Cellceutix to Initiate Phase 2b Trial of Prurisol for Chronic Plaque Psoriasis

BEVERLY, MA–(Marketwired – July 07, 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 provide shareholders information on the next phases of clinical and corporate development following the recent appointment of Arthur P. Bertolino, MD, PhD, MBA as President and Chief Medical Officer.

“As I become even more familiar with the Cellceutix staff and pipeline, I continue to see a great deal of value and potential in our three lead compounds: Kevetrin, Brilacidin and Prurisol,” commented Dr. Bertolino. “I am working full-time with our team to define succinct clinical development strategies to advance these programs in a manner proven successful in my previous pharmaceutical experiences. My current emphasis is centered on efficient drug development and recruiting additional leading industry veterans for our staff and advisory board to assist in these matters. I believe this will translate into sustainable value for our company.”

Since successfully completing the initial Phase 2 trial of oral Prurisol for mild to moderate plaque psoriasis, the Company has fielded inquiries from many interested parties about the compound and has evaluated several options for the next stage of development. After a detailed analysis, the data clearly show that the most robust response to Prurisol was in patients with moderate psoriasis in the trial’s highest dosing arm (200mg), with no serious adverse events reported. Benefits were apparent by two weeks and showed further improvement by the end of the study at 12 weeks.

Cellceutix has begun preparing for a Phase 2b trial of Prurisol for patients with moderate to severe plaque psoriasis in order to better define appropriate dosing to achieve greatest clinical responses. The Company intends to increase the dosing beyond 200mg and evaluate patients using the Psoriasis Area and Severity Index (PASI) scoring method, which will enable better comparison to approved psoriasis drugs, including apremilast and biologics. In addition to evaluating efficacy in moderate to severe psoriasis, multiple secondary endpoints will be studied to provide insights regarding additional potential benefits of Prurisol compared to approved therapies. Our expectations are to initiate the trial late in the third quarter or early in the fourth quarter with top-line results in the second quarter of 2017.

“There is a significant opportunity in successfully developing a potent oral drug for chronic psoriasis. The spectrum of current treatment options spans multiple injectable biologics, oral apremilast, and a variety of topical creams,” said Dr. Bertolino. “A new oral drug that delivers substantial efficacy should command considerable market value and further attract the attention of pharmas looking to expand their dermatology offerings. I believe that Prurisol has that potential and that a refined second successful Phase 2 trial would further anchor the value that we already appreciate.”

“As we further define plans in the coming weeks for the development of Brilacidin and Kevetrin, we intend to also provide shareholders with additional updates on our clinical and pre-clinical program strategies,” concluded Dr. Bertolino.