Cellceutix Reports 24 Core Phase 2b Clinical Trial Sites for Oral Prurisol Treatment of Moderate-To-Severe Psoriasis Initiated and Open for Screening

BEVERLY, MA – Dec. 19, 2016 (GLOBE NEWSWIRE) Cellceutix Corporation, (OTCQB: 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 24 of the 25 (all US based) core Phase 2b clinical trial sites for oral Prurisol in the treatment of moderate-to-severe psoriasis have now been initiated and are open for screening, with the last site anticipated to follow later this week. The availability of the additional sites beyond those that have already begun to treat active study participants is expected to greatly facilitate timely completion of full enrollment.

This Phase 2b study increases the total daily oral dosing of Prurisol from a previous high of 200 mg, which earlier was shown to be well-tolerated, to include oral Prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization, respectively). The trial is a randomized, double-blind, parallel-group, placebo-controlled study with approximately 189 patients anticipated to be enrolled. Treatment duration is 12 weeks (84 days), with a post-treatment follow-up appointment 4 weeks after the end of treatment.

Primary efficacy will be evaluated using the Psoriasis Area and Severity Index (PASI). Multiple secondary endpoints will also be studied to provide further insights into the potential benefits of Prurisol compared to marketed therapies, both oral and biologic. Interim analysis of 6-week data with readout is anticipated in 2Q2017, with full study top-line results in 3Q2017.

“We are very excited to have already completed a successful Phase 2a trial with very encouraging results and now look to this Phase 2b trial set the stage for what we believe will be anchoring data to guide our Phase 3 psoriasis program,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix.

Cellceutix believes now is an opportune time to be developing an oral treatment for moderate-to-severe plaque psoriasis. Currently approved treatment options are limited, with many of them not easily administered and often associated with undesirable side effects. The dermatology space has become extremely active recently with multiple large licensing deals and acquisitions speaking both to the market need in the therapy area and a growing demand among Big Pharma to fill their drug development pipelines. Above all, Cellceutix remains committed to improving the lives of patients.

Cellceutix will be presenting a corporate overview at the upcoming 2017 Biotech Showcase in San Francisco. The senior management team will be available to participate in one‐on‐one meetings at select times on January 9th and 10th. Conference attendees who are interested in scheduling a meeting are encouraged to sign up through the conference's portal, link provided below, or by emailing Cellceutix at conference@cellceutix.com

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About Prurisol

Acting through immune modulation and PRINS reduction, Prurisol is a novel dermatology compound currently in mid-stage development as an oral psoriasis treatment utilizing the advantages of the FDA's 505(b)(2) development approach. This regulatory approach helps expedite a drug candidate’s approval as it allows the FDA to rely, in part, on existing clinical data from an already approved drug, in this instance, Ziagen. 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. In these models, Prurisol eliminated virtually all signs of psoriasis. Cellceutix has successfully completed a Phase 2 clinical trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis. Overall analyses showed that the drug candidate appears to be safe, well-tolerated and efficacious in the highest dosing arm (200 mg) across 12 weeks of treatment. Patients with moderate psoriasis saw the greatest clinical improvements. An early (by week two) dose-dependent response that improved as treatment duration increased was observed. Cellceutix has initiated a Phase 2b clinical trial of Prurisol in moderate-to-severe psoriasis and will be assessing the drug candidate’s efficacy at higher dosing regimens, 300 mg and 400 mg, respectively.

Details on the ongoing Phase 2b clinical trial for oral Prurisol in the treatment of moderate-to-severe psoriasis can be found at:

https://clinicaltrials.gov/ct2/show/NCT02949388

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 skin, often on the elbows, knees, scalp, hands and feet, causing 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. Cases are graded as Mild, Moderate and Severe depending upon extent of body surface area involved as well as other parameters. Up to 30 percent of psoriasis patients will eventually develop psoriatic arthritis (PsA). Psoriasis also is associated with numerous comorbidities. Despite recent advances, there remains a need for orally-delivered psoriasis drugs and other treatment alternatives to biologics, which can be accompanied by side effects that significantly impact activities of daily living, and may lose their effectiveness over time.