Hana starts phase 2 clinical trial of Marqibo in acute lymphoblastic leukemia

By Lisa Kerner

Charlotte, N.C., Aug. 17 - Hana Biosciences Inc. said it began a multi-center phase 2 clinical trial of Marqibo (vincristine sulfate liposomes injection) in up to 44 patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

The primary objective of the phase 2 study is to assess efficacy of weekly doses of Marqibo plus pulse dexamethasone as measured by complete response rate, according to a company news release.

Secondary objectives are evaluation of safety and disease-free survival.

This study will support a phase 3 pivotal clinical trial of Marqibo for the treatment of ALL.

"Several trials in lymphoproliferative malignancies including non-Hodgkin's lymphoma and two phase 1 trials in ALL have shown promising potential for Marqibo to improve clinical outcomes," chief medical officer Greg Berk said in the release.

Marqibo uses vincristine, a Food and Drug Administration-approved standard chemotherapeutic used in most lymphoma and ALL regimens, and Inex Pharmaceutical Corp.'s sphingosome encapsulated technology.

Hana said about 4,000 cases of ALL are diagnosed annually in the United States and adult ALL reported cure rates seldom exceed 40%.

Based in South San Francisco, Calif., Hana is a biopharmaceutical company focused on advancing cancer care.

Inex is a Canadian biopharmaceutical company developing drugs and drug delivery systems to improve the treatment of cancer.

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