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news.The FDA has granted orphan drug designation to Innovive Pharmaceuticals's drug candidate tamibarotene for the treatment of adult patients with relapsed or refractory acute promyelocytic leukemia following treatment with all-trans-retinoic acid and arsenic trioxide.
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Innovive expects to begin enrollment in its pivotal Phase II study in the fourth quarter of 2007. Innovive has recently reached an agreement with the FDA on a special protocol assessment for a pivotal Phase II study of tamibarotene in relapsed or refractory acute promyelocytic leukemia (APL).
Known as STAR-1, the open-label, non-randomized, single-arm, multi-national study will enroll 50 adult patients with relapsed or refractory APL following treatment with all-trans-retinoic acid (ATRA) and arsenic trioxide (either sequentially or in combination).
Tamibarotene is a fully synthetic retinoid developed to specifically overcome resistance to ATRA and is currently approved in Japan for treatment of relapsed/refractory APL. In December 2006, Innovive acquired the exclusive North American license from TMRC to develop and commercialize the drug in the treatment of APL, with an option to include within the license the use of Tamibarotene in other fields in oncology including multiple myeloma, myelodysplastic syndrome, and solid tumors.