Under the pact, CTI is expected to initiate a Phase III trial in US and Europe in elderly patients with relapsed or refractory acute myeloid leukemia (AML) for potential approval by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
As per the terms of the agreement, Chroma is entitled to get $5m and a milestone payment of $5m when the AML pivotal trial is initiated, which is expected to occur in the fourth quarter of 2011.
CTI will take care of the development operations and commercialization activities in its territories and Chroma will oversee development operations and commercialization activities in the rest of the world.
Subject to a funding cap of $50 million for the first three years, CTI will be responsible for 75% of development costs and Chroma will be responsible for 25% of development costs.
CTI CEO James Bianco said Tosedostat, similar to drugs like Bortezomib and Lenalidomide, represents a departure from conventional cytotoxic chemotherapy toward more tumor selective targeted therapy that interferes with cellular pathways necessary for tumor survival.
"In initial clinical studies, tosedostat was well-tolerated, given orally once a day and produced encouraging response rates in difficult to treat patients with acute leukemia and a variety of blood related cancers," Bianco said.