Hana Biosciences has announced that the company has entered into a Clinical Trial Agreement (CTA) with the Center for Cancer Research (CCR) at the National Cancer Institute (NCI) for the co-development of Marqibo (vincristine sulfate liposomes injection) in refractory pediatric cancer.
The five-year CTA with the CCR will initially focus on a phase 1 trial to evaluate the safety, preliminary efficacy, pharmacokinetic profile, and optimal dose of weekly Marqibo in children and adolescents with refractory cancer.
Following the phase I trial, the company and CCR plan a phase 2 trial in pediatric acute lymphoblastic leukemia (ALL). The company anticipates that the phase 2 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.
Reportedly, Marqibo was determined to be generally tolerable and safe at the studied dose and resulted in a disease control rate of 34% in the very sick patient population.
Steven Deitcher, president and CEO of Hana Biosciences, said: “This agreement expands the clinical development programs for Marqibo and will complement our pivotal phase 2 rALLy clinical trial evaluating Marqibo for the treatment of adults with ALL in second relapse.”
Anne Hagey, chief medical officer of Hana Biosciences, said: “Our agreement with the NCI signifies the importance of vinca alkaloids like vincristine in the treatment of pediatric ALL and solid tumors like Wilm’s tumor, rhabdomyosarcoma, and neuroblastoma. The ability to enhance the dosing, tumor penetration, and pharmacokinetic profile of vincristine by the Marqibo formulation has the potential to improve outcomes in children with cancer, a typically underserved area of drug development.”