SOURCE: Cellceutix


May 31, 2016 07:00 ET

Cellceutix Releases Pharmacokinetics Data From Phase 2 Trial of Prurisol for Treating Psoriasis; Data Complements Efficacy Data Reported Last Week

BEVERLY, MA--(Marketwired - May 31, 2016) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to announce that the pharmacokinetics (PK) data on the recently completed Phase 2 trial of Prurisol as a novel oral treatment for plaque psoriasis has been received and is starting to be analyzed.

PK Data Complements Efficacy Data

The PK data complements the efficacy data reported last week by showing a dose-dependent increase in exposure and maximum plasma concentration of the drug. Further, the elimination half-life was similar in each of the three dosing levels (50mg, 100mg, 200mg), with an average of 1.3 hours. The clearance of the drug was also similar across dosing levels, with an average of 80.1 liters per hour.

Of particular note, the half-life of Prurisol is shorter than that of apremilast (Otezla®) (1.3 hours vs. 6 to 9 hours). This suggests Prurisol, which acts through immunodulatory mechanisms, may not be dependent upon long-term exposure in the body to exhibit activity. A shorter half-life also may play a role in minimizing side effects commonly observed with other psoriasis treatments. The longer the drug remains in the body, the greater potential for adverse interactions with other medications and foods.

Low Patient Dropout Rates

Patient withdrawals (also called discontinuance) from study arms, whether active or placebo, are often an indicator of general patient satisfaction or dissatisfaction of the drug under study. Additional data analyses revealed a higher dropout rate among patients on placebo compared to patients receiving Prurisol. The Company interprets this as a clear indicator of patient satisfaction.

Coupled with Prurisol's strong safety profile, minimal-to-no side effects, this insight reinforces qualitative endorsements expressed by many trial participants who reported feeling that their skin was moist, and not as dry, during the trial, as compared to before -- an insight providing rationale for possible expansion of Prurisol into other dermatological areas, including atopic dermatitis, or eczema.

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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

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. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. 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.

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