Innovive gets orphan status for tamibarotene

Innovive Pharmaceuticals says that the US Food and Drug Administration has granted Orphan Drug designation to the candidate tamibarotene in the treatment of adult patients with relapsed or refractory acute promyelocytic leukemia following treatment with all-trans-retinoic acid and arsenic trioxide.

Innovive recently reached an agreement with the FDA on a Special Protocol Assessment for a pivotal Phase II study of tamibarotene in relapsed or refractory APL. Known as STAR-1, the open-label, non-randomized, single-arm, multi-national trial will enroll 50 adult patients with relapsed or refractory APL following treatment with ATRA and arsenic trioxide (either sequentially or in combination). The primary objective is to determine the rate of durable complete response for tamibarotene therapy when administered as a single agent to adult patients with relapsed or refractory APL. The company expects to begin enrollment in the pivotal Phase II study in the fourth quarter of 2007.