Cellceutix Corporation (CTIX) Commences Oral Prurisol Phase 2b

October 31, 2016 3:13 PM EDT

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Cellceutix Corporation, (OTC: CTIX) announced that it has begun the screening of patients in its Phase 2b clinical trial of oral Prurisol for the treatment of moderate-to-severe chronic plaque psoriasis.

This clinical trial is a randomized, double-blind, parallel-group, placebo-controlled study with approximately 189 patients anticipated to be enrolled. Treatment groups include oral Prurisol 300mg per day, oral Prurisol 400mg per day, and placebo (3:1:3 randomization, respectively). Duration of treatment is 12 weeks (84 days), with a post-treatment follow-up appointment 4 weeks after the end of treatment. The study is being conducted at approximately 30 sites throughout the United States.

This Phase 2b study increases the total daily dosing of Prurisol above 200mg, the maximum level used in our previously successful Phase 2 trial, which showed the drug candidate to be a promising treatment for psoriasis. Primary efficacy will be evaluated using the Psoriasis Area and Severity Index (PASI), enabling a more direct comparison to already approved psoriasis drugs. In addition, multiple secondary endpoints will be studied to provide further insights into the potential benefits of Prurisol compared to marketed therapies, both oral and biologic.

“We look forward to efficient execution of this important trial for our psoriasis program. Having partnered with one of the premier CROs in the Dermatology therapy area for this study, I am confident that we will be able to assess interim and final study results in a timely fashion,” said Jane Harness, Cellceutix VP, Clinical Sciences and Portfolio Management.

“The start of this study is a key milestone for our psoriasis program, bringing us closer to the Phase 3 registration program, and its results will further build upon the positive Phase 2 data reported earlier this year,” said Arthur P. Bertolino, MD, PhD, MBA, Cellceutix President and Chief Medical Officer. “A new oral drug that delivers substantial efficacy, expanding choices for treatment, should command considerable market value and add value for our shareholders.”

Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “This study is yet another example of the momentum emerging across our clinical portfolio of first-in-class drug candidates. Cellceutix continues to deliver diverse milestones. As to the Dermatology therapy area, multiple recent acquisitions by Big Pharma of companies with innovative therapies convince us that the Company’s strategic positioning is significantly strengthened as we make progress in this area.”

Cellceutix anticipates conducting an interim analysis of 6-week data from this Phase 2b trial in chronic plaque psoriasis with readout available in 2Q2017 and full study top-line results in 3Q2017.



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