Hana Biosciences signs clinical trial agreement with National Cancer Institute

Mon. October 05, 2009; Posted: 09:22 AM

Oct 05, 2009 (Datamonitor via COMTEX) -- HNAB | Quote | Chart | News | PowerRating -- US-based biopharmaceutical company Hana Biosciences has entered into a clinical trial agreement with the Center for Cancer Research at the National Cancer Institute for the co-development of Marqibo in refractory pediatric cancer.

The five-year clinical trial agreement with the Center for Cancer Research (CCR) will initially focus on a Phase I trial to evaluate the safety, preliminary efficacy, pharmacokinetic profile and optimal dose of weekly Marqibo in children and adolescents with refractory cancer.

Following this Phase I trial, the company and CCR plan a Phase II trial in pediatric acute lymphoblastic leukemia (ALL), the most common cancer of childhood.

The company anticipates that this Phase II trial will facilitate subsequent studies of Marqibo in combination with standard chemotherapy regimens, and hopes that these in turn will lead to further improvements in the outcome for childhood cancer in the future.

Steven Deitcher, president and CEO of Hana Biosciences, said: "This agreement expands the clinical development programs for Marqibo and will complement our pivotal Phase II rALLy clinical trial evaluating Marqibo for the treatment of adults with ALL in second relapse.

"Our combined effort with the National Cancer Institute will further increase our understanding of Marqibo's unique activity and ability to supplant standard vincristine in children as well as adults."

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