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Replies to #83866 on Biotech Values
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poorgradstudent

09/21/09 2:19 PM

#83875 RE: genisi #83866

INCY:

From the presentation slides:

- 3 month, double blind, randomized, vehicle controlled study of 200 pts

- dosed once daily with vehicle, 0.5%, 1% or 1.5% formulation

- Primary endpoint: change in total lesion score (erythema + scaling + thickness)

- Secondary endpoints: percentage of patients achieving clear or almost clear lesions; change from baseline in the psoriasis area and sensitivity index (PASI)

Results:

- at 12 weeks, absolute change in lesion score was ~-1% for vehicle versus -2 to -2.5% for 0.5, 1 and 1.5% doses. All three were significantly different than vehicle with P < 0.05 for 0.5 and 1% and P < 0.01 for 1.5%.

- statistically significant change versus vehicle was observed beginning at two weeks for 1 and 1.5% formulations and 4 weeks for 0.5% formulation.

- can see some dose-response as the 0.5% formulation appears to have a more graded onset of activity than the 1 and 1.5% which are very similar.

- at week 12, 25% of patients in the 1% and 1.5% dose levels were clear or almost clear by PGA versus 6% in the vehicle group

- the webcast can be accessed from INCY's website... some nice, hand-picked pics can be viewed in the presentation.