Cellceutix Corp (OTCMKTS:CTIX) released an update on the on-going development process of Prurisol. It disclosed that the company has been working on Prurisol which is an oral anti-psoriasis medication. The development activities are being carried out under FDA guidance, and the drug will be granted a 505(b)(2) authorization pathway as the active part of experimental drug candidate matches that of Ziagen®.
Cellceutix said that a murine xenograft model having human psoriatic tissue verified strong activity of drug in treatment of all indications of psoriasis disease without occurring again. Following expedited 505(b)(2) means, the team ended a Phase I crossover study indicating that drug Prurisol transforms into abacavir in healthy candidates. During the end-of-Phase one meeting with the FDA, team was instructed that pending review of the Phase one data and long-term safety findings for Prurisol for psoriasis disease would not be needed. It was possible as Ziagen long-term safety findings can act as reference base.
Cellceutix received permission to start a Phase two trial of Prurisol for psoriasis in last December. It was at the same time, the company ended GMP development of placebo and Prurisol, prime investigators and hired vendors and finalized deals with sites to initiate the study. The management intends to start enrollment process in 2Q2015. The study will be carried out at numerous clinical locations than decided before. The second objective of the company is to expedite the process so as to compensate for the delay in the manufacturing procedure.
Psoriasis is considered as a chronic problem that doesn’t have enough therapies available in market. Moreover, the National Psoriasis Foundation estimates more than 120 million people suffering from same disease worldwide. It indicates a vast market for the Cellceutix’s drug.
In last trading session, the stock price of CTIX declined 0.36% to close the trading session at $2.74. The decline came at a share volume of 155,829 compared to average share volume of 221,767.