November 10, 2009 — The US Food and Drug Administration has granted orphan drug designation for voreloxin (Sunesis Pharmaceuticals, Inc) in the treatment of acute myeloid leukemia (AML).
AML is a rapidly progressing disease that generally occurs in elderly patients who are often ineligible for standard therapies, resulting in a need for new treatment options.
Voreloxin is a first-in-class anticancer quinolone derivative that selectively intercalates and poisons topoisomerase II, leading to replication-dependent DNA damage, irreversible G2 arrest, and rapid apoptosis.
The benefits of voreloxin monotherapy are currently being evaluated in a phase 2 dose-regimen optimization trial (Response Evaluation of Voreloxin in AML [REVEAL-1]) of newly diagnosed elderly acute AML patients who are unlikely to benefit from standard induction chemotherapy. A second phase 2 study is being conducted of voreloxin in combination with cytarabine for relapsed/refractory AML.
"We believe voreloxin has the potential to impact the standard of care for AML and we continue to be encouraged by our progress. We are finalizing a registration strategy for voreloxin in AML and anticipate launching a pivotal trial in 2010," said Steven B. Ketchum, PhD, senior vice president of research and development at Sunesis in a company news release.
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