Cellceutix Corp (OTCMKTS:CTIX) shares were up 1.83% to $1.11 on Friday and flat in after-hours trading. Share prices have been trading in a 52-week range of $0.95 and $1.96. The company has a market cap of $14.92 million at 125.11 million shares outstanding.
In a press release early last week, Cellceutix Corp announced that it has begun the screening of patients in its Phase 2b clinical trial of oral Prurisol. This clinical trial is a randomized, double-blind, parallel-group, placebo-controlled study with approximately 189 patients anticipated to be enrolled at approximately 30 sites throughout the United States.
Treatment groups include oral Prurisol 300mg per day, oral Prurisol 400mg per day, and placebo for a treatment duration of 12 weeks or 84 days. There will be a post-treatment follow-up four weeks after the end of the treatment.
In particular, Phase 2b of this 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, which can be used to gauge its relative efficiency compared to other drugs. Aside from that, 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.
Arthur P. Bertolino, MD, PhD, MBA, Cellceutix President and Chief Medical Officer also noted that this study is a key milestone for our psoriasis program, which hopefully brings them closer to Phase 3 registration. The results of the Phase 2b study will further build upon the positive Phase 2 data reported earlier this year, eventually offering an oral drug that delivers substantial efficacy, expanding choices for treatment, should command considerable market value and add value for Cellceutix Corp shareholders.
“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,” added cellceutix corp ceo Leo Ehrlich.
Cellceutix Corp anticipates conducting an interim analysis of 6-week data from this Phase 2b trial in chronic plaque psoriasis with readout available in the second quarter of next year and full study top-line results by the third quarter.
Cellceutix Corp is a clinical-stage biopharmaceutical company that is engaged in developing therapies with oncology, dermatology and antimicrobial applications. Cellceutix owns the rights to various drug compounds. This includes Kevetrin, its anti-cancer compound, Prurisol, which is in development for psoriasis, and Brilacidin, which is its drug in a class of compounds known as defensin-mimetics.
The company’s clinical trials focus on evaluating its drug candidates, including Kevetrin for the treatment of cancers; Prurisol for the treatment of psoriasis, and Brilacidin for treatments of skin infections, prevention of oral mucositis complicating chemoradiation treatment for cancer, and ulcerative proctitis. It focuses on developing small molecule therapies to treat diseases in the areas of cancer, antibiotics and inflammatory disease.