Sunesis Completes Enrollment Of Voreloxin Phase 1b/2 Combination Trial In Acute Myeloid Leukemia

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials;  Blood / Hematology;  Cancer / Oncology
Article Date: 22 Jan 2010 - 1:00 PDT

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Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) reported that it has completed enrollment in its Phase 1b/2 clinical trial evaluating voreloxin, the company's lead compound, in combination with cytarabine, a widely used chemotherapy, in patients with relapsed or refractory acute myeloid leukemia (AML). A total of 110 patients with relapsed or refractory AML were enrolled in this study, including 50 primary refractory or first relapse AML patients enrolled in the expansion Phase 2 segments of the trial.

"Full enrollment of this trial marks an important step in our development of voreloxin in AML, a disease in which we plan to begin Phase 3 clinical testing later this year," said Daniel Swisher, Chief Executive Officer of Sunesis. "The Phase 1b/2 combination trial has already generated valuable data regarding voreloxin's anti-leukemic activity, including low 30- and 60-day all-cause mortality and favorable complete remission, safety and preliminary survival results in a difficult to treat patient population. Furthermore, we have treated nearly 300 AML patients to date, including 113 patients in REVEAL-1, the Phase 2 single agent voreloxin study in older patients unlikely to benefit from standard induction chemotherapy. We are very encouraged by the results of our AML clinical program, and believe voreloxin could provide a meaningful advancement to current standards of care."

The Phase 1b/2 trial is designed to evaluate the safety, pharmacokinetics and anti-leukemic activity of escalating doses of voreloxin when administered on days one and four with cytarabine, given either as a continuous infusion of 400 mg/m2 daily for five days or as a two hour IV bolus of 1 g/m2 daily for five days. A recommended pivotal dose-regimen of voreloxin used in combination with cytarabine has been identified based on results of the Phase 1b/2 clinical trial to date.

About Voreloxin

Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a fully enrolled single agent Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. A Phase 2 single agent trial in platinum-resistant ovarian cancer has also completed enrollment. Sunesis expects to begin Phase 3 testing in AML later in 2010.

About Acute Myeloid Leukemia

AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The Leukemia and Lymphoma Society estimates that nearly 13,000 new cases of AML will be diagnosed and approximately 9,000 deaths from AML will occur in the U.S. in 2009. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.

Source
Sunesis Pharmaceuticals

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