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Thursday, August 25, 2016 7:11:16 AM
CTIX-0002 – Phase 2 Topline Clinical Trial Results
• A Phase 2 trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis was completed in May 2016.
• Prurisol met the primary endpoint (a 2-point IGA reduction) in 35% of all patients who received a dose of 200mg per day. Had one site,
where investigator non-compliance was suspected to have occurred been removed from overall data analyses, 43% of patients in the 200mg
dosing arm would have met the primary endpoint.
• Among patients with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46% of patients who received 200mg per day. This data was derived from analyses of all patients.
• Patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point IGA improvement.
• Patients reported improved general skin condition, e.g., skin felt moist and smoother.
• Prurisol was well-tolerated—just one Serious Adverse Event (SAE) occurred and it was in the 50mg dose group.
• PK results showed a dose-dependent increase in exposure and maximum plasma concentration of the drug. The elimination half-life was
similar in each of the three dosing levels (50mg, 100mg, 200mg), with an average of 1.3 hours. The clearance of the drug was also similar
across dosing levels, with an average of 80.1 liters per hour.
• In the second half of 2016, Cellceutix plans to initiate a Phase 2b trial of Prurisol, testing higher dosing regimens (300mg and 400mg arms),for the treatment of moderate-to-severe psoriasis. The company also is exploring Prurisol’s use in treating eczema.
http://cellceutix.com/wp-content/uploads/2014/06/Cellceutix_Corporate_Slide-Deck_DERMATOLOGY-Non-Confidential-July-2016-1-1.pdf
Good luck and GOD bless,
George
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