BEVERLY, MA–(Marketwired – August 6, 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 have 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.”