SOURCE: Cellceutix

Cellceutix

March 01, 2016 09:30 ET

Cellceutix Completes Dosing in Phase 2 Trial of Prurisol for Chronic Psoriasis, Top-Line Data Anticipated in May

BEVERLY, MA--(Marketwired - March 01, 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 dosing has been completed in the Company's Phase 2 trial of Prurisol for the treatment of mild to moderate chronic plaque psoriasis. Approximately 7.5 million people in the U.S. are diagnosed with some form of psoriasis, a chronic immune-mediated skin disorder presenting with varying symptoms and levels of severity.

Based on compelling pre-clinical data, Cellceutix purposely set the bar high for the Phase 2 trial by targeting mild to moderate plaque psoriasis with an oral drug. By doing this, the Company is assessing Prurisol potentially for two different and very large markets in the psoriasis space. First, there are currently limited oral medications for mild to moderate chronic plaque psoriasis. Second, there is a need for new non-biologic oral treatments for moderate to severe chronic plaque psoriasis. Various trial endpoints will be studied once the trial is completed.

In the Phase 2 trial, physicians selected and evaluated a specific lesion while the patient was treated with a Prurisol or placebo tablet, as opposed to treating the lesion with a cream or gel, a common method used in clinical trials for the treatment of mild to moderate chronic plaque psoriasis.

"As the trial is a randomized, double-blind design with a placebo arm, we, nor anyone, can speculate on the outcome until all data is collected, un-blinded and analyzed." commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "Should the trial be a success, our plan is to seek a partnership through discussions with parties that have previously shown interest in Prurisol." 

Cellceutix is developing Prurisol under the U.S. Food and Drug Administration's 505(b)(2) pathway, which can help expedite a drug's approval by relying, in part, on clinical data from an already approved drug.

The randomized, double-blind Phase 2 trial for chronic psoriasis is designed to evaluate the safety and efficacy of Prurisol as compared to a placebo. In a four-arm, multi-center trial, three arms of the study were administered different dosing regimens of oral Prurisol and one arm was administered an oral placebo for a period of 84 days. The subjects will now be followed for an additional 28 days without taking additional study medication. The final study visit and data collection for the last subject is expected to be completed by early April 2016, with top-line data made available approximately four weeks later. The primary endpoint to be evaluated is 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's target lesion.

More information about the Phase 2 Trial of Prurisol for Chronic Psoriasis

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

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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 compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its FDA application for a Phase 2 ovarian cancer study. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's 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.

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Contact Information

  • INVESTOR AND MEDIA CONTACT:

    Cellceutix Corporation
    Leo Ehrlich
    Email contact