Orphan status for Hana's Marqibo

California, USA-based Hana Biosciences, a biopharmaceutical company focused on advancing cancer care, says that the Food and Drug Administration has granted Orphan Drug designation for Marqibo (vincristine sulfate liposomes injection) in the treatment of adult patients with acute lymphoblastic leukemia.

"This designation underscores the need for improved therapies in ALL, and supports our development strategy in areas of unmet medical need," commented Greg Berk, senior vice president and chief medical officer.

In December 2006, Hana filed a Special Protocol Assessment with the FDA for Marqibo in adults with ALL in second relapse and beyond. Subject to agreement with the agency on the SPA, Hana targets initiation of its pivotal trial in the first half of 2007.