Xanthus Pharmaceuticals, Inc., a privately held oncology drug development company, has announced the completion of enrolment of its phase 2 study of Xanafide (amonafide malate) for the treatment of patients with secondary acute myeloid leukemia (AML).
"The completion of enrolment in this trial is another milestone Xanthus is pleased to announce as our pipeline of products continues to advance," stated Richard T. Dean, Ph.D., chief executive officer at Xanthus. "The progression of this therapeutic candidate is an example of Xanthus' commitment to the development of products that address hematological malignancies that pose an unmet medical need."
"We are very pleased to announce the completion of enrollment to this phase 2 study of Xanafide, and look forward to finishing the trial in due course," stated Robert L. Capizzi, M.D., senior vice president, and chief medical officer at Xanthus. "Due to an excellent rate of accrual, we have accomplished full enrolment months earlier than we had anticipated."
The phase 2 study is being conducted at multiple centers in North America and enrolled patients with secondary AML (patients with antecedent myelodysplastic syndrome or prior exposure to leukemogenic therapy). In this study, patients receive a daily dose of Xanafide for five days in combination with a standard dose of ara-C as a continuous infusion for 7 days. The primary endpoint of this study is the rate of complete remission, and secondary endpoints include duration of remission, overall survival and safety.
Xanafide (amonafide malate) is an ATP-independent topoisomerase 2 inhibitor that the company is developing for the treatment of secondary acute myeloid leukemia (AML) and related disorders. Patients with secondary AML represent a poor prognosis population in terms of response rates and duration of response to currently available therapies. While de novo AML is currently treated by approved drugs for this first-line indication, no effective therapies are approved specifically for patients with secondary
AML. In a phase 1 study conducted in patients with poor-risk AML, amonafide and ara-C exhibited particularly promising clinical results in patients with secondary AML and in some cases, resulted in complete or near-complete remissions.
Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel, clinical-stage, small-molecule oncology candidates through a management team whose accomplished track record encompasses all aspects of drug
development, from discovery through regulatory approval and commercialization. The Company is applying its expertise both to advance its current pipeline and expand it into indications of unmet medical need beyond oncology.