( Napo Pharmaceuticals Inc. which focus...)Napo Obtains Special Protocol Assessment Agreement From FDA for Crofelemer,Health

Napo Pharmaceuticals, Inc., which focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners , today announced that under the Special Protocol Assessment (SPA) process it has obtained agreement with the United States Food and Drug Administration (FDA) for the design of its pivotal study protocol for crofelemer for the treatment of chronic diarrhea in people with HIV/AIDS (CRO-HIV).

The study, also referred to as the ADVENT trial, will be carried out under an FDA Fast Track designation. On Jan. 16, 2007, Napo met with the FDA under the Special Protocol Assessment Process on this adaptive design of its ADVENT trial. On March 14, 2007, Napo announced it had received approval from the principal independent review board (IRB) overseeing the ADVENT trial.

The ADVENT trial -- (Anti-Diarrhea therapy in HIV disease-Emerging treatmeNT concepts) is a randomized, double-blind, parallel-group, placebo- controlled, two-stage, adaptive design study to assess the efficacy and safety of crofelemer at 125mg, 250 mg and 500 mg oral doses twice daily (p.o.b.i.d) for the treatment of HIV-Associated Diarrhea.

The 'adaptive design' of the ADVENT trial -- Adaptive trial design has been advocated by the FDA to improve efficiency of clinical trials. The ADVENT trial will be executed in two stages. Stage I represents a dose selection stage and Stage II, a dose assessment stage. Four dose groups (placebo, 125 mg, 250 mg, and 500 mg) will be assessed in Stage I. When 50 subjects per group complete the initial efficacy dosing period (28 days), an interim analysis will be conducted to select an optimal single dose of crofelemer for Stage II. Stage II will continue until an additional 75 subjects are randomized both to this dose of crofelemer and the placebo, providing for 125 patients on placebo and 125 patients the selected crofelemer dose. The primary study analysis is
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