phase 2 clinical trial of Prurisol for the treatment of chronic plaque psoriasis have completed dosing, defined as 84 days of daily treatments of Prurisol or placebo. The subjects will now be followed for an additional 4 weeks, without taking any further study medication.

The four-arm multi-center Phase 2 trial, three arms with different dosing regimens of Prurisol and one arm placebo, is designed to assess the efficacy and safety of Prurisol given orally compared to placebo in a randomized, double-blind setting in patients with mild to moderate chronic plaque psoriasis. The trial was expected to enroll 100 subjects and actually enrolled 115 subjects. The primary efficacy endpoint will be the percentage of subjects with greater than or equal to a 2-point improvement in Investigator's Global Assessment (IGA) rating as defined by visual inspections of patient lesions. The final study visit for the last subject is expected early in April 2016, with top-line data anticipated approximately four weeks later.

"The completion of this study of Prurisol will mark another important milestone for Cellceutix. I am very eager to see the unblinded data, as we structured this trial to give us a broad view of the activity of Prurisol in humans," commented Edward Walters, Head of Clinical Operations at Cellceutix. "The goal is to show the compound is safe and effective, while pointing us to an optimal dosing regimen for a late-stage trial. For the good of the millions of people suffering from psoriasis, we hope that Prurisol can one day provide a much-needed option to often-used biologics that are known to have side effects and contraindications, while eventually losing effectiveness in many patients."

More of the Phase 2 study of Prurisol can be found at: https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=2

Alerts:
Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs

Cellceutix clinical trials on Clinicaltrials.gov:

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

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 compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.

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 that 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.

Contact Information

  • INVESTOR AND MEDIA CONTACT:
    Cellceutix Corporation
    Leo Ehrlich
    Email contact