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BEVERLY, MA--(Marketwired - August 06, 2015) - Cellceutix Corporation (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 commencement of the Company's Phase 2 trial of Prurisol for the treatment of plaque psoriasis. Recruitment is underway and Cellceutix expects www.clinicaltrials.gov to be updated shortly to reflect the current status of the trial. Cellceutix is developing Prurisol under guidance from the U.S. Food and Drug Administration that a 505(b)(2) designation is an acceptable pathway to expedite development of the compound.
The multi-center Phase 2 trial is designed to assess the efficacy and safety of Prurisol given orally compared to placebo in a randomized, double-blind setting in patients with mild to moderate chronic plaque psoriasis. The trial is expected to enroll 100 subjects. The primary efficacy endpoint will be the percentage of subjects with greater than or equal to a 2-point improvement in Investigator's Global Assessment (IGA) rating as defined by visual inspections of patient lesions. In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis as well as a xenograft model with human psoriatic tissue. As shown in the image, Prurisol removed virtually all signs of psoriasis with no reoccurrence of the lesions.
The trial is another milestone for Cellceutix and the culmination of years of work in its efforts to develop this drug for the chronic and often painful condition of plaque psoriasis. Despite advancements in therapeutics for treating this condition, there remains an area of great unmet medical need for an option to often-used biologics, which are known to have side effects and contraindications and eventually lose effectiveness to many patients. Prurisol is Cellceutix's efforts to provide a solution to this substantial market.
Separately, Cellceutix would like to announce the resignation of James Alexander, MD, MPH as Chief Operating Officer at Cellceutix due to the recent occurrence of a personal medical issue. It was unanticipated, however we are pleased Dr. Alexander will remain a consultant to Cellceutix on Kevetrin on a limited basis going forward.
"My time at Cellceutix has been very rewarding. Our first-in-man study of Kevetrin for patients with solid tumors has now enrolled over 40 subjects and established the safety profile of this promising compound," commented Dr. Alexander. "In addition, in 2015 we made significant advances in our clinical programs that target three different indications: the start of our Phase 2 study of brilacidin for the prevention of oral mucositis in cancer patients enrolling the first subjects; enrollment in our Phase 2 study of Prurisol for psoriasis is now getting underway; and a successful end-of-Phase 2 FDA meeting for brilacidin for the treatment of acute bacterial skin and skin structure infections was held three weeks ago. It has been my privilege to work with the excellent team of research and clinical development professionals at Cellceutix and am confident that they have a successful future in front of them."
"I wish to publically thank Dr. Alexander for his great commitment to Cellceutix. The efforts, hard work and long hours he contributed has been invaluable in advancing our pipeline and growing Cellceutix into the strong company it is today," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "Much younger people would have had a hard time keeping up with his pace. I am pleased to report that although he needed to substantially cut his workload, he agreed to do limited consulting for Cellceutix to help complete the Kevetrin Phase 1 program, a project that he feels passionate about to move into advanced clinical studies."
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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 oncology, dermatology and antimicrobial applications. 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 is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. 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 has commenced 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 and Phase 3 planning is now in progress. 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.
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.
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