Xoma has initiated its Phase IIa clinical trial to evaluate Xoma 629, a topical gel formulation of an antimicrobial drug candidate, as a treatment for impetigo.
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The Phase IIa study is designed to assess the safety and efficacy of 1% Xoma 629 topical gel compared to a control cream indicated for impetigo. The clinical trial will evaluate 45 patients with primary impetigo in a two to one ratio of drug to control. Patients will be treated three times per day for five days.
The primary endpoint of clinical success will be analyzed one week after the last day of treatment. Preliminary efficacy will be evaluated for clinical and microbiologic response. Xoma expects to have preliminary data from the study in the fourth quarter of 2008.
In addition to studying Xoma 629 for impetigo, Xoma plans to commence clinical trials in the second half of 2008 for topical eradication of Staphylococcus aureus, including methicillin-sensitive Staphylococcus aureus and methicillin-resistant Staphylococcus aureus.
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