ATHX-105 for obesity.  In July 2007, we initiated a Phase I clinical trial for ATHX-105 in the United Kingdom. The Phase I clinical trial had a standard design evaluating safety and tolerability of single dose administration, dose escalation, and maximum tolerated dose, followed by a study examining the effect of daily administration of ATHX-105 to healthy overweight or obese individuals for a period of one week. Participants in the study had a target body mass index of 25 to 35, and included groups at several different dose levels or placebo. Safety monitoring included the assessment of various cardiovascular parameters. The primary objective of the Phase I clinical trial was to assess the short-term safety and tolerability of ATHX-105 and to establish an appropriate dose range for subsequent clinical studies that will be conducted in order to assess safety and effectiveness.

The Phase I clinical trial, which included 107 subjects, was completed in January 2008. The maximum tolerated dose for ATHX-105 was determined to be 100 mg, and the results from the clinical trial indicate that ATHX-105 was generally well-tolerated at dose levels below 100 mg. The drug appeared to be well-absorbed, resulting in good drug exposures following oral administration. There were no severe or serious adverse events observed in the clinical trial, no negative effects on cardiovascular, hematology or other clinical parameters, and no discontinuations due to adverse events. At high doses, the most common side effects included headache, nausea and dizziness, and these were generally mild and transient. Following a detailed analysis of the results of the clinical trial, the completion of certain required non-clinical studies and regulatory approval, we intend to initiate a Phase II clinical trial in the United States that will examine safety and effectiveness in clinically obese patients. We expect to begin the Phase II trial in the second half of 2008, and to report the results in the first half of 2009.