SOURCE: Cellceutix

Cellceutix

May 26, 2016 07:00 ET

Cellceutix Provides Additional Insight Into Successful Phase 2 Trial for Treating Psoriasis

BEVERLY, MA--(Marketwired - May 26, 2016) -  Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, today provides additional insight into the successfully completed Phase 2 trial of Prurisol as a new oral therapy for mild to moderate plaque psoriasis.

As disclosed on May 24, 2016 (http://cellceutix.com/cellceutix-phase-2-trial-of-prurisol-for-mild-to-moderate-psoriasis-meets-primary-endpoint/#sthash.s7T0r6y3.dpbs), the trial enrolled 115 patients with mild to moderate plaque psoriasis, graded at a score of 2 ("mild") or 3 ("moderate") on the 5-point Investigator's Global Assessment (IGA) scale. The IGA scale ranges from a score of 0 ("clear") to a score of 4 ("severe"). The 12-week trial was structured with four arms, three receiving different dosing regimens of oral Prurisol (50mg, 100mg, 200mg) and one placebo arm. The primary endpoint was a 2-point reduction in the IGA score at Day 84.

Complete details of the Prurisol trial can be found at: https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=2.

New Information: Greatest Efficacy Seen in Patients with Moderate Psoriasis

As previously released, the trial achieved its primary endpoint in patients treated with 200mg of oral Prurisol. Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 ("moderate"), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg. This data was derived from analyses of all patients randomized across all 9 participating study sites.

Additional preliminary data analyses of secondary endpoints show patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point improvement (using the IGA scoring system) at a higher rate than that of patients in the placebo arm. This is another clear indication of the drug's efficacy. Increases in Prurisol's therapeutic response, upon evaluating patients at Day 56 (Week 8) and Day 84 (Week 12) of treatment, also were apparent in the Prurisol 200mg arm, suggesting an improving response over time.

In light of Prurisol's greater efficacy in treating moderate psoriasis cases, the Company expects the next clinical trial of Prurisol will target patients with moderate to severe psoriasis, with an optimal dosing regimen continuing to be assessed.

Prurisol Offers Psoriasis Sufferers a Potential New Treatment

Cellceutix is extremely proud of the Phase 2 Prurisol results. Simply put, the drug's efficacy compares favorably with many current and various types of treatments for psoriasis (see the study linked to below), including apremilast or Otezla®, which is the leading oral FDA approved anti-psoriasis drug. It is interesting to do a side-by-side comparison between the two based on publicly available literature, and it could be argued that Prurisol performs on par with, if not better than, Otezla® at the identical stage of development.

Verguo T (2016) New Therapeutic Agents for Psoriasis. M J Derma 1(1): 002.

Leo Ehrlich, Cellceutix Chief Executive Officer, commented: "Until now, Prurisol has largely been an unknown compound among many in the national psoriasis community. The completed Phase 2 study, with its compelling results, is starting to change that. We are now eager to advance Prurisol into its next FDA trial, for moderate to severe psoriasis, where we believe the drug may show even greater efficacy in treating this debilitating condition that affects millions of people. Should Prurisol go on to gain FDA approval, psoriasis sufferers, the world over, would stand to benefit greatly."

About Prurisol

Prurisol is a small molecule that acts through immune modulation and PRINS reduction. 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. Prurisol eliminated virtually all signs of psoriasis with no reoccurrence of the lesions. Prurisol is synthesized through a five-step process using commercially available starting materials.

About Prurisol's 505(b)(2) Pathway

Under the FDA's 505(b)(2) regulatory pathway, a drug's road to market approval can be significantly shortened and at much reduced costs. Often only one pivotal Phase 3 study, enrolling a smaller number of patients than is typical, may be required. As well, the drug is eligible for up to five years of market exclusivity post-approval. For more information about the FDA's 505(b)(2) program, please visit: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm079345.pdf

Cellceutix clinical trials on Clinicaltrials.gov:

https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search

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About Cellceutix:
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 compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin 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 FDA application for a Phase 2 ovarian cancer 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 anti-psoriasis drug Prurisol completed a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. 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). 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 that 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.

Contact Information

  • INVESTOR AND MEDIA CONTACT:
    Cellceutix Corporation
    Leo Ehrlich
    Email contact