TAIPEI, Taiwan, Sept. 7, 2011 /PRNewswire-Asia/ -- TWi Biotechnology, Inc. announces the successful patient recruitment for the multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of AC-201 for the treatment of Type II Diabetes. A combined 240 patients from 13 US sites plus 8 Taiwan sites have been enrolled to the trial. With six-month treatment and one-month follow-up, completion of the trial data analysis is expected in the early second quarter of 2012. The trial's primary endpoint is defined as the change in glycated hemoglobin A1c (HbA1c) from baseline compared to placebo after twenty-four weeks of treatment. In addition, the study is powered to demonstrate additional benefits by monitoring various secondary endpoints including change in lipid profile, change in body weight, change in blood pressure and change in beta-cell function. Meanwhile, by measuring various biomarkers such as interleukin-1Beta, interleukin-1 receptor antagonist, interleukin-6, tumor necrosis factor-Alpha, high-sensitivity C-reactive protein, plasminogen activator inhibitor-1, transforming growth factor-Beta, and adiponectin, the company is able to stratify different patient groups in terms of clinical response, so as to develop personalized, preventive or therapeutic strategies.
"Through careful planning and execution, we are pleased with the efficient manner in which the twenty-one clinical sites, thirteen in US and eight in Taiwan, have enrolled 240 patients in the phase IIb study within 5 months since its inception, which is 4-month ahead of the expected schedule," stated Dr. M. Sherry Ku, President & CSO of TWi Biotech. "During the previous Phase IIa study, those patients with inadequate blood glucose control by multiple drug combinations of currently available oral anti-diabetic drugs were treated with AC-201 as an add-on therapy. The Phase IIa proof-of-concept study showed a mean reduction of 0.63% for HbA1c (
|SOURCE TWi Biotechnology, Inc.|
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