BEVERLY, Mass., Oct. 31, 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 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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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 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.
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.
About 505(b)(2) Development Approach
Under the FDA’s 505(b)(2) development approach, a drug candidate’s road to market approval can be significantly shortened and conducted at a much reduced cost. Long-term safety data from a reference drug may be relied upon for approval, and potentially only one pivotal Phase 3 study, enrolling a smaller number of patients than is typical, may be required to establish efficacy. For more information about the FDA’s 505(b)(2) development program, please visit: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm079345.pdf
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 first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix’s psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix has now launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s anti-cancer drug Kevetrin successfully 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 plans for a Phase 2 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 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”). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed for the first four patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), a type of Inflammatory Bowel Disease (IBD). 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.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Last updated on: 01/11/2016
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