Cellceutix Corp (OTCMKTS:CTIX) provided update on the development activities of Prurisol. It stated that they are working on Prurisol, an oral anti-psoriasis drug under FDA guidance. The drug will obtain a 505(b)(2) approval pathway as the active moiety of experimental drug is the same as that of Ziagen®.
Cellceutix stated that a murine xenograft model contaning human psoriatic tissue demonstrated strong activity of drug Prurisol in treatment of all symptoms of psoriasis disease without reoccurrence. Following expedited 505(b)(2) pathway, the team concluded a Phase I crossover study successfully showing that Prurisol changes into abacavir in healthy people. During the end-of-Phase I meeting with the U.S. FDA, Cellceutix team was suggested that pending complete review of the Phase I data as well as long-term safety data for drug Prurisol for psoriasis would not be needed, as Ziagen long-term safety data can be referenced.
In December, 2014 the U.S. FDA granted Cellceutix permission to commence a Phase II study of Prurisol for psoriasis. At the same time, the company finished GMP manufacturing of placebo and Prurisol, main investigators and engaged vendors and entered into agreement with sites to commence the study. The management expect enrollment to commence in 2Q2015. Cellceutix is engaging the study at numerous clinical locations than originally decided, and wants to expedite the process as the manufacturing procedure took longer than expected.
Provided that psoriasis is termed as a chronic problem with limited number of effective therapies available in market, the National Psoriasis Foundation projects 125 million people suffering from problem worldwide. The company expect enrollment to conclude during 2015.
In last trading session, the stock price of Cellceutix Corp (OTCMKTS:CTIX) declined almost 2% to close the trading session at $2.47. The decline came at a share volume of 254,164 compared to average share volume of 225,497.