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TOB

Re: smilingra post# 74314

Tuesday, 10/21/2014 10:41:32 AM

Tuesday, October 21, 2014 10:41:32 AM

Post# of 402724
Prurisol™ Autoimmune/Dermatology Studies

We are advancing Prurisol™ for the treatment of psoriasis and recently completed a Phase 1 crossover study to show that Prurisol™ converts to abacavir in humans as it did in animal models. Psoriasis is an immune-mediated inflammatory condition that affects approximately 3 percent of the world’s population, yet despite many available drugs, many people with psoriasis still face a poor quality of life because many approved drugs are still ineffective or come with serious side effects. We believe that a treatment for psoriasis, such as our drug Prurisol, which is taken orally and is a small molecule and not a biologic, is a very desirable drug for development as pills are the preferred method of delivery by patients. We have published images of mouse modelsdemonstrating the robust effect of Prurisol™ in our lab studies.

Based upon the data we have seen to date, we believe the Phase 1 trial met its primary endpoints. The FDA has provided us guidance that a 505(b)(2) pathway is an acceptable approach to expedite the development of Prurisol™. We have submitted our request to meet with the FDA as soon as possible to discuss our protocol to advance Prurisol™ into a larger-scale Phase 2/3 trial. -Link: CTIX PR




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