ycle of weekly Marqibo treatment. Safety
was assessed in the context of efficacy defined as the achievement of a complete
response with or without full blood count recovery.
Susan O'Brien, M.D., professor in the leukemia department at the University
of Texas MD Anderson Cancer Center in Houston, and rALLy study lead
investigator, said, "Clinical results from rALLy, as well as in previous ALL
trials, suggest that Marqibo could offer a unique salvage therapy for relapsed
ALL and therapeutic advantage over standard vincristine-containing chemotherapy
in patients with lymphoid malignancies."
The primary objective of the rALLy study is to assess the efficacy and
safety of single-agent, weekly Marqibo 2.25 mg/m2 with dosing based on actual
body surface area without the dose capping applied to standard vincristine.
Secondary objectives include evaluation of safety, response duration, and
overall survival. The patient population is defined as Philadelphia chromosome-
negative adult patients in second relapse, or those patients who relapsed
following two lines of anti-leukemia chemotherapy, including those who have
previously undergone stem cell transplantation. The rALLy trial is currently
being conducted at thirty-one clinical sites in the U.S., Canada, Germany,
Israel and the United Kingdom.
Hana Biosciences has received orphan drug and fast track designations for
Marqibo for the treatment of adult ALL from the U.S. Food and Drug
Administration. Marqibo has also received orphan drug designation from the
European Medicines Evaluation Agency in adult ALL.
About Marqibo(R) (vincristine sulfate liposomes injection)
Marqibo is a novel, targeted, Optisomal(TM) formulation of vincristine, a
widely-used chemotherapy, which has shown promising anti-cancer activity in
patients with ALL, non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in
several clinical trials. Vincri
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