Cellceutix Concludes Last Patient Visit in Phase 2 FDA Trial of Oral Dosed Prurisol in Patients With Mild-to-Moderate Chronic Plaque Psoriasis
BEVERLY, MA--(Marketwired - March 17, 2016) - Cellceutix (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce the conclusion of the last patient visit in its randomized, double-blind Phase 2 trial of orally-administered Prurisol for the treatment of mild to moderate chronic plaque psoriasis. The unblinding of the study and top-line data is expected to be available in May. Although the data is still blinded, there were no safety items of concern.
"We eagerly await the Phase 2 results for Prurisol, now less than two months away," remarked Leo Ehrlich, Chief Executive Officer at Cellceutix. "We do significant laboratory research before engaging in a trial. That may be a reason why we have successfully completed three different studies on three very different compounds. The need for newer, non-biologic drugs, especially those that are easily-administered and well-tolerated for hard-to-treat psoriasis, is considerable. AbbVie's recent $595 million deal with Boehringer demonstrates the level of interest among large pharmaceutical companies in novel psoriasis treatments. Outside of Celgene's blockbuster Apremilast (Otezla), a drug expected to generate over $1 billion annually, only a handful of orally-administered drugs currently are in the pipeline for psoriasis. Prurisol is now one step closer to the goal line. We look forward to sharing the Prurisol trial results once they become known to us."
More information about the Phase 2 Trial of Prurisol for Chronic Psoriasis:
clinicaltrials.gov
More information about Prurisol:
Prurisol is a small molecule that acts through immune modulation and PRINS reduction and currently is being evaluated in a Phase 2 FDA trial under the U.S. Food and Drug Administration's 505(b)(2) pathway, which can help expedite a drug's approval by relying, in part, on clinical data from an already approved drug. In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis as well as 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.
cellceutix.com
Alerts:
Sign-up for Cellceutix email alerts is available at cellceutix.com
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 is in 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 |
