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

BEVERLY, MA--(Marketwired - May 24, 2016) -

• 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

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.