Sunesis Pharmaceuticals (SNSS)

[califax]

Sunesis Pharma On Track To Initaite Late Stage Study Of Blood Cancer Drug Voreloxin - Update

6/2/2010 11:36 AM ET
http://www.rttnews.com/ArticleView.aspx?Id=1322846

Sunesis Pharmaceuticals, Inc. (SNSS: News ) on Wednesday said it is on track to initiate the phase 3 study of voreloxin, developed as a blood cancer drug, in the second half of 2010. The decision was made after the South San Francisco, California-based company received a written, scientific advice from the European Medicines Agency on the company's proposed plans for further development of voreloxin.

The consultative review process with the European Medicines Agency studied Sunesis' proposed plans for further development of voreloxin in acute myeloid leukemia, including the plans for a pivotal trial in patients with first relapsed or primary refractory acute myeloid leukemia.

Acute myeloid leukemia is a blood cancer that is mostly seen in older adults. The National Cancer Institute estimated that nearly 13,000 new cases of acute myeloid leukemia were diagnosed and about 9,000 deaths occurred in the US in 2009.

Sunesis' Voreloxin, a DNA-damaging agent, works by targeting cancer cells, inserts itself into the DNA of the cancer cells and finally causes the death of the cell.

The company added that both the European Medicines Agency's advice and the guidance given by US Food and Drug Administration in February will together provide a development clarity towards the submission for marketing approval of voreloxin.

The phase 3 trial, a multi-national, randomized, double-blind, placebo-controlled study, has the primary endpoint of overall survival, along with a favorable benefit-risk ratio in the trial. Both of these goals will enable the company for registration of voreloxin in both the U.S. and Europe.


The trial is expected to evaluate about 450 patients, testing voreloxin in combination with widely used chemotherapy Cytarabine.

The company, which focuses on the development and commercialization of oncology therapeutics, received an orphan drug designation for Voreloxin for the treatment of acute myeloid leukemia in November last year. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval and an exemption from user fees.

Voreloxin is also being tested as a potential treatment for platinum-resistant ovarian cancer, whose phase 2 trial demonstrated that the drug is generally well tolerated. Another product in the pipeline is SNS-314, a potential treatment for advanced solid tumors, which has completed its phase 1 study.