CuraGen and TopoTarget Initiate Phase I/II Clinical Trial of Belinostat (PXD101) Combination Therapy for Acute Myeloi...(l. The trial will also include pharma...),Health

The trial will also include pharmacokinetic and pharmacodynamic studies to evaluate the inhibition of HDAC enzymes in AML cells from patients treated with belinostat. Evaluation of the genes regulating proliferation and apoptosis (programmed cell death) and the differential gene expression in AML cells obtained both prior to and following treatment with belinostat will also be performed.

The trial is being led by Dr. Richard Schlenk, University Hospital of Ulm, Germany, in collaboration with clinical investigators in Germany, France and the UK.

"In preclinical studies, belinostat has shown potent growth-inhibitory activity on leukemic cell lines, and there is evidence that belinostat has an additive effect when combined with anthracyclines. Approximately 80% of AML patients who respond to first line treatments ultimately relapse and have limited treatment options. For patients over the age of 60, the available treatments have significant side effects that can limit their use in this patient population. We are therefore very interested in learning more about the role that HDAC inhibitors, such as belinostat, can play in the treatment of AML," commented Dr. Frank Armstrong, President and Chief Executive Officer of CuraGen.

About Acute Myeloid Leukemia (AML)

Approximately 14,000 cases of AML, the most common type of acute leukemia, are expected to be diagnosed in the United States during 2007 with more than 9,000 deaths attributed to this disease. The average age of a person diagnosed with AML is 65 years, with men more likely than women to develop AML. Several chemotherapeutic agents are currently used to treat AML and can lead to initial response rates above 50%. However, the five-year survival for AML patients under the age of 65 is approximately 33%, while patients over 65 years have a five-year survival rate of less than 5%. While some patients may remain in remission for extended periods of time, the majority of AML patients relap
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